ASTM F2312-10
Historical Standard: ASTM F2312-10 Standard Terminology Relating to Tissue Engineered Medical Products
SUPERSEDED (see Active link, below)
ASTM F2312
1. Scope
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 1270 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 and health practices and determine the applicability of regulatory limitations prior to use.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
Government Documents
21CFRParts207,807,an Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing (January 19, 2001)Keywords
TEMPs (tissue engineered medical products); Terminology--medical/surgical systems/applications;
ICS Code
ICS Number Code 01.040.11 (Health care technology (Vocabularies)); 11.120.99 (Other standards related to pharmaceutics)
DOI: 10.1520/F2312-10
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