AAMI TIR19 : 1998
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
GUIDANCE FOR ANSI/AAMI/ISO 10993-7: 1995, BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS
Hardcopy , PDF
13-01-2009
01-01-1998
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Committee representation.
Foreword
Introduction
Guidance
Annex A-Simulated-use extraction procedure
Gives guidance on the application of parts of the ANSI/AAMI/ISO 10993 series of standards to the biological evaluation of medical devices that have been sterilized with ethylene oxide.
| Committee |
WG 63
|
| DevelopmentNote |
Supersedes AAMI ST29 and AAMI ST30 (07/2002)
|
| DocumentType |
Standard
|
| Pages |
24
|
| ProductNote |
NEW CHILD AMD 1 IS NOW ADDED.<br>
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| Supersedes |
| Standards | Relationship |
| ISO 10993-7:2008 | Identical |
| 14/30295067 DC : 0 | BS EN ISO 16671 - OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY |
| S.R. CEN ISO/TS 16775:2014 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 (ISO/TS 16775:2014) |
| CAN/CSA-ISO/TS 16775:17 | Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2 (Adopted ISO technical specification 16775:2014, first edition, 2014-05-15) |
| ASTM F 2212 : 2011 : REDLINE | Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs) |
| CEN ISO/TS 16775:2014 | Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2014) |
| PD CEN ISO/TS 16775:2014 | Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2 |
| ASTM F 2064 : 2017 : REDLINE | Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications |
| ANSI Z80.7 : 2013 | OPHTHALMIC OPTICS - INTRAOCULAR LENSES |
| ASTM F 3089 : 2014 | Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions |
| BS EN ISO 16671 : 2015 | OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY |
| ISO 16671:2015 | Ophthalmic implants — Irrigating solutions for ophthalmic surgery |
| AAMI RD16 : 2007 | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HEMODIALYZERS, HEMODIAFILTERS, HEMOFILTERS AND HEMOCONCENTRATORS |
| ASTM F 2103 : 2011-03 | GUIDE FOR CHARACTERIZATION AND TESTING OF CHITOSAN SALTS AS STARTING MATERIALS INTENDED FOR USE IN BIOMEDICAL AND TISSUE-ENGINEERED MEDICAL PRODUCT APPLICATIONS |
| I.S. EN ISO 16671:2015 | OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY (ISO 16671:2015) |
| 02/560790 DC : DRAFT FEB 2002 | BS EN ISO 16671 - OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY |
| ANSI/AAMI/ISO TIR16775:2014 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 |
| ISO/TS 16775:2014 | Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2 |
| UNI CEN ISO/TS 16775 : 2014 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 |
| AAMI TIR20 : 2001 | PARAMETRIC RELEASE FOR ETHYLENE OXIDE STERILIZATION |
| UNE-EN ISO 16671:2016 | Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2015) |
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