ANSI/AAMI/ISO TIR16775:2014

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.