11.100.01 - Laboratory medicine in general
ICS 11.100.01 Details
Laboratory medicine in general
Médecine de laboratoire en général
Laboratorijska medicina na splošno
General Information
Frequently Asked Questions
ICS 11.100.01 is a classification code in the International Classification for Standards (ICS) system. It covers "Laboratory medicine in general". 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 84 standards classified under ICS 11.100.01 (Laboratory medicine in general). 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.
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This document defines the core terms and definitions in the field of laboratory design.
- Standard30 pagesEnglish languagesale 15% off
- Draft38 pagesFrench languagesale 15% off
This document establishes requirements for assuring quality, safety, performance and documentation of laboratory-developed tests (LDTs) as per their intended use for the diagnosis, prognosis, monitoring, prevention or treatment of medical conditions.
It outlines the general principles and assessment criteria by which an LDT shall be designed, developed, characterized, manufactured, validated (analytically and clinically) and monitored for internal use by medical laboratories.
The scope includes regulatory authority approved IVD medical devices that are used in a manner differing from approved labelling or instructions for use for that device (e.g. use of a sample type not included in the intended use, use of instruments or reagents not included in the labelling).
While this document follows a current best practice and state-of-the art approach, it does not provide specific details on how to achieve these requirements within specific disciplines of the medical laboratory nor specific technology platforms.
This document does not specify requirements for examination procedures developed by research or academic laboratories developing and using testing systems for non-IVD purposes. However, the concepts presented in this document can also be useful for these laboratories.
This document does not apply to the design, development and industrial production of commercially used IVD medical devices.
- Standard43 pagesEnglish languagee-Library read for1 day
This document provides requirements and recommendations for supervisors and operators of point-of-care testing (POCT) services where POCT is performed without medical laboratory training, supervision or support. It includes the key components that should be considered to provide safe and reliable POCT results. Self-testing is excluded from this document.
- Technical specification33 pagesEnglish languagesale 15% off
- Technical specification38 pagesSpanish languagesale 15% off
This document provides guidance to anatomic pathology (AP) laboratories on implementing a management system to meet requirements for quality and competence of ISO 15189. NOTE International, national, or regional regulations or requirements can also apply to specific topics covered in this document.
- Technical specification31 pagesEnglish languagesale 15% off
- Technical specification34 pagesSpanish languagesale 15% off
This document defines the requirements for competence of individuals who provide advice, guidance, and assurance on processes to identify, assess, control, and monitor the risks associated with hazardous biological materials in a laboratory or other related organization that handles, stores, transports, or disposes of biological materials that can be potentially hazardous for people, animals, plants and the environment.
- Technical specification62 pagesEnglish languagesale 15% off
- Technical specification68 pagesSpanish languagesale 15% off
- Standard1 pageEnglish languagesale 15% off
- Standard1 pageFrench languagesale 15% off
- Standard1 pageFrench languagesale 15% off
- Amendment4 pagesEnglish languagee-Library read for1 day
- Amendment4 pagesEnglish languagee-Library read for1 day
- Amendment4 pagesEnglish languagee-Library read for1 day
- Amendment4 pagesEnglish languagee-Library read for1 day
This document specifies requirements and good practice recommendations for the collection and transport of samples intended for medical laboratory examinations. This document is applicable to medical laboratories and service providers, which can be independent from the medical laboratory, involved in laboratory pre-examination processes that include the examination request, patient preparation and identification, sample collection and transport. It can also be applicable to some biobanks. This document does not apply to blood and blood products intended for transfusion, e.g. red blood cells, platelets, fresh frozen plasma, but can cover the collection and transport of donor samples for testing. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
- Standard42 pagesEnglish languagesale 15% off
- Standard47 pagesFrench languagesale 15% off
This document specifies requirements and tests for glass Petri dishes intended for general laboratory purposes and microbiological work.
- Standard7 pagesEnglish languagesale 15% off
- Standard7 pagesFrench languagesale 15% off
This document specifies requirements for quality and competence in medical laboratories.
