11.100.99 - Other standards related to laboratory medicine
ICS 11.100.99 Details
Other standards related to laboratory medicine
Autres normes relatives a la médecine de laboratoire
Drugi standardi v zvezi z laboratorijsko medicino
General Information
Frequently Asked Questions
ICS 11.100.99 is a classification code in the International Classification for Standards (ICS) system. It covers "Other standards related to laboratory medicine". The ICS is a hierarchical classification system used to organize international, regional, and national standards, facilitating the search and identification of standards across different fields.
There are 110 standards classified under ICS 11.100.99 (Other standards related to laboratory medicine). These standards are published by international and regional standardization bodies including ISO, IEC, CEN, CENELEC, and ETSI.
The International Classification for Standards (ICS) is a hierarchical classification system maintained by ISO to organize standards and related documents. It uses a three-level structure with field (2 digits), group (3 digits), and sub-group (2 digits) codes. The ICS helps users find standards by subject area and enables statistical analysis of standards development activities.
This document specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test.
This document does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.
- Standard69 pagesEnglish languagee-Library read for1 day
This document specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test.
This document does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.
- Standard69 pagesEnglish languagee-Library read for1 day
This document specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test. This document does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.
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SIGNIFICANCE AND USE
4.1 This practice specifies an in-vivo measurement of CWA decontamination on the skin.
4.2 CWA skin decontaminants will have different modes of action including absorption, adsorption, removal, chemical neutralization or some combination of the above. There is, therefore, no single representative in-vitro method for validation of decontamination efficacy of products for skin decontamination. For example, measuring the presence of a radiolabelled chemical warfare agent after chemical neutralization, may give a false positive results. It has been shown that if the agent has been chemically neutralized, the radiolabel may still be present in a non-toxic molecule. In addition, some chemical neutralization methods may break down the original agent, but the breakdown product is highly toxic. In the case of VX, hydrolysis produces a highly toxic product, EA2192 (S-(2-diisopropylaminoethyl) methylphosphonothioic acid (8).
4.3 This standard practice is of significance in that efficacy is thoroughly evaluated to the extent possible to represent use on human skin. In-vivo studies have demonstrated that simple chemical monitoring for disappearance of the chemical agent may not be sufficient to measure decontamination and neutralization effectiveness. A standard practice is needed for determining actual decontamination and neutralization by measuring the decrease in mortality or lesion size caused by the agent.
SCOPE
1.1 This practice establishes an in-vivo method for assessing the comparative efficacy of products used for the decontamination of chemical warfare agents (CWAs) on the skin.
1.2 This practice provides a quantitative efficacy comparison of different skin decontamination products.
1.3 To minimize the number of animals used, this in-vivo practice should be performed only after rigorous in-vitro studies of the candidate decontaminant, which can show the implied claims including chemical neutralization, decontamination studies on surfaces and appropriate testing such as cytotoxicity.
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with the use of decontamination products or CWAs. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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SCOPE
1.1 This specification establishes minimum requirements for the performance and labeling of isolation gowns intended for use by healthcare workers to provide protection for standard and transmission-based precautions. The intended use of this specification is to ensure the performance properties of isolation gowns for the protection of the wearer. Four levels of barrier properties for isolation gowns are specified in ANSI/AAMI PB 70, and are included in this specification for reference purposes.
1.2 There are other types of gowns that are used in healthcare settings, including: cover gowns, procedure gowns, comfort gowns, precaution gowns, and open-back gowns. All gowns not meeting the definition of isolation gown in 3.1.7 as defined by ANSI/AAMI PB70 are excluded from this standard.
1.3 This specification does not address protective clothing used for surgical applications, such as surgical gowns or decontamination gowns; protective clothing for the hands, such as surgical gloves, patient examination gloves, or other medical gloves; protective clothing for the head, such as goggles or face shields, surgical caps or hoods, surgical masks, or respirators; protective clothing for the feet, such as operating room shoes, shoe covers, or surgical boots; or other types of protective clothing and equipment worn by healthcare providers.
1.4 Units—The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the standard.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Technical specification11 pagesEnglish languagesale 15% off
- Technical specification11 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
4.1 Application of this guide will provide information on the acute toxicity of water-miscible metalworking fluids and will assist the user in evaluating the potential health hazards of the fluid and developing appropriate work practices. A water-miscible metalworking fluid is a concentrate designed to be diluted in water for use.
4.2 Water-miscible metalworking fluids are complex chemical mixtures. The United States Occupational Safety and Health Administration (OSHA) Hazard Communication Standard (see A1.8) outlines procedures for the hazard determination of mixtures and states that if a mixture has not been tested as a whole, then the mixture shall be assumed to present the same hazards as do the components that comprise 1 % (by weight or volume) or greater of the mixture, except that the mixture shall be assumed to present a carcinogenic hazard if it contains a component in concentrations of 0.1 % or greater, which is considered to be a carcinogen (as defined in OSHA Standard 29 CFR 1910.1200). The determination of when to test a mixture as a whole and which toxicity tests are appropriate for the product must be made by a health professional qualified in evaluating toxicological data.
4.3 Acute toxicology testing of water-miscible metalworking fluids consists of several individual tests including acute oral, dermal, or inhalation toxicity, eye irritation, skin irritation or corrosion, or both, skin sensitization, and sensory irritation. Certain protocols for acute oral, dermal, and inhalation toxicity tests are limit tests; further multi-dose testing (for example, Test Method E1103) should take place if mortality is noted on any of these tests. The referenced protocols specify the species and number of animals required. Selection of tests conducted should be designed to minimize the number of animals used.
4.3.1 Acute Oral Toxicity—Acute oral toxicity tests (see A1.1) provide information on health hazards likely to arise from short-term exposure by the ...
SCOPE
1.1 This guide defines acute animal toxicity tests and sets forth the references for procedures to assess the acute toxicity of water-miscible metalworking fluids as manufactured.
1.2 Although water-miscible metalworking fluids are typically used at high dilution, dilution rates vary widely. Additionally, there is potential for exposure to the metalworking fluid as manufactured.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Guide5 pagesEnglish languagesale 15% off
- Guide5 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
5.1 This test method is intended to assess a combination of inherent chemical irritation and mechanical irritation for products and materials expected to come into contact with the skin. It is a comparative approach whereby the potential irritation of a test material is compared to that of a reference material similar in form and composition. The reference material should have a known safety and irritation profile.
SCOPE
1.1 The behind-the-knee (BTK) method, using the popliteal fossa of human volunteers as a test site, simultaneously evaluates the inherent chemical irritation and the potential for mechanical irritation of substrates and products that are designed to come into repeated or extended close contact with the skin (see validation references (1-7)).2 This is a bilateral test comparing a test material to a reference material with a known safety profile.
1.2 This test method shall be used by qualified health care professionals experienced in good clinical practice (GCP) procedures.
1.3 This test method can be performed using human subjects on either intact or compromised skin. Testing should be performed on intact skin for test substrates or products expected to have contact with normal, intact skin, or for direct comparison to products with a known skin irritation profile. Testing can be performed on compromised skin for test substrates or products that may commonly come into contact with damaged skin (for example, skin with diaper rash, or chapped skin) or skin that is expected to be hydrated.
1.4 Visual scoring of erythema and dryness is performed by a trained skin grader on a predefined scale.
1.5 Prior to use in this test, materials shall undergo overall favorable biocompatibility testing consistent with the approach outlined in protocol Practice F748 or ISO 10993-1:2009. As a part of this series of testing, irritation per Practice F719 or ISO 10993-10 shall be conducted.
1.6 The values stated in inch-pound units are to be regarded as standard. No other units of measurement are included in this standard.
1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Standard24 pagesEnglish languagesale 15% off
- Standard24 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
4.1 The objective of this document is to provide guidance in the production, characterization, testing, and standardization of: (1) polymerizable collagen starting materials; and (2) collagen polymeric materials produced with polymerizable collagen formulations, used for surgical implants, substrates for TEMPs, vehicles for therapeutic cells and molecules, and 3D in-vitro tissue systems for basic research, drug development, and toxicity testing. This guide can be used as an aid in the selection, characterization, and standardization of the appropriate polymerizable collagen starting formulations as well as collagen polymeric materials prepared from polymerizable collagens for a specific use. Not all tests or parameters are applicable to all uses of collagen and users are expected to select and justify a subset of the tests for characterization purposes.
4.2 This guide can be used by the following types of users:
4.2.1 Manufacturers of polymerizable collagens and collagen polymeric materials who wish to set specifications for their products or provide characterization data for customers or users. They may also use the terminology and characterization sections to specify and differentiate the properties of polymerizable collagens and collagen polymeric materials.
