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CEN ISO/TS 16775:2014

Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2014)

General information

Withdrawn from 01.12.2021
Base Documents
ISO/TS 16775:2014; CEN ISO/TS 16775:2014
Directives or regulations
None

Standard history

Status
Date
Type
Name
01.12.2021
Main
01.07.2014
Main
This document will provide 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 devices - Part 2: Validation requirements for forming, sealing, and assembly processes. Possible options for compliance with the requirements of Parts 1 and 2 will be addressed as special concerns than may require attention due to regional or local conditions,
practices or regulations. Additional guidance on important packaging issues will also be included (see attached outline).

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