This document is applicable to medical laboratories in developing their management systems and assessing their competence. It is also applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies.
This document is also applicable to point-of-care testing (POCT).
NOTE International, national, or regional regulations or requirements can also apply to specific topics covered in this document.
- Standard72 pagesEnglish languagee-Library read for1 day
- Standard – translation102 pagesSlovenian and English languagee-Library read for1 day
SIGNIFICANCE AND USE
5.1 The protocols that exist for photographing a decedent’s face at autopsy for identification purposes (for example, NAME Forensic Autopsy Performance Standards) do not always result in the capture of facial images that can be used for automated FR searches or manual facial comparisons. It is not always feasible to collect fingerprints from decedents (for example, in disaster situations or when a decedent is in a state of advanced decomposition), and radiograph (medical or dental) comparison requires at least a presumptive identification of remains so appropriate comparative antemortem radiographs can be obtained to confirm the identification. If the decedent’s DNA or appropriate family reference DNA profiles are not already stored within a DNA repository (for example, the FBI’s CODIS), a DNA association will also require the presumptive identification of a decedent to ensure that appropriate samples are collected for comparison/association.
5.2 It is advisable to follow the guidelines presented in this guide even when not all facial components are present as even incomplete facial images can assist automated FR and manual facial comparison processes, especially through more accurate recording of minute facial details.
5.3 For the purpose of facial image capture, there are various perimortem or postmortem conditions or both that can degrade the usability of any facial images captured:
5.3.1 Presence of trauma (for example, entry/exit wounds, lacerations, bruising, missing components, etc.),
5.3.2 Obscuring matter (for example, blood, fluids, dirt, debris, hair, clothing accessories, and so forth), and
5.3.3 Decomposition and other postmortem changes (for example, bloating, mummification, skeletonization, evidence of insect or scavenger activity, etc.).
5.4 Before any attempt is made to clean or alter the decedent for facial image capture, nationally accepted standards or agency protocols or both should be followed so the alterations do not affect ...
SCOPE
1.1 The purpose of this document is to provide guidelines for capturing postmortem facial images of human remains in controlled (for example, morgue) and semi-controlled (for example, field) settings to facilitate automated facial recognition (FR) searches or manual facial comparisons that could contribute to forensic investigations.
1.2 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.
1.3 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.
- Guide7 pagesEnglish languagesale 15% off
This document provides requirements and recommendations for the design, development, verification, validation and implementation of analytical tests for detecting the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using nucleic acid amplification. It addresses pre-examination, examination and post-examination process steps for human specimens.
This document is applicable to medical laboratories. It is also intended to be used by in vitro diagnostic developers and manufacturers, as well as by institutions and organizations supporting SARS-CoV-2 research and diagnostics.
This document does not apply to environmental samples.
- Technical specification53 pagesEnglish languagee-Library read for1 day
This document specifies requirements for quality and competence in medical laboratories.
This document is applicable to medical laboratories in developing their management systems and assessing their competence. It is also applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies.
This document is also applicable to point-of-care testing (POCT).
NOTE International, national, or regional regulations or requirements can also apply to specific topics covered in this document.
- Standard72 pagesEnglish languagee-Library read for1 day
- Standard – translation102 pagesSlovenian and English languagee-Library read for1 day
This document specifies requirements for quality and competence in medical laboratories. This document is applicable to medical laboratories in developing their management systems and assessing their competence. It is also applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies. This document is also applicable to point-of-care testing (POCT). NOTE International, national, or regional regulations or requirements can also apply to specific topics covered in this document.
- Standard69 pagesEnglish languagee-Library read for1 day
- Standard62 pagesEnglish languagesale 15% off
- Standard66 pagesFrench languagesale 15% off
- Standard66 pagesFrench languagesale 15% off
- Standard66 pagesFrench languagesale 15% off
- Standard64 pagesEnglish, Spanish and Russian languagesale 15% off
This document provides requirements and recommendations for the design, development, verification, validation and implementation of analytical tests for detecting the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using nucleic acid amplification. It addresses pre-examination, examination and post-examination process steps for human specimens.