4.2.2 Producers of collagen polymeric materials that use polymerizable collagen as starting materials. Producers may use this guide to evaluate and characterize multiple sources of polymerizable collagen. They may also use this guide to assist with evaluation and comparison of single or multiple sources of polymerizable collagen and collagen polymeric materials.
4.2.3 Researchers may use this guide as a reference for properties and test methods that can be used to reproducibly evaluate polymerizable collagens and collagen polymeric materials.
4.3 The collagen covered by this guide may be used in a broad range of applications, forms, or medical products, for example (but not limited to) wound an...
SCOPE
1.1 This guide is intended to provide characteristics, properties, test methods, and standardization approaches for evaluation and identification of specific polymerizable collagen formulations and collagen polymeric materials produced with these formulations.
1.2 This guide focuses on characterization of purified polymerizable forms of type I collagen, which is the most abundant collagen in mammalian connective tissues and organs, including skin, bone, tendon, and blood vessels. Polymerizable type I collagen may be derived from a variety of sources including, but not limited to, animal or cadaveric tissues, cell culture, recombinant cell culture, and chemical synthesis.
1.2.1 This guide covers evaluation of polymerizable collagens and collagen polymeric materials prepared from polymerizable collagens for use as a starting material for wound and hemostatic dressings, surgical implants, substrates for tissue-engineered medical products (TEMPs), delivery vehicles for therapeutic cells or molecules, and 3D in-vitro tissue systems for basic research, diagnostics, drug development, and toxicity testing. Most collagen products on the market today are regulated as devices since their primary intended purpose is not achieved through chemical action within or on the body. However, a medical product comprising polymerizable collagens or collagen polymeric materials may be regulated as a device, biologic, drug, or combination product depending on its intended use and primary mode of action.
1.2.2 Polymerizable collagen or collagen self-assembly implies that the collagen composition exhibits spontaneous macromolecular assembly from its components without the addition of exogenous factors such as cross-linking agents. Polymerizable collagens may include but are not limited to: (1) tissue-derived monomeric collagens, including tropocollagen or atelocollagen, and oligomeric collagens; (2) collagen proteins and peptides produce...
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- Guide20 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
4.1 This practice describes a cell adhesion method that can be used to provide a detachment percent at a given RCF for cells that have adhered to a substrate, typically for a short time. The information generated by this practice can be used to obtain a semi-quantitative measurement of the adhesion of cells to either an uncoated or pre-coated substrate, when compared to a reference (adherent) cell type on the same substrate. As described in Reyes and Garcia (2003), it is recommended that the 50 % point be used for either ligand concentration or RCF for the most robust measurement of adhesion strength. The adhesion may vary due to changes in the phenotype of the cells or as a result of the specific properties of the surface. The substrate may include tissue culture-treated polystyrene, biomaterials, or bioactive surfaces. If the substrate is a hydrogel, care must be taken to avoid cohesive failure in the hydrogel (that is, detached cells have pulled away fragments of gel). The coating may consist of (but is not limited to) the following: natural or synthetic biomaterials, hydrogels, components of extracellular matrix (ECM), ligands, adhesion or bioactive molecules, genes, or gene products. Cell concentration is also critical, as use of too high a concentration of cells may result in cells detaching as a sheet, rather than as individual cells. This centrifugation approach, once validated, may be applicable for quality control (QC) and product development. However, until the method is correlated to other measures of cell attachment, the current method should be run in parallel with other known measures of cell adhesion.
4.2 This practice does not cover methods to quantitate changes in gene expression, or changes in biomarkers, as identified by immunostaining. This practice additionally does not cover quantitative image analysis techniques. In some cases, the change in adhesive properties may reflect on the degree of differentiation or de-differentiation of the cells...
SCOPE
1.1 This practice covers a centrifugation cell adhesion assay that can be used to detect changes in adhesive characteristics of cells with passage or treatments. This approach measures the force required to detach cells from a substrate. Adhesion, among many variables, may vary due to changes in the phenotype of the cells.
1.2 This practice does not cover methods to verify the uniformity of coating of surfaces, nor does it cover methods for characterizing surfaces.
1.3 The cells may include adult, progenitor, or stem cells from any species. The types of cells may include chondrocytes, fibroblasts, osteoblast, islet cells, or other relevant adherent cell types.
1.4 This practice does not cover methods for isolating or harvesting of cells. This practice does not cover methods to quantitate changes in gene expression, or changes in biomarker type or concentration, as identified by immunostaining. Nor does this practice cover quantitative image analysis techniques.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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- Standard8 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
4.1 This document describes the basic principles that need to be followed to obtain a mean value of the Darcy permeability coefficient for structures that consist of a series of interconnected voids or pores. The coefficient is a measure of the permeability of the structure to fluid flowing through it that is driven by a pressure gradient created across it.
4.2 The technique is not sensitive to the presence of closed or blind-end pores (Fig. 1).
FIG. 1 Schematic of the Different Pores Types Found in Tissue Scaffolds. Fluid Flow Through the Structure is via the Open Pores
4.3 Values of the permeability coefficient can be used to compare the consistency of manufactured samples or to determine what the effect of changing one or more manufacturing settings has on permeability. They can also be used to assess the homogeneity and anisotropy of tissue scaffolds. Variability in the permeability coefficient can be also be indicative of:
4.3.1 Internal damage within the sample, for example, cracking or permanent deformation.
4.3.2 The presence of large voids, including trapped air bubbles, within the structure.
4.3.3 Surface effects such as a skin formed during manufacture.
4.3.4 Variable sample geometry.
4.4 This test method is based on the assumption that the flow rate through a given sample subjected to an applied pressure gradient is constant with time.
Note 1: If a steady-state flow condition isn’t reached, then this could be due to structural damage (that is, crack formation or the porous structure deformed as a result of the force being placed upon it by the fluid flowing through it). Sample deformation in the form of stretching (bowing) can also occur for less resilient structures as a result of high fluid flow rates. This topic is discussed in more detail in Section 7.
4.5 Care should be taken to ensure that hydrophobic materials are fully wetted out when using water or other aqueous-based liquids as permeants.
4.6 Conventionally, the p...
SCOPE
1.1 This guide describes test methods suitable for determining the mean Darcy permeability coefficient for a porous tissue scaffold, which is a measure of the rate at which a fluid, typically air or water, flows through it in response to an applied pressure gradient. This information can be used to optimize the structure of tissue scaffolds, to develop a consistent manufacturing process, and for quality assurance purposes.
1.2 The method is generally nondestructive and non-contaminating.
1.3 The method is not suitable for structures that are easily deformed or damaged. Some experimentation is usually required to assess the suitability of permeability testing for a particular material/structure and to optimize the experimental conditions.
1.4 Measures of permeability should not be considered as definitive metrics of the structure of porous tissue scaffolds and should complement measures obtained by other investigative techniques, for example, scanning electron microscopy, gas flow porometry, and micro-computer X-ray tomography (Guides F2450, F2603, and F3259).
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Guide7 pagesEnglish languagesale 15% off
- Guide7 pagesEnglish languagesale 15% off
This document specifies the requirements for competence to carry out reference measurement procedures in laboratory medicine, using the requirements of ISO/IEC 17025:2017 as a normative reference and listing additional requirements for calibration laboratories to perform their tasks adequately.
The relationship between clauses in this document and ISO/IEC 17025:2017 are summarized in Annex A.
Examinations of properties with results reported on a nominal or ordinal scale are not included.
This document is not applicable to medical laboratories.
NOTE Requirements for medical laboratories are specified in ISO 15189[1].
- Standard16 pagesEnglish languagee-Library read for1 day
ABSTRACT
This specification covers the classification, physical requirements, and testing of disposable glass micro Folin pipets suitable for use in micro techniques for the estimation of blood sugar by the Folin method. The pipets shall be made of Type 1, Class B borosilicate glass, or Type 2 soda lime glass. The physical properties to which the pipets shall adhere are design, dimensions, graduation lines, pipet nomenclature, color coding, marking permanency, and lot control. The pipets shall also be tested for capacity accuracy and coefficient of variation, and marking permanency.
SCOPE
1.1 This specification covers a glass disposable micro Folin pipet suitable for use in micro techniques for estimation of blood sugar by the Folin method.
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.3 The following precautionary statement pertains only to the test method portion, Section 8, of this specification. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Technical specification3 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
4.1 This guide is aimed at providing a range of in vivo models to aid in pre-clinical research and development of tissue-engineered medical products (TEMPs) intended for the clinical repair or regeneration of bone in the spine.
4.2 This guide includes a description of the animal models, surgical considerations, and tissue processing as well as the qualitative and quantitative analysis of tissue specimens.
