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ASTM F 2027 : 2016 : REDLINE

Current

Current

The latest, up-to-date edition.

Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products

Available format(s)

PDF

Language(s)

English

Published date

01-10-2016

CONTAINED IN VOL. 13.01, 2016 Gives guidance on writing a materials specification for raw or starting biomaterials intended for use in tissue engineering scaffolds for growth, support, or delivery of cells and/or biomolecules.

Committee
F 04
DocumentType
Redline
Pages
8
PublisherName
American Society for Testing and Materials
Status
Current

1.1This document provides guidance on writing a materials specification for raw or starting materials intended for use in tissue engineering scaffolds for growth, support, or delivery of cells and/or biomolecules. This guide does not apply to materials that are already in a scaffold form or are finished tissue-engineered medical products.

1.2The purpose of this guide is to provide a compendium of relevant existing standards and test methods for materials already commonly used within medical products and to provide characterization guidance for interim use of raw materials for which a standard does not exist.

1.3This guide covers specifications and characterizations of all the major classes of materials including polymers, ceramics, metals, composites, and natural tissues of human, animal, or plant origin. This guide does not apply to pharmaceuticals.

1.4This guide is focused on specification of chemical, physical, and mechanical properties of the raw or starting material. It does not include safety and biocompatibility requirements since safety and biocompatibility testing is typically done on materials fabricated into a final form to include all possible effects of fabrication and sterilization techniques.

1.5Compliance with materials specifications developed in accordance with this standard may not necessarily result in a material suitable for its intended purpose. Additional testing specific to the intended use may be required.

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ASTM F 2211 : 2013 Standard Classification for Tissue Engineered Medical Products (TEMPs)
DIN ISO 13022 E : 2014 MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES (ISO 13022:2012)
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ISO 13022:2012 Medical products containing viable human cells — Application of risk management and requirements for processing practices
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ASTM F 1472 : 2014 : REDLINE Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
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ASTM F 1873 : 1998 Standard Specification for High-Purity Dense Yttria Tetragonal Zirconium Oxide Polycrystal (Y-TZP) for Surgical Implant Applications (Withdrawn 2007)
ISO 10993-17:2002 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
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ISO 6474:1994 Implants for surgery Ceramic materials based on high purity alumina
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