This document is applicable to medical laboratories. It is also intended to be used by in vitro diagnostic developers and manufacturers, as well as by institutions and organizations supporting SARS-CoV-2 research and diagnostics.
This document does not apply to environmental samples.
- Technical specification53 pagesEnglish languagee-Library read for1 day
SIGNIFICANCE AND USE
5.1 The term duckweed commonly refers to members of the family Lemnaceae. This family has many species world-wide in 4 genera. This guide is designed for toxicity testing with one particular clone of one species of duckweed that has been extensively studied, Lemna gibba G3, although other species such as Lemna minor or Spirodela spp. can probably also be tested using the procedures described herein.
5.2 Duckweeds are widespread, free-floating aquatic plants, ranging in the world from tropical to temperate zones. Duckweeds are a source of food for waterfowl and small animals and provide food, shelter, and shade for fish. The plants also serve as physical support for a variety of small invertebrates. Duckweed is fast growing and reproduces rapidly compared with other vascular plants (1).3 Under conditions favorable for its growth, it can multiply quickly and form a dense mat in lakes, ponds, and canals, primarily in fresh water, but also in estuaries. It also grows well in effluents of wastewater treatment plants and has been suggested as a means of treating wastewaters (2). A dense mat of duckweed can block sunlight and aeration and cause fish kills (3).
5.3 Duckweed is small enough that large laboratory facilities are not necessary, but large enough that effects can be observed visually.
5.4 Because duckweed is a floating macrophyte, it might be particularly susceptible to surface active and hydrophobic chemicals that concentrate at the air-water interface. Results of duckweed tests on such chemicals, therefore, might be substantially different from those obtained with other aquatic species.
5.5 Results of toxicity tests with duckweed might be used to predict effects likely to occur on duckweed in field situations as a result of exposure under comparable conditions.
5.6 Results of tests with duckweed might be used to compare the toxicities of different materials and to study the effects of various environmental factors on results of such tests.
5.7...
SCOPE
1.1 This guide describes procedures for obtaining laboratory data concerning the adverse effects of a text material added to growth medium on a certain species of duckweed (Lemna gibba G3) during a 7-day exposure using the static technique. These procedures will probably be useful for conducting toxicity tests with other species of duckweed and other floating vascular plants, although modifications might be necessary.
1.2 Special needs or circumstances might also justify modification of this standard. Although using appropriate procedures is more important than following prescribed procedures, results of tests conducted using unusual procedures are not likely to be comparable to results of many other tests. Comparison of results obtained using modified and unmodified versions of these procedures might provide useful information concerning new concepts and procedures for conducting tests with duckweed.
1.3 The procedures in this guide are applicable to most chemicals, either individually or in formulations, commercial products, or known mixtures. With appropriate modifications these procedures can be used to conduct tests on temperature and pH and on such other materials as aqueous effluents (see also Guide E1192), leachates, oils, particulate matter, sediments and surface waters. These procedures do not specifically address effluents because to date there is little experience using duckweeds in effluent testing and such tests may pose problems with acclimation of the test organisms to the receiving water. Static tests might not be applicable to materials that have a high oxygen demand, are highly volatile, are rapidly biologically or chemically transformed in aqueous solution, or are removed from test solutions in substantial quantities by the test chambers or organisms during the test.
1.4 Results of toxicity tests performed using the procedures in this guide should usually be reported in terms of the 7-day IC5...
- Guide11 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
5.1 This test method is one of a series of tests listed in Practice F748 and ISO 10993-4 to assess the biocompatibility of materials contacting blood in medical applications.
5.2 This test method is similar to Practice F756 but modified to accommodate nanoparticulate materials.
SCOPE
1.1 This test method covers assessing the effect of nanoparticulate materials on the integrity of red blood cells.
1.2 This test method uses diluted whole blood incubated with nanoparticulate material and the hemoglobin released from damaged red blood cells is determined.