4.3 The user is encouraged to utilize appropriate ASTM and other guidelines to conduct cytotoxicity and biocompatibility tests on materials, TEMPs, or both, prior to assessment of the in vivo models described herein.
4.4 It is recommended that safety testing be in accordance with the provisions of the FDA Good Laboratory Practices Regulations 21 CFR 58.
4.5 Safety and effectiveness studies to support regulatory submissions (for example, Investigational Device Exemption (IDE), Premarket Approval (PMA), 510K, Investigational New Drug (IND), or Biologics License Application (BLA) submissions in the U.S.) should conform to appropriate guidelines of the regulatory bodies for development of medical devices, biologics, or drugs.
4.6 Animal model outcomes are not necessarily predictive of human results and should, therefore, be interpreted cautiously with respect to potential applicability to human conditions.
SCOPE
1.1 This guide covers general guidelines for the pre-clinical in vivo assessment of tissue-engineered medical products (TEMPs) intended to repair or regenerate bone in an interbody and/or posterolateral spinal environment. TEMPs included in this guide may be composed of, but are not limited to, natural or synthetic biomaterials or composites thereof, and may contain cells or biologically active agents such as growth factors, synthetic peptides, plasmids, or cDNA. The models described in this document represent a stringent test of a material’s ability to induce and/or augment bone growth in the spinal environment.
1.2 While clinically TEMPs may be combined with hardware for initial stabilization or other purposes, the focus of this guide is on the appropriateness of the animal model chosen and evaluation of the TEMP-induced repair and as such does not focus on issues of components or constructs.
1.3 Guidelines include a description and rationale of various animal models for the in vivo assessment of the TEMP. The animal models utilize a range of species including rat (murine), rabbit (lapine), dog (canine), goat (caprine), pig (porcine), sheep (ovine), and non-human primate (primates). Outcome measures include in vivo assessments based on radiographic, histologic, and CT imaging as well as subsequent in vitro assessments of the repair, including histologic analyses and mechanical testing. All methods are described briefly and referenced. The user should refer to specific test methods for additional detail.
1.4 This guide is not intended to include the testing of raw materials, preparation of biomaterials, sterilization, or packaging of the product. ASTM standards for these steps are available in Referenced Documents (Section 2).
1.5 The use of any of the methods included in this guide may not produce a result that is consistent with clinical performance in one or more specific applications.
1.6 Other pre-clinical methods may also be appropriate, and this guide is not meant to exclude such methods. The material must be suitable for its intended purpose. Additional biological testing in this regard would be required.
1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.8 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.
1.9 This international standard was developed in accordance with internationally recognized prin...
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SIGNIFICANCE AND USE
5.1 The method described in this practice provides a procedure to rapidly generate pavement marking samples in the laboratory, suitable for the testing of applied pavement marking properties.
5.2 This practice is intended to provide uniform laboratory pavement marking samples that reduce the variability associated with obtaining pavement marking samples in the field.
5.3 This practice is particularly useful for directly comparing applied pavement marking properties as impacted by variations in materials, film thickness, and drop-on particle application rates for quality control or development purposes.
5.4 This practice can be used in evaluating pavement marking materials formulated and produced in the laboratory and for drop-on particles specifically made and prepared in the laboratory. It can also be used for testing materials that are already manufactured and either stored as work-in-process or placed in its final packaging. When testing manufactured materials in the finished goods state, it is extremely important that a representative sample of the pavement marking material and the drop-on particles are obtained for use, in order to draw the proper conclusions from any testing done on pavement marking samples made from these materials. For proper sampling of thermoplastic pavement markings in a finished good state, it is recommended to follow Practices D7307 and D7308. For proper sampling of liquid pavement marking with both single and multicomponent materials, it is recommended to follow Practice D8008.
SCOPE
1.1 This practice covers a procedure and apparatus for producing a representative laboratory pavement marking sample by applying a pavement marking material onto a suitable substrate, followed immediately with an application of drop-on particles consisting of retroreflective optics or other functional particles such as skid resistance particles suitable for laboratory testing or display. Examples of pavement marking materials appropriate for this practice would include waterborne traffic paint, solvent borne traffic paint, and plural component pavement markings such as epoxy, modified epoxy, polyurea, methyl methacrylate, and thermoplastic pavement markings. Plural component materials with extremely fast gel times might not be appropriate for this practice because the material gels too quickly to allow proper embedment of the drop-on particles.
1.2 The finished sample will consist of a pavement marking material applied in a liquid state to a sample substrate at the prescribed film thickness, with drop-on particles applied at the prescribed drop rate and embedment level on the surface of the pavement marking material, and then properly cured. The drop-on particles may consist of retroreflective optics such as glass beads or composite optics, or non-retroreflective particles such as skid resistant particles, or several of these items in combination.
1.3 The values stated in inch-pound units are to be regarded as the standard except where noted in the practice. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Standard15 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
4.1 This classification outlines aspects of TEMPs which includes their individual components.
4.2 The categories outlined in this classification are intended to list, identify, and group the areas pertinent to tissue-engineered medical products. This classification will be used by the Tissue-Engineered Medical Products subcommittees for the organization of the development of standards for the field of tissue engineering, TEMPs, and protocols for their use. The development of products from the new tissue engineering technologies necessitates creation and implementation of new standards (1).5
4.3 Since interactions may occur among the components used in TEMPs, new standard descriptions, test methods, and practices are needed to aid the evaluation of these interactions. The degree of overall risk for any given TEMP is reflected by the number and types of tests required to demonstrate product safety and efficacy.
SCOPE
1.1 This classification outlines the aspects of tissue-engineered medical products that will be developed as standards. This classification excludes traditional transplantation of organs and tissues as well as transplantation of living cells alone as cellular therapies.
1.2 This classification does not apply to any medical products of human origin regulated by the U.S. Food and Drug Administration under 21 CFR Parts 16 and 1270 and 21 CFR Parts 207, 807, and 1271.
1.3 This standard does not purport to address specific components covered in other standards. Any safety areas associated with the medical product's use will not be addressed in this standard. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Standard8 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
4.1 This guide covers animal implantation methods and analysis of the explanted DBM-containing material to determine whether a material or substance possesses osteoinductive potential, as defined by its ability to cause bone to form in vivo at a site that would otherwise not support bone formation, that is, heterotopically in a skeletal muscle implant site. For in vitro evaluation see Test Method F2131 for in vitro assessment of rhBMP 2.
4.2 The test methods described here may be suitable for defining product specifications, cGMP lot release testing, research evaluation, regulatory submission, and so forth, but a positive outcome should not be presumed to indicate that the product will be osteoinductive in a human clinical application. At present, the only direct assays to assess new bone formation are in vivo, since the property of bone conduction or induction can only be assessed in a heterotopic or orthotopic site in a living animal. When these products are implanted in an orthotopic site, osteogenic factors already present at the implantation site may contribute to and enhance bone formation in conjunction with the osteoconductive nature of the product. Thus, orthotopic implantation of products may result in bone formation by acting on existing bone-forming cells and not by causing mesenchymal stem cells to become osteochondroprogenitor cells. In contrast, when these products are implanted in a heterotopic site, no native osteogenic factors are present to contribute to or enhance bone formation. Thus, heterotopic implantation of products will only result in new bone formation by causing mesenchymal stem cells to become osteochondroprogenitor cells. In vitro assays have been described and some believe they may correlate to the results obtained from in vivo assays. However such in vitro assays measure only some of the biochemical marker(s) associated with in vivo bone formation and are therefore only indirect assays for osteoinductive activity or the capacity t...
SCOPE
1.1 This guide covers general guidelines to evaluate the effectiveness of DBM-containing products intended to cause and/or promote bone formation when implanted or injected in vivo. This guide is applicable to products that may be composed of one or more of the following components: natural biomaterials (such as demineralized bone), and synthetic biomaterials (such as calcium sulfate, glycerol, and reverse phase polymeric compounds) that act as additives, fillers, and/or excipients (radioprotective agents, preservatives, and/or handling agents) to make the demineralized bone easier to manipulate. It should not be assumed that products evaluated favorably using this guidance will form bone when used in a clinical setting. The primary purpose of this guide is to facilitate the equitable comparison of unique bone-forming products in in vivo heterotopic models of osteoinductivity. The purpose of this guide is not to exclude other established methods.
