11.120.20 - Wound dressings and compresses
ICS 11.120.20 Details
Wound dressings and compresses
Sanitetni materiali, obveze in komprese
General Information
Frequently Asked Questions
ICS 11.120.20 is a classification code in the International Classification for Standards (ICS) system. It covers "Wound dressings and compresses". 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 68 standards classified under ICS 11.120.20 (Wound dressings and compresses). 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 specifies minimum requirements and a test method for the antimicrobial (microbicidal or microbistatic) activity of wound dressing products. It applies to all wound dressing products that specifically claim antimicrobial activity according to this document.
- Standard47 pagesEnglish languagee-Library read for1 day
This document specifies minimum requirements and a test method for the antimicrobial (microbicidal or microbistatic) activity of wound dressing products. It applies to all wound dressing products that specifically claim antimicrobial activity according to this document.
- Standard47 pagesEnglish languagee-Library read for1 day
This document specifies test methods for the evaluation of aspects of absorption of wound dressings, test methods for the evaluation of moisture vapour transmission rate of permeable film wound and fixation dressings, and test methods to assess waterproofness and extensibility.
- Standard70 pagesEnglish languagee-Library read for1 day
SIGNIFICANCE AND USE
5.1 This test method offers a procedure for evaluating medical face mask resistance to synthetic blood penetration that is useful in establishing claims for penetration resistance performance of medical face masks and ranking their performance. However, this test method does not define acceptable levels of penetration resistance because this determination must be made by each responsible user organization based on its own specific application and conditions. Therefore, when using this test method to make claims for the performance of medical face masks, the specific conditions under which testing is conducted must be described.
5.2 Medical face masks may be intended to resist liquid penetration from the splatter or splashing of blood, body fluids, and other potentially infectious materials. Many factors affect the wetting and penetration characteristics of body fluids, such as surface tension, viscosity, and polarity of the fluid, as well as the structure and relative hydrophilicity or hydrophobicity of the materials and the design of the mask itself. The surface tension range for blood and body fluids (excluding saliva) is approximately 0.042 to 0.060 N/m.6 To help simulate the wetting characteristics of blood and body fluids, the surface tension of the synthetic blood is adjusted to approximate the lower end of this surface tension range. The resulting surface tension of the synthetic blood is 40 ± 5 dyn/cm (0.040 ± 0.005 N/m).
5.3 The synthetic blood mixture is prepared with a red dye to aid in visual detection and a thickening agent to simulate the flow characteristics of blood. The synthetic blood will not always duplicate the polarity, and thus the wetting behavior and subsequent penetration, of real blood and other body fluids through protective clothing materials.
5.4 During a medical procedure, a blood vessel is occasionally punctured, resulting in a high-velocity stream of blood impacting a protective medical face mask. The impact velocity depends...
SCOPE
1.1 This test method is used to evaluate the resistance of medical face masks to penetration by the impact of a small volume (~2 mL) of a high-velocity stream of synthetic blood. Medical face mask pass/fail determinations are based on visual detection of synthetic blood penetration.
1.2 This test method does not apply to all forms or conditions of blood-borne pathogen exposure. Users of the test method must review modes for face exposure and assess the appropriateness of this test method for their specific application.
1.3 This test method is primarily intended to address the performance of finished medical face masks. While this test method may also be used to assess performance of materials or certain material constructions used in medical face masks, it is important to note the performance of finished medical face masks may be impacted by the interaction of the materials used and how they have been assembled. Results can differ depending on testing a final finished medical face mask or materials taken from manufactured medical face masks.
1.4 This test method does not address other factors with the potential to affect the overall protection offered by the medical face mask and its operation (such as filtration efficiency and pressure drop).
1.5 This test method does not address breathability of the medical face mask materials or any other properties affecting the ease of breathing through the medical face mask. This test method evaluates medical face masks as an item of protective clothing. This test method does not evaluate the performance of medical face masks for airborne exposure pathways or in the prevention of the penetration of aerosolized body fluids deposited on the medical face mask.
1.6 The values stated in 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...
- Standard21 pagesEnglish languagesale 15% off
- Standard21 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
5.1 This test method measures the initial filtration efficiency of materials by sampling representative volumes of the upstream and downstream latex aerosol concentrations in a controlled airflow chamber.