1.3 This test method is similar to Practice F756 with the volumes reduced to accommodate nanoparticulate material.
1.4 This test method is part of the in-vitro preclinical characterization and is important for nanoparticulate material that will contact the blood in medical applications.
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.
- Standard6 pagesEnglish languagesale 15% off
This document provides requirements and recommendations for the design, development, verification, validation and implementation of analytical tests for detecting the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using nucleic acid amplification. It addresses pre-examination, examination and post-examination process steps for human specimens. This document is applicable to medical laboratories. It is also intended to be used by in vitro diagnostic developers and manufacturers, as well as by institutions and organizations supporting SARS-CoV-2 research and diagnostics. This document does not apply to environmental samples.
- Technical specification44 pagesEnglish languagesale 15% off
- Technical specification48 pagesFrench languagesale 15% off
- Technical specification48 pagesFrench languagesale 15% off
This document specifies the minimum requirements for equipment and critical aspects of the test methods for best practice in laboratories performing basic examination of human semen collected by ejaculation.
This document is applicable to the entire process of basic manual semen examination and also to sample preparation for Computer-Aided Sperm Analysis (CASA).
This document does not apply to the post-vasectomy assessments.
NOTE Given the medico-legal ramifications surrounding the evaluation of post-vasectomy ejaculates, the methodology in this document is in all likelihood inadequate to establish an ejaculate as being completely “clear” (i.e. no spermatozoa in the ejaculate).
- Standard41 pagesEnglish languagee-Library read for1 day
This document specifies the minimum requirements for equipment and critical aspects of the test methods for best practice in laboratories performing basic examination of human semen collected by ejaculation.
This document is applicable to the entire process of basic manual semen examination and also to sample preparation for Computer-Aided Sperm Analysis (CASA).
This document does not apply to the post-vasectomy assessments.
NOTE Given the medico-legal ramifications surrounding the evaluation of post-vasectomy ejaculates, the methodology in this document is in all likelihood inadequate to establish an ejaculate as being completely “clear” (i.e. no spermatozoa in the ejaculate).
- Standard41 pagesEnglish languagee-Library read for1 day
This document specifies the minimum requirements for equipment and critical aspects of the test methods for best practice in laboratories performing basic examination of human semen collected by ejaculation. This document is applicable to the entire process of basic manual semen examination and also to sample preparation for Computer-Aided Sperm Analysis (CASA). This document does not apply to the post-vasectomy assessments. NOTE Given the medico-legal ramifications surrounding the evaluation of post-vasectomy ejaculates, the methodology in this document is in all likelihood inadequate to establish an ejaculate as being completely “clear” (i.e. no spermatozoa in the ejaculate).
- Standard32 pagesEnglish languagesale 15% off
- Standard34 pagesFrench languagesale 15% off
- Standard34 pagesEnglish, Spanish and Russian languagesale 15% off
This document specifies requirements and gives recommendations for the pre-examination phase of human specimens, such as stool, saliva, skin and urogenital specimens, intended for microbiome DNA examination. The pre-examination phase includes but is not limited to specimen collection, handling, transport, storage, processing, isolation of DNA, and documentation.
This document is applicable to molecular in vitro diagnostic examinations performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.
Different dedicated measures are taken for pre-examination processes for infectious disease examination (e.g. targeted pathogen identification) and for microbiome DNA examination from tissue (e.g. biopsies). These are outside of the scope of this document.
Different dedicated measures are taken for pre-examination processes for saliva for human genomic DNA examination. These are not described in this document but are covered in CEN/TS 17305, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated DNA.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
- Technical specification38 pagesEnglish languagee-Library read for1 day
This document specifies requirements and gives recommendations for the pre-examination phase of human specimens, such as stool, saliva, skin and urogenital specimens, intended for microbiome DNA examination. The pre-examination phase includes but is not limited to specimen collection, handling, transport, storage, processing, isolation of DNA, and documentation.