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with the use of DBM-containing bone-forming/promoting products. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices involved in the development of said products in accordance with applicable regulatory guidance documents and in implementing this guide to evaluate the bone-forming/promoting capabilities of the product.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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This document applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It specifies, in conjunction with ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control. Furthermore, it outlines the decision process for the residual risk acceptability, taking into account the balance of residual risk, as defined in ISO 14971, and expected medical benefit as compared to available alternatives. This document is intended to provide requirements and guidance on risk management related to the hazards typical of medical devices manufactured utilizing animal tissues or derivatives such as:
a) contamination by bacteria, moulds or yeasts;
b) contamination by viruses;
c) contamination by agents causing transmissible spongiform encephalopathies (TSE);
d) material responsible for undesired pyrogenic, immunological or toxicological reactions.
For parasites and other unclassified pathogenic entities, similar principles can apply.
This document does not stipulate levels of acceptability which, because they are determined by a multiplicity of factors, cannot be set down in such an international standard except for some particular derivatives mentioned in Annex C. Annex C stipulates levels of TSE risk acceptability for tallow derivatives, animal charcoal, milk and milk derivatives, wool derivatives and amino acids.
This document does not specify a quality management system for the control of all stages of production of medical devices.
This document does not cover the utilization of human tissues in medical devices.
NOTE 1 It is not a requirement of this document to have a full quality management system during manufacture. However, attention is drawn to international standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices.
NOTE 2 For guidance on the application of this document, see Annex A.
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This document specifies requirements for controls on the sourcing, collection, and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin other than in vitro diagnostic medical devices. It applies where required by the risk management process as described in ISO 22442‑1.
NOTE Selective sourcing is especially important for transmissible spongiform encephalopathy (TSE) risk management, i.e. when utilising animal tissue and/or their derivative originating from bovine, ovine and caprine species, deer, elk, mink or cats.
This document does not cover the utilization of human tissues in medical devices.
This document does not specify a quality management system for the control of all stages of production of medical devices.
- Standard26 pagesEnglish languagee-Library read for1 day
This document applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It specifies, in conjunction with ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control. Furthermore, it outlines the decision process for the residual risk acceptability, taking into account the balance of residual risk, as defined in ISO 14971, and expected medical benefit as compared to available alternatives. This document is intended to provide requirements and guidance on risk management related to the hazards typical of medical devices manufactured utilizing animal tissues or derivatives such as:
a) contamination by bacteria, moulds or yeasts;
b) contamination by viruses;
c) contamination by agents causing transmissible spongiform encephalopathies (TSE);
d) material responsible for undesired pyrogenic, immunological or toxicological reactions.
For parasites and other unclassified pathogenic entities, similar principles can apply.
This document does not stipulate levels of acceptability which, because they are determined by a multiplicity of factors, cannot be set down in such an international standard except for some particular derivatives mentioned in Annex C. Annex C stipulates levels of TSE risk acceptability for tallow derivatives, animal charcoal, milk and milk derivatives, wool derivatives and amino acids.
This document does not specify a quality management system for the control of all stages of production of medical devices.
This document does not cover the utilization of human tissues in medical devices.
NOTE 1 It is not a requirement of this document to have a full quality management system during manufacture. However, attention is drawn to international standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices.
NOTE 2 For guidance on the application of this document, see Annex A.
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ABSTRACT
This specification establishes a color-coding system to identify the anticoagulants used in coating pipets or containers not exceeding 1 mL in volume. Its purpose is to ensure that if a color code is used with an anticoagulant, all manufacturers will be encouraged, though not required, to use the same code.
SCOPE
1.1 This specification covers a system to identify the anticoagulants used in coating pipets or containers not exceeding 1 mL in volume.
1.2 The purpose of this specification is to ensure that if a color code is used with an anticoagulant, all manufacturers will be encouraged to use the same code; it is not intended to require color coding.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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ABSTRACT
This specification establishes a color-coding system for indicating capacity and identifying subdivisions in disposable glass and plastic laboratory pipets with multiple graduations, but excluding disposable prothrombin and disposable micropipets. This specification intends to ensure that when color coding is utilized, all manufacturers will be encouraged to use the same color for nominal value identification. Besides the colors to be used, requirements for durability, style, and location are also presented.
SCOPE
1.1 This specification provides a system for color coding disposable pipets (glass and plastic) with multiple graduations. The color will indicate capacity and subdivisions for identification purposes.
1.2 The intent of this specification is to ensure that when color coding is utilized, all manufacturers will be encouraged to use the same color for nominal value identification.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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ABSTRACT
This specification covers a disposable glass Westergren tube used for measuring the erythrocyte sedimentation rate. Covered by this specification are Type I (standard Westergren tube used in conventional racks only) and Type II (self-zeroing tubes used with racks that have convenient disposable tube features) Westergren tubes. The tubes shall be manufactured from borosilicate glass (Type I, Class B) or soda lime glass (Type II) into a one-piece construction that is free from visible defects, straight, and of uniform bore, with the ends of the tube cut at right angles to the tube axis and fire polished. In addition, Type II tubes shall be inserted wit an absorbent cotton plug. The tube shall be graduated, with graduation lines at right angles to the tube axis and in units of millimeters.
SCOPE
1.1 This specification covers a disposable tube used for measuring the erythrocyte sedimentation rate, ESR (the suspension stability of red cells in diluted, anti-coagulated human blood).
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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SIGNIFICANCE AND USE
4.1 The objective of this guide is to provide guidance in the characterization of Type I collagen as a starting material for surgical implants and substrates for tissue engineered medical products (TEMPs). This guide contains a listing of physical and chemical parameters that are directly related to the function of collagen. This guide can be used as an aid in the selection and characterization of the appropriate collagen starting material for the specific use. Not all tests or parameters are applicable to all uses of collagen.
4.2 The collagen covered by this guide may be used in a broad range of applications, forms, or medical products, for example (but not limited to) medical devices, tissue engineered medical products (TEMPs) or cell, drug, or DNA delivery devices for implantation. The use of collagen in a practical application should be based, among other factors, on biocompatibility and physical test data. Recommendations in this guide should not be interpreted as a guarantee of clinical success in any tissue engineered medical product or drug delivery application.
4.3 The following general areas should be considered when determining if the collagen supplied satisfies requirements for use in TEMPs. These are source of collagen, chemical and physical characterization and testing, and impurities profile.
4.4 The following documents or other appropriate guidances from appropriate regulatory bodies relating to the production, regulation, and regulatory approval of TEMPs products should be considered when determining if the collagen supplied satisfies requirements for use in TEMPs:
FDA CFR:
21 CFR 3: Product Jurisdiction:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/
CFRSearch.cfm?CFRPart=3
21 CFR 58: Good Laboratory Practice for Nonclinical Laboratory Studies:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/
CFRSearch.cfm?CFRPart=58
FDA/CDRH CFR and Guidances:
21 CFR Part 803: Medical Device ...
SCOPE
1.1 This guide for characterizing collagen-containing biomaterials is intended to provide characteristics, properties, and test methods for use by producers, manufacturers, and researchers to more clearly identify the specific collagen materials used. With greater than 20 types of collagen and the different properties of each, a single document would be cumbersome. This guide will focus on the characterization of Type I collagen, which is the most abundant collagen in mammals, especially in skin and bone. Collagen isolated from these sources may contain other types of collagen, for example, Type III and Type V. This guide does not provide specific parameters for any collagen product or mix of products or the acceptability of those products for the intended use. The collagen may be from any source including, but not limited to, animal or cadaveric sources, human cell culture, or recombinant sources. The biological, immunological, or toxicological properties of the collagen may vary, depending on the source material. The properties of the collagen prepared from each of the above sources must be thoroughly investigated, as the changes in the collagen properties as a function of source materials is not thoroughly understood. This guide is intended to focus on purified Type I collagen as a starting material for surgical implants and substrates for tissue engineered medical products (TEMPs); some methods may not be applicable for gelatin or tissue implants. This guide may serve as a template for characterization of other types of collagen.
1.2 The biological response to collagen in soft tissue has been well documented by a history of clinical use (1, 2)2 and laboratory studies (3-6). Biocompatibility and appropriateness of use for a specific application(s) is the responsibility of the product manufacturer.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this...
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ABSTRACT
This guide covers the basic components for the development of a sexual assault investigation protocol, with specific attention to the examination of assault scenes, victims and suspects of sexual assault, the recovery of testimonial, physical, and behavioral evidence, and the preservation and custody of physical evidence. This guide also outlines procedures requiring the experience of experts in a diversity of fields. A multidisciplinary team approach to sexual assault investigation is necessary and is the current standard of care. This team should include members skilled in the following disciplines: law enforcement, criminalistics, victim advocacy, and clinical, forensic practice.
SCOPE
1.1 This guide outlines the basic components for the development of a sexual violence investigation protocols, with specific attention to the examination of sexual violence scenes, victims and suspects of sexual violence, the recovery of testimonial, physical, and behavioral evidence, and the preservation and custody of physical evidence.
