Table of Contents

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
        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

Abstract

Specifies guidance for the application of the requirements contained in ISO 11607-1 and ISO 11607-2.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	Canadian Standards Association
Pages
ISBN