This document is applicable to molecular in vitro diagnostic examinations performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.
Different dedicated measures are taken for pre-examination processes for infectious disease examination (e.g. targeted pathogen identification) and for microbiome DNA examination from tissue (e.g. biopsies). These are outside of the scope of this document.
Different dedicated measures are taken for pre-examination processes for saliva for human genomic DNA examination. These are not described in this document but are covered in CEN/TS 17305, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated DNA.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
- Technical specification38 pagesEnglish languagee-Library read for1 day
SIGNIFICANCE AND USE
5.1 This guide can be used to evaluate the performance of a laboratory or group of laboratories participating in a proficiency test (PT) program involving petroleum and petroleum products.
5.2 Data accrued, using the techniques included in this guide, provide the ability to monitor analytical measurement system precision and bias. These data are useful for updating standard test methods, as well as for indicating areas of potential measurement system improvement for action by the laboratory. This guide serves both the individual participating laboratory and the responsible standards development group as follows:
5.2.1 Tools and Approaches for Participating Laboratories.
Administrative Reviews
Flagged Data and Investigations
Data Normality Checks
QQ Plots
Histograms
Bias (Deviation from Mean)
Run-Sum
Z-Scores, Z′-Scores Trends
Precision Performance—TPIIND, F-test
Comparison of PTP and Individual Laboratory Site Precision
5.2.2 Tools and Approaches for Responsible Standards Development Groups.
TPI and precision trends
Bias and precision comparisons via box & whisker plots
Normality evaluations
Relative standard deviations
Uncontrolled variables
5.3 Reference is made in this guide to the ASTM International Proficiency Test Program on Petroleum Products, Liquid Fuels, and Lubricants, version PTP 2.0 implemented in 2016–2017. Program reports containing similarly displayed results and statistical treatments may be available in other PT programs. Appendix X2 summarizes the statistical tools referenced in this guide and Appendix X3 is a collection of examples covering QQ plots, histograms, and Run-Sum described in this guide.
SCOPE
1.1 This guide covers the evaluation and interpretation of proficiency test program (PTP) results. For proficiency test program participants, this guide describes procedures for assessing participants’ results relative to the collective PT program results and potentially improving the laboratory’s testing performance based on the assessment of findings and insights. For the committees responsible for the test methods included in PT programs, this guide describes procedures for assessing industry’s ability to perform test methods and for potentially identifying opportunities for improvements.
1.2 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.
1.3 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.
- Guide17 pagesEnglish languagesale 15% off
- Guide17 pagesEnglish languagesale 15% off
This document describes the particular clinical laboratory practice requirements to ensure the quality of detection, identification and quantification of microbial pathogens using nucleic acid amplification tests (NAAT). It is intended for use by laboratories that develop, and/or implement and use, or perform NAAT for medical, research or health-related purposes. This document does not apply to the development of in vitro diagnostic (IVD) medical devices by manufacturers. However, it does include verification and validation of such devices and/or the corresponding processes when implemented and used by the laboratories.
- Standard39 pagesEnglish languagesale 15% off
- Standard39 pagesEnglish languagesale 15% off
This document specifies a process for a medical laboratory to identify and manage the risks to patients, laboratory workers and service providers that are associated with medical laboratory examinations. The process includes identifying, estimating, evaluating, controlling and monitoring the risks.
The requirements of this document are applicable to all aspects of the examinations and services of a medical laboratory, including the pre-examination and post-examination aspects, examinations, accurate transmission of test results into the electronic medical record and other technical and management processes described in ISO 15189.
This document does not specify acceptable levels of risk.
This document does not apply to risks from post-examination clinical decisions made by healthcare providers.
This document does not apply to the management of risks affecting medical laboratory enterprises that are addressed by ISO 31000, such as business, economic, legal, and regulatory risks.
- Standard91 pagesEnglish languagee-Library read for1 day
- Standard91 pagesEnglish languagee-Library read for1 day
This document specifies a process for a medical laboratory to identify and manage the risks to patients, laboratory workers and service providers that are associated with medical laboratory examinations. The process includes identifying, estimating, evaluating, controlling and monitoring the risks.