1.2 This guide outlines protocols requiring the experience of experts in a diversity of fields. A multidisciplinary team approach to sexual violence investigation is necessary and is the current standard of care. This team should include members skilled in the following disciplines: law enforcement, criminalistics, victim advocacy, and clinical, forensic practice.
1.3 This standard cannot replace knowledge, skills, or abilities acquired through education, training, and experience (see Practice E2917, Education and Training) and is to be used in conjunction with professional judgement by individuals with such discipline-specific knowledge, skills, and abilities.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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SIGNIFICANCE AND USE
5.1 These extraction procedures are the initial part of several test procedures used in the biocompatibility screening of plastics or other materials used in medical devices.
5.2 The limitations of the results obtained from this practice should be recognized. The choices of the extraction vehicle, duration of immersion, and temperature of the test are necessarily arbitrary. The specification of these conditions provides a basis for standardization and serves as a guide to investigators wishing to compare the relative resistance of various plastics or other materials to extraction vehicles.
5.3 Correlation of test results with the actual performance or serviceability of materials is necessarily dependent upon the similarity between the testing and end-use conditions (see 12.1.2 and Note 7).
5.4 Caution should be exercised in the understanding and intent of this practice as follows:
5.4.1 No allowance or distinction is made for variables such as end-use application and duration of use. Decisions on selection of tests to be done should be made based on Practice F748.
5.4.2 This practice was originally designed for use with nonporous, solid materials. Its application for other materials, such as those that are porous, absorptive (for example, sponge-like materials that are capable of absorbing liquid), or resorptive, should be considered with caution. Consideration should be given to altering the specified material-to-liquid ratio to allow additional liquid to fully hydrate the material and additional liquid or other methods to fully submerge the test specimen. Additional procedures that fully remove the extract liquid from the test specimen, such as pressure or physically squeezing the material, should also be considered as appropriate. Although no definitions are given in this practice for the following terms, such items as extraction vehicle surface tension at the specified extraction condition and test specimen physical structure should be taken into ...
SCOPE
1.1 This practice covers methods of extraction of medical plastics and may be applicable to other materials. This practice identifies a method for obtaining “extract liquid” for use in determining the biological response in preclinical testing. Further testing of the “extract liquid” is specified in other ASTM standards. The extract may undergo chemical analysis as part of the preclinical evaluation of the biological response, and the material after extraction may also be examined.
1.2 This practice may be used for, but is not limited to, the following areas: partial evaluation of raw materials, auditing materials within the manufacturing process, and testing final products. This practice may also be used as a reference method for the measurement of extractables in plastics used in medical devices. In general, it is the responsibility of the user of the standard to determine if the methods described in this standard are appropriate for the materials in their device.
1.3 This practice was initially developed for extraction of medical plastics not intended to undergo degradation or absorption during normal medical device usage. When applied to the extraction of absorbable materials, additional considerations may be necessary in the selection of extraction procedures and fluids.
1.4 For assessment of compatibility of the Single-use System material with the cell culture medium or the manufacturing processes used for cell-based therapeutics, vaccines, cell-based diagnostics, or other biopharmaceutical products, the user should refer to Guide E3231.
1.5 The values stated in SI units are to be regarded as standard. The values given in parentheses are mathematical conversions to inch-pound units that are provided for information only and are not considered standard.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of thi...
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SIGNIFICANCE AND USE
4.1 Materials that are to be in contact with the skin should not cause irritation to the skin. Since it is probably the substances leached from a material that cause the irritation, this practice provides for direct material-skin contact testing or for skin exposure to the liquid extract of the test material. The rationale for this rabbit test is that it is a comparatively quick and sensitive method which, through use over the years, has become a generally accepted method. Additionally, the albino rabbit allows for easy visualization of erythema and edema, which are the cardinal signs of skin irritation.
SCOPE
1.1 This practice covers a procedure by which the irritancy of a material may be assessed through contact with abraded and intact skin of rabbits.
1.2 The results of this practice depend upon the effectiveness with which contact between the skin and the test material is established and maintained. Because of the operator technique included in performing this test, it is important that the test be performed by personnel with appropriate training.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 This standard may involve hazardous materials, operations, and equipment. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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SIGNIFICANCE AND USE
5.1 This technique involves a chemical-precipitation reaction between methamphetamine or amphetamine and the precipitating reagent. The habit and the aggregation of the crystals formed could be used to distinguish methamphetamine and amphetamine from other drugs, as well as from each other.
SCOPE
1.1 This practice describes procedures applicable to the analysis of methamphetamine and amphetamine using microcrystal tests (1-6).2
1.2 These procedures are applicable to methamphetamine and amphetamine, which are present in solid dosage form or an injectable liquid form. These procedures are not typically applicable to the analysis of methamphetamine and amphetamine in biological samples.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 These procedures could generate observations indicating a positive test for methamphetamine or amphetamine which could be incorporated into the analytical scheme as defined by the laboratory.
1.5 This standard cannot replace knowledge, skills, or abilities acquired through appropriate education, training, and experience (see Practice E2326) and is to be used in conjunction with sound professional judgment by individuals with such discipline-specific knowledge, skills, and abilities.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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SIGNIFICANCE AND USE
5.1 This guide describes markers involved in myoblast differentiation that can be used to screen stem cells to help define myogenic capacity. Stem cells include pluripotent and multipotent stem cells capable of differentiating into several different mesenchymal cells, including skeletal muscle myoblasts.
5.2 To assess myogenesis in cells derived and not derived from muscle, markers are measured to accurately define the changes in transcription and structural proteins that regulate differentiation, fusion, and myotube formation. Discussion of these markers is important to understand why they are recommended.
5.3 Myogenic Differentiation:
5.3.1 Myogenic differentiation is a highly regulated process controlled by paired box (Pax) transcription factors and the myogenic regulatory factor (MRF) family. During early differentiation in adults, myogenic progenitors such as activated satellite cells or myoblasts express Pax3 and Pax7. Pax3 and Pax7 transcription factors switch the cells toward a myogenic fate, and repress myocyte differentiation (2), priming the cell for later MRFs. To form muscle, the family of MRFs is required to terminally differentiate myoblasts and form myofibers. These regulatory proteins belong to a superfamily of basic helix-loop-helix transcription factors that consists of myogenic differentiation factor 1 (Myod1), myogenic factor 5 (Myf5), myogenin (Myog), and myogenic factor 6 (Myf6). In the initial stages of myogenic differentiation, Myod1 and Myf5 are the first MRFs to be expressed, and trigger increased production of Myog and Myf6 (3). Increased intracellular Myog and Myf6 induces terminal differentiation of myoblasts into myocytes, leading to fused myotubes.
5.4 Forming Myotubes:
5.4.1 While myogenic markers describe differentiation, fusion into multinucleated myotubes is an important factor in muscle biology. Myoblasts differentiate into a fusogenic phenotype characterized by multiple fusion markers. One marker of note is m-c...
SCOPE
1.1 Myogenic differentiation is a process regulated by specific transcription factors and signaling molecules that have been shown to induce a myogenic phenotype. Transcription factors mark the stages of myogenesis and act as benchmarks for use in myogenic assays.
1.2 This guide applies to mammalian cells but does not apply to non-mammalian cells as the myogenic markers for non-mammalian cells can be different than those described here.
1.3 This guide proposes appropriate markers to measure when conducting myogenic differentiation assays. This guide describes the stages for multipotent stem cell differentiation toward myoblasts and myotubes. This guide provides information about the appropriate methods to determine myogenic differentiation. This guide does not provide information about media, supplements, or substrates that drive differentiation toward a myogenic phenotype.
1.4 The purpose of this guide is to act as an aid for work performed in the area of skeletal myogenesis. Using this guide, researchers should be able to understand which skeletal muscle markers are best suited for experiments. This guide will improve consistency for studies of myogenic differentiation of multipotent stem cells by identifying appropriate markers for each stage leading to myocyte differentiation. It should be noted that myoblast differentiation in vitro may not be predictive of results that may be obtained in vivo.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Gu...
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ABSTRACT
This specification covers the physical requirements and corresponding test methods for disposable glass Prothrombin pipets suitable for use in micro techniques for estimating Prothrombin time. The pipet shall be made of Type 1, Class B borosilicate glass, or Type 2 soda lime glass. The physical properties to which the pipets should adhere to are those for design, dimensions, capacity (accuracy and coefficient of variation), graduation lines, pipet nomenclature, blow-out delivery, color coding, marking permanency, and lot control.