5.2 This test method provides specific test techniques for both manufacturers and users to evaluate materials when exposed to aerosol particle sizes between 0.1 and 5.0 μm.
5.2.1 This test method establishes a basis of efficiency comparison between materials.
SCOPE
1.1 This test method establishes procedures for measuring the initial particle filtration efficiency of materials using monodispersed aerosols.
1.1.1 This test method utilizes light-scattering particle counting in the size range of 0.1 to 5.0 μm and airflow test velocities of 0.5 to 25 cm/s.
1.2 The test procedure measures filtration efficiency by comparing the particle count in the feed stream (upstream) to that in the filtrate (downstream).
1.3 The values stated in SI units or in other units shall be regarded separately as standard. The values stated in each system must be used independently of the other, without combining values in any way.
1.4 The following precautionary caveat pertains only to the test methods portion, Section 10, 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.
1.5 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.
- Standard8 pagesEnglish languagesale 15% off
- Standard8 pagesEnglish languagesale 15% off
This document specifies test methods for the evaluation of aspects of absorption of wound dressings, test methods for the evaluation of moisture vapour transmission rate of permeable film wound and fixation dressings, and test methods to assess waterproofness and extensibility.
- Standard70 pagesEnglish languagee-Library read for1 day
SIGNIFICANCE AND USE
4.1 This guide provides definitions and a classification for CTPs, as well as definitions related to skin tissue, skin wounds and ulcers, wound healing physiology, wound covers, and related medical and surgical procedures. This guide is not intended to prescribe or limit the clinical uses of these products.
4.2 One objective of the current guide is to include the wide range of CTPs for which there is a rationale for benefit beyond that achievable with conventional wound coverings. Whether an individual CTP is capable of promoting wound healing must be determined by adequate evidence and is beyond the scope of this standard. Given that some of the materials used in dressings and skin substitutes (defined in Guide F2311) are the same as those used in CTPs, there has been confusion as to how to classify these products.
4.3 This guide is distinguished from Guide F2311, which defines terminology and provides classification by clinical use for products that can be substituted for tissue grafts of human or animal tissue in medical and surgical therapies of skin lesions. In contrast, this guide defines terminology for description of CTPs for skin wounds; CTPs are defined primarily by their composition. Neither guide establishes a correspondence between device structure and clinical function.
SCOPE
1.1 This guide defines terminology for description of cellular and/or tissue-based products (CTPs) for skin wounds. CTPs are TEMPs (tissue-engineered medical products) that are primarily defined by their composition and comprise viable and/or nonviable human or animal cells, viable and/or nonviable tissues, and may include extracellular matrix components. CTPs may additionally include synthetic components.
1.2 This guide also describes categories and terminology for CTPs based on their composition. This systematic categorization is not intended to be prescriptive for product labeling, and it describes only the most salient characteristics of these products; the actual biological and clinical functions can depend on characteristics not recognized in the categorization and it should be understood that two products that can be described identically by the categorization should not be presumed to be identical or have the same clinical utility.
1.3 This guide defines CTP-related terminology in the context of skin wounds. However, this guide does not provide a correspondence between the CTP composition and its clinical use(s). More than one product may be suitable for each clinical use, and one product may have more than one clinical use.
1.4 This guide does not purport to address safety concerns with the use of CTPs. 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 cellular and/or tissue-based products for wounds.
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.
- Guide6 pagesEnglish languagesale 15% off
- Guide6 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
4.1 Materials and devices that function at least in part by adhering to living tissues are finding increasing use in surgical procedures either as adjuncts to sutures and staples, or as frank replacements for those devices in a wide variety of medical procedures. While the nature and magnitude of the forces involved varies greatly with indication and with patient specific circumstances, all uses involve to some extent the ability of the material to resist imposed mechanical forces. Therefore, the mechanical properties of the materials, and in particular the adhesive properties, are important parameters in evaluating their fitness for use. In addition, the mechanical properties of a given adhesive composition can provide a useful means of determining product consistency for quality control or as a means for determining the effects of various surface treatments on the substrate prior to use of the device.