The requirements of this document are applicable to all aspects of the examinations and services of a medical laboratory, including the pre-examination and post-examination aspects, examinations, accurate transmission of test results into the electronic medical record and other technical and management processes described in ISO 15189.
This document does not specify acceptable levels of risk.
This document does not apply to risks from post-examination clinical decisions made by healthcare providers.
This document does not apply to the management of risks affecting medical laboratory enterprises that are addressed by ISO 31000, such as business, economic, legal, and regulatory risks.
- Standard91 pagesEnglish languagee-Library read for1 day
- Standard91 pagesEnglish languagee-Library read for1 day
This document specifies a process for a medical laboratory to identify and manage the risks to patients, laboratory workers and service providers that are associated with medical laboratory examinations. The process includes identifying, estimating, evaluating, controlling and monitoring the risks. The requirements of this document are applicable to all aspects of the examinations and services of a medical laboratory, including the pre-examination and post-examination aspects, examinations, accurate transmission of test results into the electronic medical record and other technical and management processes described in ISO 15189. This document does not specify acceptable levels of risk. This document does not apply to risks from post-examination clinical decisions made by healthcare providers. This document does not apply to the management of risks affecting medical laboratory enterprises that are addressed by ISO 31000, such as business, economic, legal, and regulatory risks.
- Standard82 pagesEnglish languagesale 15% off
- Standard87 pagesFrench languagesale 15% off
- Standard86 pagesEnglish, Spanish and Russian languagesale 15% off
This document specifies requirements for safe practices in the medical laboratory (herein after referred to as "the laboratory").
- Standard79 pagesEnglish languagesale 15% off
- Standard84 pagesSpanish languagesale 15% off
- Standard80 pagesSpanish languagesale 15% off
This document gives guidance for supervisors and operators of point-of-care testing (POCT) services where POCT is performed without medical laboratory training, supervision or support. It includes the key components that should be considered to provide safe and reliable POCT results. Self-testing is excluded from this document.
- Technical specification35 pagesEnglish languagesale 15% off
This document defines a process to identify, assess, control, and monitor the risks associated with hazardous biological materials. This document is applicable to any laboratory or other organization that works with, stores, transports, and/or disposes of hazardous biological materials. This document is intended to complement existing International Standards for laboratories. This document is not intended for laboratories that test for the presence of microorganisms and/or toxins in food or feedstuffs. This document is not intended for the management of risks from the use of genetically modified crops in agriculture.
- Standard26 pagesEnglish languagesale 15% off
- Standard27 pagesFrench languagesale 15% off
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- Standard26 pagesSpanish languagesale 15% off
SIGNIFICANCE AND USE
5.1 A risk-based approach must be used to determine the cell lines, test articles, and materials used for testing. An evaluation of relevant factors should be made to determine if a test article is representative of the intended use.
5.2 Cell culture compatibility should be assessed if the material is in direct contact with cell culture medium regardless of duration of contact. Test articles can be of a single material or assembled from a multitude of materials.
5.3 Two perspectives to single-use material cell culture compatibility assessments are the supplier and the end user perspectives. It is understood that the supplier may have better access to single-use materials and material manufacturing processes, while having limited access to representative cell lines. Supplier assessment of materials are best tested using cell lines available that have shown known material sensitivity. The end users may have more limited access to materials but access to more representative cell lines and processes. Therefore assessment of compatibility of material with a specific cell line in a process is best evaluated by the end user.
5.4 This guide outlines best practices to establish test procedures. Appendix X1 outlines an example test procedure for a commercially available CHO cell line.
