ASTM F 2386 : 2004
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Standard Guide for Preservation of Tissue Engineered Medical Products (TEMPs) (Withdrawn 2013)
Hardcopy , PDF
04-01-2013
English
01-06-2004
Important note : Users cannot be edited or removed once added to your Multi user PDF.CONTAINED IN VOL. 13.01, 2012 Includes development of standards related to the preservation of cells, tissues, and tissue engineered medical products (TEMPs).
| Committee |
F 04
|
| DocumentType |
Guide
|
| Pages |
5
|
| PublisherName |
American Society for Testing and Materials
|
| Status |
Withdrawn
|
1.1 This guide covers the development of standards related to the preservation of cells, tissues, and tissue engineered medical products (TEMPs). Preservation techniques include freezing, vitrification, and hypothermic preservation. This guide discusses preservation, including issues of pre-preservation processing, the process of preservation, storage, transport, recovery, post-preservation processing, quality assurance, and process control.
1.2 This guide contains general guidelines for the preservation of cells, tissues, and tissue engineered medical products (TEMPs) and will identify more specific parameters relevant to the preservation of TEMPs.
1.3 This guide does not apply to any medical products of human origin regulated by the U.S. Food and Drug Administration (FDA) under 21 CFR Parts 16 and 1270 and 21 CFR Parts 207, 807, and 1271.
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 requirements prior to use.
| DIN ISO 13022 E : 2014 | MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES (ISO 13022:2012) |
| ASTM F 2383 : 2011 | Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs) (Withdrawn 2020) |
| ASTM F 2383 : 2011 : REDLINE | Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs) |
| DIN ISO 13022:2014-06 | MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES (ISO 13022:2012) |
| ASTM F 3223 : 2017 | Standard Guide for Characterization and Assessment of Tissue Engineered Medical Products (TEMPs) for Knee Meniscus Surgical Repair and/or Reconstruction |
| ISO 13022:2012 | Medical products containing viable human cells — Application of risk management and requirements for processing practices |
| 10/30203224 DC : 0 | BS ISO 13022 - MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES |
| ANSI/AAMI/ISO 13022:2012 | MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES |
| ASTM E 1564 : 2000 | Standard Guide for Design and Maintenance of Low-Temperature Storage Facilities for Maintaining Cryopreserved Biological Materials |
| CFR 21(PTS600-799) : 0 | FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 600-799 |
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