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AAMI - TIR19 AMD 1

Guidance for ANSI/AAMI/ISO 10993-7:1995, Biological evaluation of medical deices—Part 7: Ethylene oxide sterilization residuals Amendment

inactive, Most Current
Organization: AAMI
Publication Date: 1 January 1999
Status: inactive
Page Count: 6

Document History

TIR19 AMD 1
January 1, 1999
Guidance for ANSI/AAMI/ISO 10993-7:1995, Biological evaluation of medical deices—Part 7: Ethylene oxide sterilization residuals Amendment
A description is not available for this item.
TIR19
January 1, 1998
Guidance for ANSI/AAMI/ISO 10993-7:1995, Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals
This AAMI Technical Information Report (TIR) provides guidance to augment ANSI/AAMI/ISO 10993-7, Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals. This TIR is...

References

This document is referenced by:
ISO TS 16775 - Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
Published by ISO on May 15, 2014
This Technical Specification provides guidance for the application of the requirements contained in ISO 11607‑1 and ISO 11607‑2. It does not add to, or otherwise change, the requirements of ISO...
This document is referenced by:
ASTM F2103 - Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue- Engineered Medical Product Applications
Published by ASTM on June 1, 2018
This guide covers the evaluation of chitosan salts suitable for use in biomedical or pharmaceutical applications, or both, including, but not limited to, tissue-engineered medical products (TEMPS)....
This document is referenced by:
ASTM F2212 - Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
Published by ASTM on December 1, 2020
This guide for characterizing collagen-containing biomaterials is intended to provide characteristics, properties, and test methods for use by producers, manufacturers, and researchers to more...
This document is referenced by:
AAMI TIR16775 - Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
Published by AAMI on January 1, 2014
This Technical Specification provides guidance for the application of the requirements contained in ISO 11607-1 and ISO 11607-2. It does not add to, or otherwise change, the requirements of ISO...
This document is referenced by:
PD CEN ISO/TS 16775 - Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2
Published by BSI on November 30, 2021
A description is not available for this item.
This document is referenced by:
EN ISO 11979-8 - Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements
Published by CEN on May 1, 2017
This document specifies fundamental requirements for all types of intraocular lenses intended for surgical implantation into the anterior segment of the human eye, excluding corneal implants and...
This document is referenced by:
DIN CEN ISO/TS 16775 - Verpackungen fuer in der Endverpackung sterilisierte Medizinprodukte - Leitfaden fuer die Anwendung von ISO 11607-1 und ISO 11607-2 (ISO/TS 16775:2014); Deutsche Fassung CEN ISO/TS 16775:2014
Published by DIN on October 1, 2014
Diese Technische Spezifikation enthält Leitlinien für die Anwendung der in ISO 11607-1 und ISO 11607-2 enthaltenen Anforderungen. Durch das vorliegende Dokument werden die Anforderungen von ISO...
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