SCOPE
1.1 This guide outlines best practices to consider when setting up a representative leachable test method to detect if a material is compatible with cell culture media or manufacturing processes. This guide does not replace or supersede cell growth tests like USP , USP (plastic/elastomeric materials), or ISO 10993 (medical device materials), that are used in assessing biological reactivity in humans. Polymeric materials that have passed these tests have been found to leach compounds under normal process conditions that can inhibit cell culture growth for some cell lines. See Refs (1-5).2 Test methods that are representative of the manufacturing conditions will help identify materials that are appropriate for use during manufacturing.
1.2 This guide may be relevant to biopharmaceutical manufacturing, cell-based therapeutics, vaccines, cell-based diagnostics, and other areas.
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.
- Guide6 pagesEnglish languagesale 15% off
This document provides practical guidance for the estimation and expression of the measurement uncertainty (MU) of quantitative measurand values produced by medical laboratories. Quantitative measurand values produced near the medical decision threshold by point-of-care testing systems are also included in this scope. This document also applies to the estimation of MU for results produced by qualitative (nominal) methods which include a measurement step. It is not recommended that estimates of MU be routinely reported with patient test results, but should be available on request. NOTE See Annex B for an example of application of the MU.
- Technical specification73 pagesEnglish languagesale 15% off
- Technical specification77 pagesFrench 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
SIGNIFICANCE AND USE
4.1 This guide is designed to assist medical device manufacturers as they develop new devices or qualify existing devices (e.g., catheters, needles) for delivering clinical cell therapies. Cytocompatibility considers the impact of the delivery device on the cells passing through the device during the delivery procedure. The biological safety of the device (e.g., the device’s cytotoxicity) should be addressed via other methods, such as ISO 10993-5. It is understood that this guide does not address testing of specific cellular products with specific delivery devices. Such testing may be required by regulatory authorities prior to clinical trial of cellular product or marketing applications. This guide outlines considerations to make the product qualification procedures more likely to succeed and more cost effective.
4.2 The key aspects of assessing device cytocompatibility include selecting a test cell line or cell lines and determining the cell physiology parameters that will be measured to make a determination of cytocompatibility. Acceptance criteria for designating a device as cytocompatible are not detailed here. It will be up to the delivery device end user to determine if the results of a cytocompatibility assessment are sufficient to consider that device cytocompatible. Delivery device lot to lot variability may impact cytocompatibility, therefore validated manufacturing processes should be considered when producing devices for cytocompatibility assessments.
SCOPE
1.1 This guide outlines the parameters to consider when designing in vitro tests to assess the potential impact of a delivery device on a cellular product being dispensed. This guide does not provide specific protocols, but rather suggests what should be considered the minimum characterization necessary to assess device cytocompatibility. Topics discussed include selecting an appropriate cell line(s), cell physiology parameters to measure, and relevant test procedure variables. Only cells suspended in liquid and infused through a device are considered. Cell therapies paired with scaffolds, suspended in hydrogels, or administered via other methods (e.g., tissue grafting) are not included in the scope of this document. This document does not address physical characterization of delivery devices, such as mechanics, composition, or degradation.
1.2 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.
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.
- Guide4 pagesEnglish languagesale 15% off
ISO/TS 17518:2015 provides requirements and guidance for selecting and assessing the quality of reagents to be used for in vitro diagnostic staining in biology. This Technical Specification applies to the professional use of reagents for staining in biology by medical laboratories, and in particular, to those who are responsible for the requisition and evaluation of these reagents in medical laboratory disciplines such as clinical cytology, haematology, histopathology, microbiology, and molecular biology.
- Technical specification15 pagesEnglish languagesale 15% off
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ISO 13130:2011 specifies requirements and tests for desiccators and vacuum desiccators intended for general laboratory purposes such as drying of substances or material.
- Standard13 pagesEnglish languagee-Library read for1 day
ISO 13130:2011 specifies requirements and tests for desiccators and vacuum desiccators intended for general laboratory purposes such as drying of substances or material.
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ISO 24998:2008 specifies requirements and test methods for plain, single-use Petri dishes for microbiological use. ISO 24998:2008 does not apply to products of similar design which may be used for cell or tissue culture purposes. Neither does it apply to dishes supplied ready loaded with microbiological media.