SCOPE
1.1 This specification covers a glass disposable Prothrombin pipet suitable for use in micro techniques for estimation of Prothrombin time.
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.3 This precautionary statement pertains only to the test method portion, Section 8, of this specification. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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This document specifies the requirements for competence to carry out reference measurement procedures in laboratory medicine, using the requirements of ISO/IEC 17025:2017 as a normative reference and listing additional requirements for calibration laboratories to perform their tasks adequately. The relationship between clauses in this document and ISO/IEC 17025:2017 are summarized in Annex A. Examinations of properties with results reported on a nominal or ordinal scale are not included. This document is not applicable to medical laboratories. NOTE Requirements for medical laboratories are specified in ISO 15189[1].
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ABSTRACT
This specification covers polysulfone resin (poly(oxy-p-phenylenesulfonyl-p-phenyleneoxy-p-phenyleneisopropylidene-p-phenylene)) for medical applications. Requirements and associated test methods for a form of this thermoplastic intended for use in manufacturing medical devices or components of medical devices are provided. The use of this resin in medical devices should be restricted to nonimplant applications until biocompatibility evaluations appropriate for the intended applications are successfully completed. The molecular weight of the resin shall be determined by osmotic pressure in monochlorobenzene. The polysulfone resin shall yield an infrared transmittance spectrum that exhibits major transmittance bands only at the same wavelengths as that of a reference spectrum. Medical devices made of polysulfone may be repeatedly sterilized through steam, ethylene oxide, irradiation, and dry heat sterilization, among others. The polysulfone resin shall be tested for nonvolatile content and melt flow, and shall conform to the specified electrical, physical and mechanical, and thermal properties.
SCOPE
1.1 This specification covers polysulfone resin (poly(oxy-1,4-phenylenesulfonyl-1,4–phenylene (dimethylmethylene)-1,4–phenylene)) as defined in ISO 25137–1, supplied by a vendor in virgin form (pellets, powder, fabricated forms and so forth) for medical applications. This specification provides requirements and associated test methods for this thermoplastic when it is intended for use in manufacturing medical devices or components of medical devices.
1.2 As with any material, some characteristics may be altered by the processing techniques (such as molding, extrusion, machining, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of this resin should be evaluated using test methods which are appropriate to ensure safety and efficacy as agreed upon by the vendor, purchaser, and regulating bodies.
1.3 The standard allows for designation of polysulfone resin for all medical applications. The actual extent of performance and suitability for a specific application must be evaluated by the vendor, purchaser, and regulating bodies.
1.4 The properties included in this specification are those applicable for unfilled polysulfone (PSU) polymers with the addition of colorants and processing aids. Indicated properties are for injection molded forms. Forms containing fillers or other additives, as well as polymer blends which contain PSU, or reclaimed materials, are not covered by this specification.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 When evaluating material in accordance with this specification, hazardous materials, operations, and equipment may be involved. This standard does not purport to address all of the concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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- Technical specification4 pagesEnglish languagesale 15% off
ABSTRACT
This specification covers the general, physical property, and biocompatibility requirements, and the associated test methods for establishing a reasonable level of confidence concerning the performance of unfilled thermoplastic polycarbonate resin for use in the manufacture of medical devices or the components thereof.
SCOPE
1.1 This specification covers polycarbonate resin and provides requirements and associated test methods for this thermoplastic when it is to be used in the manufacture of medical devices or components of medical devices.
1.2 As with any material, some characteristics may be altered by the processing techniques (such as molding, extrusion, machining, assembly, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of this resin should be evaluated using those test methods that are appropriate to assure safety and efficacy.
1.3 The properties included in this specification are those applicable for polycarbonate only. The biocompatibility of plastic compounds made up of polycarbonate resin containing colorants, fillers, processing aids, or other additives, as well as polymer blends which contain polycarbonate, should not be assumed. The biocompatibility of these modified polycarbonates must be established by testing the final (end-use) compositions using the appropriate methods of evaluation. In addition, the biocompatibility of the material depends to a large degree on the nature of the end-use application. It is, therefore, necessary to specify a set of biocompatibility test methods for each new and distinct application.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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This document specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test. This document does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.
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This document defines terms used in the ISO 21043 series of standards.
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SIGNIFICANCE AND USE
4.1 This guide contains a listing of those characterization parameters that are directly related to the functionality of chitosan. This guide can be used as an aid in the selection and characterization of the appropriate chitosan or chitosan salt for a particular application. This standard is intended to give guidance in the methods and types of testing necessary to properly characterize, assess, and ensure consistency in the performance of a particular chitosan. It may have use in the regulation of devices containing chitosan by appropriate authorities.
4.2 The chitosan salts covered by this guide may be gelled, extruded, or otherwise formulated into biomedical devices for use as tissue-engineered medical products or drug delivery devices for implantation as determined to be appropriate, based on supporting biocompatibility and physical test data. Recommendations in this guide should not be interpreted as a guarantee of clinical success in any tissue-engineered medical product or drug delivery application.
4.3 To ensure that the material supplied satisfies requirements for use in TEMPs, several general areas of characterization should be considered. These include identity of chitosan, physical and chemical characterization and testing, impurities profile, and performance-related tests.
SCOPE
1.1 This guide covers the evaluation of chitosan salts suitable for use in biomedical or pharmaceutical applications, or both, including, but not limited to, tissue-engineered medical products (TEMPS).
1.2 This guide addresses key parameters relevant for the functionality, characterization, and purity of chitosan salts.
1.3 As with any material, some characteristics of chitosan may be altered by processing techniques (such as molding, extrusion, machining, assembly, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of this polymer should be evaluated using test methods that are appropriate to ensure safety and efficacy.
1.4 Warning—Mercury has been designated by EPA and many state agencies as a hazardous material that can cause central nervous system, kidney, and liver damage. Mercury, or its vapor, may be hazardous to health and corrosive to materials. Caution should be taken when handling mercury and mercury-containing products. See the applicable product Material Safety Data Sheet (MSDS) for details and EPA’s website (http://www.epa.gov/mercury/faq.htm) for additional information. Users should be aware that selling mercury or mercury-containing products, or both, in your state may be prohibited by state law.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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SIGNIFICANCE AND USE
4.1 The degree of deacetylation of chitosan salts is an important characterization parameter since the charge density of the chitosan molecule is responsible for potential biological and functional effects.
4.2 The degree of deacetylation (% DDA) of water-soluble chitosan salts can be determined by 1H nuclear magnetic resonance spectroscopy (1H NMR). Several workers have reported on the NMR determination of chemical composition and sequential arrangement of monomer units in chitin and chitosan. The test method described is primarily based on the work of Vårum et al. (1991),5 which represents the first publication on routine determination of chemical composition in chitosans by solution state 1H NMR spectroscopy. This test method is applicable for determining the % DDA of chitosan chloride and chitosan glutamate salts. It is a simple, rapid, and suitable method for routine use. Quantitative 1H NMR spectroscopy reports directly on the relative concentration of chemically distinct protons in the sample, consequently, no assumptions, calibration curves or calculations other than determination of relative signal intensity ratios are necessary.
4.3 In order to obtain well-resolved NMR spectra, depolymerization of chitosans to a number average degree of polymerization (DPn) of ~15 to 30 is required. This reduces the viscosity and increases the mobility of the molecules. Although there are several options for depolymerization of chitosans, the most convenient procedure is that of nitrous acid degradation in deuterated water. The reaction is selective, stoichiometric with respect to GlcN, rapid, and easily controlled (Allan & Peyron, 1995).6 The reaction selectively cleaves after a GlcN-residue, transforming it into 2,5-anhydro-D-mannose (chitose), consequently, depletion of GlcN after depolymerization is expected. On the other hand, the chitose unit displays characteristic 1H NMR signals the intensity of which may be estimated and utilized in the calculation of % DDA,...
SCOPE
1.1 This test method covers the determination of the degree of deacetylation in chitosan and chitosan salts intended for use in biomedical and pharmaceutical applications as well as in Tissue Engineered Medical Products (TEMPs) by high-resolution proton NMR (1H NMR). A guide for the characterization of chitosan salts has been published as Guide F2103.
1.2 The test method is applicable for determining the degree of deacetylation (% DDA) of chitosan chloride and chitosan glutamate salts and is valid for % DDA values from 50 up to and including 99. It is simple, rapid, and suitable for routine use. Knowledge of the degree of deacetylation is important for an understanding of the functionality of chitosan salts in TEMP formulations and applications. This test method will assist end users in choosing the correct chitosan for their particular application. Chitosan salts may have utility in drug delivery applications, as scaffold or matrix material, and in cell and tissue encapsulation applications.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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SIGNIFICANCE AND USE
5.1 This test method is suitable for determination of the total amount of extractable residue in metallic medical components. Extractable residue includes aqueous and non-aqueous residue, as well as non-soluble residue.
