ANSI/AAMI/ISO TIR16775:2014
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2
English
28-07-2014
08-04-2024
Glossary of equivalent standards
Committee representation
Background of AAMI adoption of
ISO/TS 16775:2014
Foreword
Introduction
1 Scope
2 Terms and definitions
3 Guidance for health care facilities
4 Guidance for industry
Annex A (informative) - Selection, evaluation and
testing of packaging materials and sterile
barrier systems - Guidance for industry
and health care facilities
Annex B (informative) - Sterilization
considerations - Guidance for industry
and health care facilities
Annex C (informative) - Examples of wrapping
methods - Guidance for health care facilities
Annex D (informative) - Validation plan
documents - Guidance for health care facilities
Annex E (informative) - Installation qualification
documentation - Guidance for health care facilities
Annex F (informative) - Operational qualification
documentation - Guidance for health care facilities
Annex G (informative) - Performance qualification
documentation - Guidance for health care facilities
Annex H (informative) - Addressing worst-case
requirements - Guidance for industry and
health care facilities
Annex I (informative) - Generating a final packaging
system validation protocol - Guidance for industry
Annex J (informative) - Design inputs - Medical device
attributes - Guidance for industry
Annex K (informative) - Risk analysis tools - Guidance
for industry and health care facilities
Annex L (informative) - Considerations for sampling
plans - Guidance for health care facilities
Annex M (informative) - Stability testing
(ISO 11607-1:2006, 6.4) - Guidance for industry
Annex N (informative) - Use of the Internet - Guidance
for industry and health care facilities
Annex O (informative) - Test method validation - Guidance
for industry
Annex P (informative) - Use of contract packagers - Guidance
for industry and health care facilities
Annex Q (informative) - Guidance on establishing process
parameters - Guidance for industry
Annex R (informative) - Investigation failure - Guidance
for industry and health care facilities
Annex S (informative) - Packaging manufacturing process
and packaging system design feasibility
evaluation - Guidance for industry
Bibliography
This technical report contains guidance on the application of ISO 11607-1:2006, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems and ISO 11607-2:2006, Packaging for terminally sterilized medical device - Part 2: Validation requirements for forming, sealing, and assembly processes.
| Committee |
WG 07
|
| DevelopmentNote |
Supersedes AAMI TIR22. (11/2014)
|
| DocumentType |
Technical Report
|
| ISBN |
1-57020-559-0
|
| Pages |
128
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO/TS 16775:2014 | Identical |
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