PD CEN 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

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

This Technical Specification provides guidance for the application of the requirements contained in ISO11607-1 and ISO11607-2. It does not add to, or otherwise change, the requirements of ISO11607-1 and/or ISO11607-2. This is an informative document, not normative. It does not include requirements to be used as basis of regulatory inspection or certification assessment activities.

The guidance can be used to better understand the requirements of ISO11607-1 and/or ISO11607-2 and illustrates some of the variety of methods and approaches available for meeting the requirements of those International Standards. It is not required that this document be used to demonstrate compliance with them.

Guidelines are given for evaluation, selection and use of packaging materials, preformed sterile barrier systems, sterile barrier systems and packaging systems. Guidance on validation requirements for forming, sealing and assembly processes is also given.

This Technical Specification provides information for health care facilities (see Clause3) and for the medical devices industry (see Clause4).

It does not provide guidance for applications of packaging materials and systems after their opening. In the use of packaging for other purposes such as a “sterile field” or transport of contaminated items, other regulatory standards will apply.