4.2 The complexity and variety of individual applications for tissue adhesive devices, even within a single indicated use (surgical procedure, which itself may vary depending on physical site and clinical intention) is such that the results of a single tensile strength test is not suitable for determining allowable design stresses without thorough analysis and understanding of the application, adhesive behaviors, and clinical indications.
4.3 This test method may be used for comparing adhesives or bonding processes for susceptibility to fatigue, mode of failure, and environmental changes, but such comparisons must be made with great caution since different adhesives may respond differently to varying conditions.
4.4 A correlation of the test method results with actual adhesive performance in live human tissue has not been established.
SCOPE
1.1 This test method covers a means for comparison of wound closure strength of tissue adhesives used to help secure the apposition of soft tissue. With the appropriate choice of substrate, it may also be used for purposes of quality control in the manufacture of medical devices used as tissue adhesives.
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 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.
- Standard5 pagesEnglish languagesale 15% off
This document applies to medical compression hosiery and thrombosis prophylaxis hosiery.
An important property of hosiery is the compression it exerts on the limb. This document is intended to provide a reference for testing the compressive properties in medical hosiery.
- Technical report25 pagesEnglish languagee-Library read for1 day
This document applies to medical compression hosiery and thrombosis prophylaxis hosiery.
An important property of hosiery is the compression it exerts on the limb. This document is intended to provide a reference for testing the compressive properties in medical hosiery.
- Technical report25 pagesEnglish languagee-Library read for1 day
This standard describes the requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauzes. The standard does not consider gauzes impregnated with a pharmaceutical substance.
- Standard18 pagesEnglish languagee-Library read for1 day
This standard describes the requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauzes. The standard does not consider gauzes impregnated with a pharmaceutical substance.
- Standard18 pagesEnglish languagee-Library read for1 day
This Part of EN 1644 specifies physical and chemical tests for the evaluation of finished nonwoven compresses.
- Standard28 pagesEnglish languagee-Library read for1 day
This Part of EN 1644 specifies physical and chemical tests for the evaluation of finished nonwoven compresses.
- Standard28 pagesEnglish languagee-Library read for1 day
This part of EN 1644 describes physical and chemical tests for the evaluation of nonwovens used as materials for compresses for medical use.
- Standard19 pagesEnglish languagee-Library read for1 day
This part of EN 1644 describes physical and chemical tests for the evaluation of nonwovens used as materials for compresses for medical use.
- Standard19 pagesEnglish languagee-Library read for1 day
This standard specifies requirements and test methods for the antimicrobial activity of antimicrobial wound dressings. It is designed for microbicidal and microbistatic dressings.
Test methods specifically for microbial binding are not included in the standard.
- Draft33 pagesEnglish languagee-Library read for1 day
This standard specifies requirements and test methods for the antimicrobial activity of antimicrobial wound dressings. It is designed for microbicidal and microbistatic dressings.
Test methods specifically for microbial binding are not included in the standard.
- Draft33 pagesEnglish languagee-Library read for1 day
Part 2 of prEN14079 specifies physical and chemical tests for the evaluation of absorbent cotton gauze and absorbent cotton and viscose gauze compresses and wound packing products.
Specific tests and requirements for absorbent cotton gauze and cotton and viscose gauzes used in the manufacture of compresses and wound packing products are covered in prEN 14079-1, which can be used in conjunction with this part of the standard.
NOTE 1 Biocompatibility aspects are not covered in this standard, but are addressed in EN ISO 10993.
NOTE 2 Bioburden determination methods are not covered by this standard, but are addressed in EN XXX.
- Draft12 pagesEnglish languagee-Library read for1 day
This European Standard describes the physical and chemical test methods with requirements for the evaluation of absorbent cotton gauzes and absorbent cotton and viscose gauzes used as materials for compresses and wound packing products for medical use. X-ray detectable components are included.
- Draft33 pagesEnglish languagee-Library read for1 day
AFNOR - Modification of F title
- Corrigendum2 pagesEnglish languagee-Library read for1 day
This European Standard describes a test method for the evaluation of waterproofness of primary wound dressings when such claims are made.
- Standard8 pagesEnglish languagee-Library read for1 day
This European Standard describes a test method for measuring aspects of conformability of primary wound dressings.
- Standard7 pagesEnglish languagee-Library read for1 day
This European Standard describes a test method for the evaluation of waterproofness of primary wound dressings when such claims are made.