5.2 This test method recommends the use of a sonication technique to extract residue from the medical component. Other techniques, such as solvent reflux extraction, could be used but have been shown to be less efficient in some tests, as discussed in X1.2.
5.3 This test method is not applicable for evaluating the extractable residue for the reuse of a single-use component (SUD).
SCOPE
1.1 This test method covers the quantitative assessment of the amount of residue obtained from metallic medical components when extracted with aqueous or organic solvents.
1.2 This test method does not advocate an acceptable level of cleanliness. It identifies two techniques to quantify extractable residue on metallic medical components. In addition, it is recognized that this test method may not be the only method to determine and quantify extractables.
1.3 Although these methods may give the investigator a means to compare the relative levels of component cleanliness, it is recognized that some forms of component residue may not be accounted for by these methods.
1.4 The applicability of these general gravimetric methods have been demonstrated by many literature reports; however, the specific suitability for applications to all-metal medical components will be validated by an Interlaboratory Study (ILS) conducted according to Practice E691.
1.5 This test method is not intended to evaluate the residue level in medical components that have been cleaned for reuse. This test method is also not intended to extract residue for use in biocompatibility testing.
Note 1: For extraction of samples intended for the biological evaluation of devices or materials, refer to ISO 10993–12.
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.7 This standard may involve hazardous or environmentally-restricted materials, operations, and equipment. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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SIGNIFICANCE AND USE
4.1 Tissue-engineered cartilage is prepared by seeding stem cells or chondrocytes in a three-dimensional biodegradable scaffold under controlled growth conditions. It is expected that the cells will differentiate towards chondrogenic lineage and produce an ample amount of cartilage extracellular matrix proteins, proteoglycans, and collagen type-II. Longitudinal assessment is needed weekly for the first few weeks in vitro and monthly at a later stage in vivo to determine the growth rate of tissue-engineered cartilage. Traditional testing methods such as histological staining, mechanical testing, and qPCR are invasive, destructive, and cannot be performed in vivo after the transplantation of engineered tissue as a regenerative treatment. In the regenerative medicine of cartilage, it is important to evaluate whether the implanted tissue regenerates as an articular cartilage over time. MRI is the only available non-invasive imaging modality that is utilized for post-operative monitoring and assessment of cartilage regeneration in clinics. Therefore, it is important to evaluate tissue-engineered cartilage using MRI at the preclinical stage as well.
4.7.1 The change in calculated relaxation rate, R2(ECM), using Eq 1 have been found to be positively correlated with tissue growth (3, 6).
SCOPE
1.1 This standard is intended as a standard test method for engineered cartilage tissue growth evaluation using MRI.
1.2 This standard is intended for use in the development of tissue engineering regenerative medical products for cartilage damages, such as in knee, hip, or shoulder joints.
1.3 This standard has been prepared for evaluation of engineered cartilage tissue growth at the preclinical stage and summarizes results from tissue growth evaluation of tissue-engineered cartilage in a few notable cases using water spin-spin relaxation time, T2, in vitro and in vivo in small animal models.
1.4 This standard uses the change in mean T2 values as a function of growth time to evaluate the tissue growth of engineered cartilage.
1.5 This standard provides a method to remove the scaffold contribution to the tissue growth evaluation.
1.6 Information in this standard is intended to be applicable to most porous natural and synthetic polymers used as a scaffold in engineered cartilage, such as alginate, agarose, collagen, chitosan, and poly-lactic-co-glycolic acid (PLGA). However, some materials (both synthetic and natural) may require unique or varied methods of MRI evaluation that are not covered in this test method.
1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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SIGNIFICANCE AND USE
4.1 This guide covers animal implantation methods and analysis of bone void fillers to determine whether a material or substance leads to lumbar intertransverse process spinal fusion, as defined by its ability to cause bone to form in vivo.
SCOPE
1.1 Historically, the single-level rabbit posterolateral, or intertransverse, lumbar spine fusion model was developed and reported on by Dr. Scott Boden, et. al. (Emory Spine Center for Orthopedics) and the model has been proposed as a non-clinical model which may be used to replicate clinically-relevant fusion rates for iliac crest autograft in the posterolateral spine (1, 2).2 This model is used routinely in submissions to regulatory bodies for the purpose of evaluating the potential efficacy of bone void filler materials as compared to other materials or iliac crest autograft to effect spinal posterolateral fusion. The use of this standard’s recommendations as part of a regulatory submission does not provide any guarantee of regulatory clearance and should be considered as a part of the data provided for regulatory submission.
1.2 This guide covers general guidelines to evaluate the effectiveness of products intended to cause and/or promote bone formation in the lumbar intertransverse process spinal fusion model in vivo. This guide is applicable to products that may be composed of one or more of the following components: natural biomaterials (such as demineralized bone), and synthetic biomaterials (such as calcium sulfate, glycerol, and reverse phase polymeric compounds) that act as additives, fillers, and/or excipients (radioprotective agents, preservatives, and/or handling agents). It should not be assumed that products evaluated favorably using this guidance will form bone when used in a clinical setting. The primary purpose of this guide is to facilitate the equitable comparison of bone void fillers and/or autograft extender products in vivo. The purpose of this guide is not to exclude other established methods.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with the use of bone void fillers. It is the responsibility of the user of this standard to establish appropriate safety and health practices involved in the development of said products in accordance with applicable regulatory guidance documents and in implementing this guide to evaluate the bone-forming/promoting capabilities of the product.
1.5 This standard does not purport to address the requirements under 21 CFR Part 58 concerning Good Laboratory Practices or international standard counterpart OECD Principles of Good Laboratory Practice (GLP). It is the responsibility of the sponsor of the study to understand the requirements for conduct of animal studies whereby the data may be used to support premarket applications, including requirements for personnel, protocol content, record retention and animal husbandry.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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ISO 18385:2016 specifies requirements for the production of products used in the collection, storage, and analysis of biological material for forensic DNA purposes, but not those consumables and reagents used in post-amplification analysis. The consumables and reagents covered by this International Standard include those used for evidence collection (sampling kits), such as swabs, containers, and packaging, and also products used in the analysis of DNA samples, such as tubes and other plasticware, disposable laboratory coats, gloves, and other consumables. ISO 18385:2016 applies to the production of consumables and reagents which do not require cleaning for continued use. This International Standard does not cover technical product specifications (i.e. product design). ISO 18385:2016 excludes microbiological testing. ISO 18385:2016 specifies a requirement for manufacturers to minimize the risk of occurrence of detectable human nuclear DNA contamination in products used by the global forensic community.
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ABSTRACT
This specification covers the properties for polyethylene plastics for use in medical device applications involving human tissue contact devices, short term indwellings, and fluid transfer devices. Biocompatibility tests must be conducted on the final products as the biocompatibility of these materials as a class has not been established. Plyethylene plastics should consist of basic polymers with ethylene as essentially the sole monomer. The compound may contain optional adjuvant substances required in polymer production or fabrication. The final compound should yield a consistent absorption spectrum characteristic of the established formulation. The polyethylene plastics should be tested using the specified physical test procedures for density, melt flow, tensile properties, compressive properties, stiffness, flexural fatigue, and other flexural properties.
SIGNIFICANCE AND USE
X1.2 Significance
X1.2.1 Concentrations of trace metals are measured as extracts in simulated body fluids. The metal’s concentration in extracts is based on the surface area of the plastic extracted from which the total amount of metal deliverable to the patient may be estimated.
SCOPE
1.1 This specification covers polyethylene plastics (as defined in Terminology D883) intended for use in medical device applications involving human tissue contact devices, short-term indwellings of 30 days or less, and fluid transfer devices. The biocompatibility of these materials as a class has not been established. Biocompatibility tests must be conducted on the final product.
1.2 This specification is not applicable to ultra-high molecular weight polyethylenes (UHMWPE) plastics, such as those used in joint implants, and so forth.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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SIGNIFICANCE AND USE
4.1 This guide is intended to aid device fabricators in the selection of proper commercially available polyurethane solids and solutions for their application.
4.2 The polyurethanes covered by this guide may be thermoformed or solution cast into biomedical devices for use as surgical aids or for implantation as determined to be appropriate, based on supporting biocompatibility and physical test data.
SCOPE
1.1 This guide covers the evaluation of thermoplastic polyurethanes in both solid and solution form for biomedical applications. The polymers have been reacted to completion and require no further chemical processing.
1.2 The tests and methods listed in this guide may be referenced in specifications containing minimum required values and tolerances for specific end-use products.
