ANSI AAMI ISO 11607-2-2006 (R2015)

Category: Technical


Posted on 2020-09-14, by banz.

Description

Packaging For Terminally Sterilized Medical Devices - Part 2: Validation Requirements For Forming, Sealing And Assembly Processes. Specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized and maintain sterility to the point of use. These processes include forming, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems, and packaging systems.

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ANSI AAMI ISO 11607-2-2006 (R2015)

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