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This European Standard, in order to protect the worker and/or the environment, gives guidance on minimum physical biosafety measures for the containment of animals deliberately inoculated with microorganisms, including genetically modified microorganisms, which can present a risk to human or animal health or the environment. This European Standard does not apply to the containment of animals which have not been deliberately inoculated with microorganisms.
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This European Standard gives guidance for practice for biotechnology operations in research, development and analysis laboratories of containment levels 1, 2, 3 and 4 (see EN 12128 and prEN 12738). This European Standard aims at the protection of workers from biological hazards as well as the environment including plants and animals.
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Flow-out and blow-out pipettes are considered. They will only be expected to provide their specified performance during the original operation. The requirements deal with the basis of adjustment, dimensions, delivery time and construction. The determination of accuracy and repeatability and the marking are specified.
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This document specifies a process for a medical laboratory to identify and manage the risks to patients, laboratory workers and service providers that are associated with medical laboratory examinations. The process includes identifying, estimating, evaluating, controlling and monitoring the risks.
The requirements of this document are applicable to all aspects of the examinations and services of a medical laboratory, including the pre-examination and post-examination aspects, examinations, accurate transmission of test results into the electronic medical record and other technical and management processes described in ISO 15189.
This document does not specify acceptable levels of risk.
This document does not apply to risks from post-examination clinical decisions made by healthcare providers.
This document does not apply to the management of risks affecting medical laboratory enterprises that are addressed by ISO 31000, such as business, economic, legal, and regulatory risks.
- Draft86 pagesEnglish languagee-Library read for1 day
This document specifies a process for a medical laboratory to identify and manage the risks to patients, laboratory workers and service providers that are associated with medical laboratory examinations. The process includes identifying, estimating, evaluating, controlling and monitoring the risks.
The requirements of this document are applicable to all aspects of the examinations and services of a medical laboratory, including the pre-examination and post-examination aspects, examinations, accurate transmission of test results into the electronic medical record and other technical and management processes described in ISO 15189.
This document does not specify acceptable levels of risk.
This document does not apply to risks from post-examination clinical decisions made by healthcare providers.
This document does not apply to the management of risks affecting medical laboratory enterprises that are addressed by ISO 31000, such as business, economic, legal, and regulatory risks.
- Draft86 pagesEnglish languagee-Library read for1 day
This ISO Technical Specification provides detailed guidance on the implementation of the biorisk management elements outlined in ISO 35001 “Biorisk management for laboratories and other related organisations.” This document leverages the expired CEN Workshop Agreement 16393:2012 Guidance for the Implementation of CWA 15793:2008. (CEN Workshop Agreement 15793:2011 “Laboratory Biorisk Management” – the basis for ISO 35001). This document is intended to complement existing International Standards for laboratories and related facilities including ISO 35001:2019. Implementation guidance to explain what is written in and support action to materialise ISO 35001 is seriously needed, since risk assessment-based biorisk management system is relatively new to laboratories. For ISO 35001 to be implemented globally, this performance-based standard requires supportive documents providing details of how to conform with it. CWA 15793:2012 and CWA 16393:2012 will be used as a informative references for this work.
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- Draft12 pagesEnglish languagee-Library read for1 day
This document specifies a process for a medical laboratory to identify and manage the risks to patients, laboratory workers and service providers that are associated with medical laboratory examinations. The process includes identifying, estimating, evaluating, controlling and monitoring the risks. The requirements of this document are applicable to all aspects of the examinations and services of a medical laboratory, including the pre-examination and post-examination aspects, examinations, accurate transmission of test results into the electronic medical record and other technical and management processes described in ISO 15189. This document does not specify acceptable levels of risk. This document does not apply to risks from post-examination clinical decisions made by healthcare providers. This document does not apply to the management of risks affecting medical laboratory enterprises that are addressed by ISO 31000, such as business, economic, legal, and regulatory risks.
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- Draft83 pagesEnglish languagesale 15% off