PDF Price
$83.00
ADD TO CART
ASTM is one of the leading standards developers for medical devices. With 24 categories, addressing everything from surgical implements to automated analysis, ASTM medical device standards cover a truly wide range. With how much research and training goes into the medical industry, standardization plays a key role in productively actualizing that effort. Organized below for your convenience by usage, industry, and theme are over 300 standards. This list includes standards related to Classification and Terminology for TEMPs.
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.
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.
1.1 This terminology defines basic terms and presents the relationships of the scientific fields related to Tissue Engineered Medical Products (TEMPs). Committee F04 has defined these terms for the specific purpose of unifying the language used in standards for TEMPs. 1.2 The terms and relationships defined here are limited to TEMPs. They do not apply to any medical products of human origin regulated by the U.S. Food and Drug Administration under 21 CFR Parts 16 and 21 CFR Parts 207, 807, and 1271. 1.3 The terms and nomenclature presented in this standard are for the specific purposes of unifying the language used in TEMP standards and are not intended for labeling of regulated medical products. 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.
1.1 This guide defines terminology and provides classification for products that can be substituted for tissue grafts of human or animal tissue in medical and surgical therapies of skin lesions. 1.2 This guide provides a classification method for skin substitutes by comparing their clinical uses with those of conventional tissue grafts. However, skin substitutes may also have equivalent, superior, or inferior clinical properties in comparison to conventional tissue grafts. Clinical classification is independent of the materials and technology used to make a skin substitute, or whether its components include human or animal tissue or other biological or non-biological materials. 1.3 This guide also describes a nomenclature for systematic description of the technologies and components of skin substitutes that is independent of their clinical utilities. This systematic nomenclature is not intended to be prescriptive for product labeling, and it describes only the most salient characteristics of skin substitutes; the actual biological and clinical functions of skin substitutes can depend on characteristics not recognized in the nomenclature, and it should be understood that two products that can be described identically by the nomenclature should not be presumed to be identical or have the same clinical utility. 1.4 This guide does not provide a correspondence between the skin substitute composition and the clinical classification. Also, more than one product may be suitable for each clinical use, and one product may have more than one clinical 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.