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  • BSI
    PD CEN ISO/TS 16775:2014 Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2
    Edition: 2014
    $614.12
    / user per year

Description of PD CEN ISO/TS 16775:2014 2014

This Technical Specification provides guidance for the application of the requirements contained in ISO 11607-1 and ISO 11607-2. It does not add to, or otherwise change, the requirements of ISO 11607-1 and/or ISO 11607-2. 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 ISO 11607-1 and/or ISO 11607-2 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 Clause 3) and for the medical devices industry (see Clause 4).

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.



Standard NumberPD CEN ISO/TS 16775:2014
TitlePackaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2
StatusWithdrawn
Publication Date2014-05-31
Withdrawn Date2021-11-26
Replaced ByPD CEN ISO/TS 16775:2021
Identical National Standard OfISO/TS 16775:2014, CEN ISO/TS 16775 (ISO/TS 16775:2014) AS
DescriptorsSterilization (hygiene), Acceptance (approval), Medical instruments, Sterile equipment, Packaging processes, Test methods, Quality assurance systems, Seals, Performance, Packages, Wrapping, Sealing processes, Compatibility, Verification, Design, Medical equipment, Packaging materials, Quality, Performance testing, Packaging
ICS11.080.30 Sterilized packaging
CommitteeCH/198
ISBN978 0 580 74178 4
PublisherBSI
Pages126

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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