- Standard6 pagesEnglish languagee-Library read for1 day
Part 1 of EN 13726 specifies test methods recommended for the evaluation of some aspects of absorbency of primary wound dressings.
- Standard16 pagesEnglish languagee-Library read for1 day
Part 2 of EN 13726 describes test methods recommended for the evaluation of moisture vapour transmission rate of permeable film primary wound dressings.
- Standard9 pagesEnglish languagee-Library read for1 day
SIGNIFICANCE AND USE
5.1 This test method provides quick and accurate ratings for the sensory heat in oleoresin capsicums ranging from 100 000 to 1 000 000 Scoville heat units.
5.2 Sensory results from this test method correlate highly (r2 = 0.94) with results from high pressure liquid chromatography; making the two methods substitutable.6
SCOPE
1.1 This test method describes standardized procedures for the sensory evaluation of heat in oleoresin capsicums ranging from 100 000 to 1 000 000 Scoville heat units (S.H.U.).
1.2 This test method is intended as an alternative to the Scoville heat test, but results can be expressed in Scoville heat units (see ASTA Method 21.0 and ISO 3513).
1.3 This test method does not apply for ground red pepper, low heat chili peppers, or chili powder.
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 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. Specific precautionary statements are given in Section 8.
WITHDRAWN RATIONALE
This test method described standardized procedures for the sensory evaluation of heat in oleoresin capsicums ranging from 100 000 to 1 000 000 Scoville heat units (S.H.U.).
Formerly under the jurisdiction of Committee E18 on Sensory Evaluation, this test method was withdrawn in April 2024. This standard is being withdrawn without replacement due to its limited use by industry.
- Standard4 pagesEnglish languagesale 15% off
- Standard4 pagesEnglish languagesale 15% off
AFNOR - Modification of F title
- Corrigendum2 pagesEnglish languagee-Library read for1 day
This European Standard describes a test method for measuring aspects of conformability of primary wound dressings.
- Standard7 pagesEnglish languagee-Library read for1 day
This European Standard describes a test method for the evaluation of waterproofness of primary wound dressings when such claims are made.
- Standard6 pagesEnglish languagee-Library read for1 day
Part 1 of EN 13726 specifies test methods recommended for the evaluation of some aspects of absorbency of primary wound dressings.
- Standard16 pagesEnglish languagee-Library read for1 day
Part 2 of EN 13726 describes test methods recommended for the evaluation of moisture vapour transmission rate of permeable film primary wound dressings.
- Standard9 pagesEnglish languagee-Library read for1 day
SIGNIFICANCE AND USE
5.1 Diametral compression strength is an important measure of the mechanical properties of casting materials. This test method simulates the loading pattern seen in lower extremity casting applications during ambulation. This test method cannot be used to determine cast life or measure bending or other modes of cast failure.
5.2 This test method measures but does not prescribe values.
SCOPE
1.1 This test method covers the functional diametral compression strength of cylindrical test specimens formed from synthetic fiberglass polyurethane casting materials. The test specimens employed in this test method are similar in geometry and construction to casts used in orthopaedic applications. This test method is not intended to determine the strength of the base materials used for fabrication of the test specimen.
1.2 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.
1.3 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 and health practices and determine the applicability of regulatory limitations prior to use. Specific warning statements are given in 6.7.
WITHDRAWN RATIONALE
This test method covered the functional diametral compression strength of cylindrical test specimens formed from synthetic fiberglass polyurethane casting materials.
Formerly under the jurisdiction of Committee F04 on Medical and Surgical Materials and Devices, this test method was withdrawn in February 2021. This standard is being withdrawn without replacement due to its limited use by industry.
- Standard5 pagesEnglish languagesale 15% off
This European Standard describes a test method for the evaluation of waterproofness of primary wound dressings when such claims are made.
- Standard8 pagesEnglish languagee-Library read for1 day
This European Prestandard specifies requirements and gives test methods for medical compression hosiery, including custom-made hosiery (class 030606, EN 29999), knitted from threads made of natural fibres or synthetic fibres and elastic threads. It is applicable to medical compression hosiery which is used as a medical device for the treatment of venous and/or lymphatic diseases of the leg. This European Prestandard does not give requirements connected with the manufacture of hosiery.