1.3 Standard tests for biocompatibility are included to aid in the assessment of safe utilization in biomedical applications. Compliance with these criteria shall not be construed as an endorsement of implantability. Since many compositions, formulations, and forms of thermoplastic polyurethanes in solid and solution forms are within this material class, the formulator or fabricator must evaluate the biocompatibility of the specific composition or form in the intended use and after completion of all manufacturing processes including sterilization.
1.4 Purchase specifications may be prepared by agreement between the buyer and seller by selection of appropriate tests and methods from those listed applicable to the specific biomedical end use.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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This document specifies terminology, requirements and test methods for electrically operated medical refrigerating appliances as defined in 3.2 intended for the cold storage of blood components, biological specimen, vaccines, medicines, reagents, or other laboratory preparations used in medical practice and research.
This document applies to medical refrigerating appliances equipped with a remote or integrated compression-type refrigerating system.
This document covers construction characteristics relevant for the thermal and energy performance.
This document covers characteristics of LN2 cryogenic freezers but does not provide test methods.
This document does not cover hygienic and safety aspects and ergonomic principles.
NOTE Examples of standards for safety requirements applicable to medical refrigerating appliances are EN IEC 60335-1 and EN IEC 60335-2-89 or EN 61010-1 and EN IEC 61010-2-011.
This document is not applicable to:
- refrigerated incubators;
- refrigerated cells and refrigerated containers > 2 000 l;
- equipment that rely only on passive cooling;
- appliances for which the primary function is other than cold storage;
- appliances intended for short term storage;
- appliances intended for fully or partially off-grid operation.
- Draft40 pagesEnglish languagee-Library read for1 day
This document specifies terminology, requirements and test methods for electrically operated medical refrigerating appliances as defined in 3.2 intended for the cold storage of blood components, biological specimen, vaccines, medicines, reagents, or other laboratory preparations used in medical practice and research.
This document applies to medical refrigerating appliances equipped with a remote or integrated compression-type refrigerating system.
This document covers construction characteristics relevant for the thermal and energy performance.
This document covers characteristics of LN2 cryogenic freezers but does not provide test methods.
This document does not cover hygienic and safety aspects and ergonomic principles.
NOTE Examples of standards for safety requirements applicable to medical refrigerating appliances are EN IEC 60335-1 and EN IEC 60335-2-89 or EN 61010-1 and EN IEC 61010-2-011.
This document is not applicable to:
- refrigerated incubators;
- refrigerated cells and refrigerated containers > 2 000 l;
- equipment that rely only on passive cooling;
- appliances for which the primary function is other than cold storage;
- appliances intended for short term storage;
- appliances intended for fully or partially off-grid operation.
- Draft40 pagesEnglish languagee-Library read for1 day
This document specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test.
This document does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.
- Standard52 pagesEnglish languagee-Library read for1 day
- Standard52 pagesEnglish languagee-Library read for1 day
ISO 22442-1:2015 applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It specifies, in conjunction with ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control. Furthermore, it outlines the decision process for the residual risk acceptability, taking into account the balance of residual risk, as defined in ISO 14971, and expected medical benefit as compared to available alternatives. This part of ISO 22442 is intended to provide requirements and guidance on risk management related to the hazards typical of medical devices manufactured utilizing animal tissues or derivatives such as
a) contamination by bacteria, moulds or yeasts;
b) contamination by viruses;
c) contamination by agents causing Transmissible Spongiform Encephalopathies (TSE);
d) material responsible for undesired pyrogenic, immunological or toxicological reactions.
For parasites and other unclassified pathogenic entities, similar principles can apply.
ISO 22442-1:2015 does not stipulate levels of acceptability which, because they are determined by a multiplicity of factors, cannot be set down in such an International Standard except for some particular derivatives mentioned in Annex C. Annex C stipulates levels of TSE risk acceptability for tallow derivatives, animal charcoal, milk and milk derivatives, wool derivatives and amino acids.
ISO 22442-1:2015 does not specify a quality management system for the control of all stages of production of medical devices.
ISO 22442-1:2015 does not cover the utilization of human tissues in medical devices.
NOTE 1 It is not a requirement of this part of ISO 22442 to have a full quality management system during manufacture. However, attention is drawn to International Standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices.
NOTE 2 For guidance on the application of this part of ISO 22442, see Annex A.
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ISO 22442-2:2015 specifies requirements for controls on the sourcing, collection, and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin other than in vitro diagnostic medical devices. It applies where required by the risk management process as described in ISO 22442‑1.
NOTE 1 Selective sourcing is considered to be especially important for transmissible spongiform encephalopathy (TSE) risk management.
The manufacturers should refer to ISO 22442‑3 for information on the validation of the elimination and/or inactivation of viruses and TSE agents.
ISO 22442-2:2015 does not cover the utilization of human tissues in medical devices.
ISO 22442-2:2015 does not specify a quality management system for the control of all stages of production of medical devices.
It is not a requirement of this part of ISO 22442 to have a full quality management system during manufacture, but it does specify requirements for some of the elements of a quality management system. Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices. The quality management system elements that are required by this part of ISO 22442 can form a part of a quality management system conforming to ISO 13485.
NOTE 2 A general principle for the application of this International Standard is that it is advisable to give due consideration to the requirements and recommendations contained in all three parts of the standard.
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ISO 7405:2008 specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test. ISO 7405:2008 does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.
- Amendment7 pagesEnglish languagee-Library read for1 day
SIGNIFICANCE AND USE
4.1 The composition and sequential structure of alginate determines the functionality of alginate in an application. For instance, the gelling properties of an alginate are highly dependent upon the monomer composition and sequential structure of the polymer. Gel strength will depend upon the guluronic acid content (FG) and also the average number of consecutive guluronate moieties in G-block structures (NG>1).
4.2 Chemical composition and sequential structure of alginate can be determined by 1H- and 13C-nuclear magnetic resonance spectroscopy (NMR). A general description of NMR can be found in of the USP 35-NF30. The NMR methodology and assignments are based on data published by Grasdalen et al. (1979, 1981, 1983).4, 5, 6 The NMR technique has made it possible to determine the monad frequencies FM (fraction of mannuronate units) and FG (fraction of guluronate units), the four nearest neighboring (diad) frequencies FGG, FMG, FGM, FMM, and the eight next nearest neighboring (triad) frequencies FGGG, FGGM, FMGG, FMGM, FMMM, FMMG, FGMM, FGMG. Knowledge of these frequencies enables number averages of block lengths to be calculated. NG is the number average length of G-blocks, and NG>1 is the number average length of G-blocks from which singlets (-MGM-) have been excluded. Similarly, NM is the number average length of M-blocks, and NM>1 is the number average length of M-blocks from which singlets (-GMG-) have been excluded. 13C NMR must be used to determine the M-centered triads and NM>1. This test method describes only the 1H NMR analysis of alginate. Alginate can be well characterized by determining FG and NG>1.
4.3 In order to obtain well-resolved NMR spectra, it is necessary to reduce the viscosity and increase the mobility of the molecules by depolymerization of alginate to a degree of polymerization of about 20 to 50. Acid hydrolysis is used to depolymerize the alginate samples. Freeze-drying, followed by dissolution in 99 % D2O, and another freeze-drying b...
SCOPE
1.1 This test method covers the determination of the composition and monomer sequence of alginate intended for use in biomedical and pharmaceutical applications as well as in Tissue Engineered Medical Products (TEMPs) by high-resolution proton NMR (1H NMR). A guide for the characterization of alginate has been published as Guide F2064.
1.2 Alginate, a linear polymer composed of β-D-mannuronate (M) and its C-5 epimer α-L-guluronate (G) linked by β-(1—>4) glycosidic bonds, is characterized by calculating parameters such as mannuronate/guluronate (M/G) ratio, guluronic acid content (G-content), and average length of blocks of consecutive G monomers (that is, NG>1 ). Knowledge of these parameters is important for an understanding of the functionality of alginate in TEMP formulations and applications. This test method will assist end users in choosing the correct alginate for their particular application. Alginate may have utility as a scaffold or matrix material for TEMPs, in cell and tissue encapsulation applications, and in drug delivery formulations.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
WITHDRAWN RATIONALE
This test method covered the determination of the composition and monomer sequence of alginate intended for use in biomedical and pharmaceutical applications as well as in Tissue Engineered Medical Products (TEMPs) by high-resolution proton NMR (1H NMR).
Formerly under the jurisdiction of Committee F04 on Medical and Surgical Materials and Devices, this test method was withdrawn in July 2021 in accordance with section 10.6.3 of the Regu...
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