NOTE Manufacturing methods that have been shown by experience to be satisfactory are given for information in annex A.
- Standardization document43 pagesEnglish languagee-Library read for1 day
This European Prestandard applies to medical thrombosis prophylaxis hosiery, knitted from threads made of natural fibres or synthetic fibres and elastic threads, which is used as a medical device for prophylaxis of venous thrombosis. The prestandard specifies requirements and test methods, except for custom-made hosiery.
- Standardization document36 pagesEnglish languagee-Library read for1 day
This European Prestandard applies to medical thrombosis prophylaxis hosiery, knitted from threads made of natural fibres or synthetic fibres and elastic threads, which is used as a medical device for prophylaxis of venous thrombosis. The prestandard specifies requirements and test methods, except for custom-made hosiery.
- Standardization document36 pagesEnglish languagee-Library read for1 day
This European Prestandard specifies requirements and gives test methods for medical compression hosiery, including custom-made hosiery (class 030606, EN 29999), knitted from threads made of natural fibres or synthetic fibres and elastic threads. It is applicable to medical compression hosiery which is used as a medical device for the treatment of venous and/or lymphatic diseases of the leg. This European Prestandard does not give requirements connected with the manufacture of hosiery.
NOTE Manufacturing methods that have been shown by experience to be satisfactory are given for information in annex A.
- Standardization document43 pagesEnglish languagee-Library read for1 day
This European Standard specifies requirements for male condoms made from compounded natural rubber latex (referred to in this European Standard as condoms) supplied to consumers and designed to assist in the prevention of sexually transmitted diseases and for contraceptive purposes. Note 1: Guidance on the determination of properties of condoms that have been stored after purchase is given in Annex A, which does not form a normative part of this European Standard. Note 2: Recommendations on the storage of packaged condoms are given in Annex B, which does not form a normative part of this European Standard.
- Standard50 pagesEnglish languagee-Library read for1 day
SCOPE
1.1 This specification covers silicone elastomers intended for use as materials of construction for fabrication of medical devices.
1.2 Variations in ingredients, processing, and vulcanization (crosslinking/cure) systems of silicone elastomer are necessary to achieve the properties required in specific medical device applications.
1.2.1 An alphabetical/numerical code abbreviation is defined in this specification as what may be used to specify ingredients, crosslinking systems, processing conditions, and physical properties of many silicone elastomers used in medical device applications by a standard, abbreviated designation.
1.3 In all cases where the provisions of this specification are in conflict with those of the detailed specifications for a particular product, the latter shall take precedence.
1.3.1 When silicone elastomers are used in medical device applications where the materials requirements cannot be completely achieved by the technology prescribed in this specification, it may be necessary to adjust ingredients, processing, or cure systems to a greater extent to obtain the properties needed in these specific medical device applications.
1.3.1.1 When silicone elastomers are adjusted more extensively than prescribed in this specification, such adjustments shall be completely described and controlled in specifications for each specific material.
1.3.1.2 All sections of this specification that contain requirements pertinent to safety and effectiveness apply to all silicone elastomers used as materials of construction for medical devices, including those adjusted more broadly than defined in this specification.
1.4 While silicone elastomers have demonstrated excellent biocompatibility in medical device applications, the biocompatibility of silicone elastomers as a generic class has not been established. Many compositions and formulations are possible. Manufacturing practices, facilities, controls, process validation, and other considerations that ensure batch-to-batch duplication, assurance of identity, and quality of ingredients, as well as freedom from contamination or cross-contamination may vary widely within the silicone elastomer industry. Medical device manufacturers must ensure safety and effectiveness of each specific composition or formulation from each supplier in its intended applications. Historic, clinical, and biocompatibility data are pertinent prospectively only when all compounding, formulating, and fabrication are done in accordance with the provisions of Good Manufacturing Practice Regulations, which help ensure medical materials and devices are reasonably duplicated each time they are manufactured.
1.5 This specification is intended to assist in the development of specifications for formulated silicone elastomer compounds. It is also recommended for use in materials and finished device labeling to specify the type or types of silicone elastomers contained.
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 and health practices and determine the applicability of regulatory limitations prior to use.
- Technical specification5 pagesEnglish languagesale 15% off