Packaging For Terminally Sterilized Medical Devices Validation Requirements For Forming Sealing And Assembly Processes PDF Download

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Packaging for Terminally Sterilized Medical Devices

Packaging for Terminally Sterilized Medical Devices
Author:
Publisher:
Total Pages: 0
Release: 2022
Genre:
ISBN: 9780539231694

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BS EN ISO 11607-2:2020 specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems. It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized. It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.


Packaging for Terminally Sterilized Medical Devices. Validation Requirements for Forming, Sealing and Assembly Processes

Packaging for Terminally Sterilized Medical Devices. Validation Requirements for Forming, Sealing and Assembly Processes
Author: British Standards Institute Staff
Publisher:
Total Pages: 26
Release: 1918-05-15
Genre:
ISBN: 9780580964343

Download Packaging for Terminally Sterilized Medical Devices. Validation Requirements for Forming, Sealing and Assembly Processes Book in PDF, ePub and Kindle

Sealing processes, Packaging, Packaging processes, Acceptance (approval), Sterile equipment, Performance testing, Seals, Verification, Packaging materials, Sterilization (hygiene), Packages, Medical equipment, Medical instruments, Wrapping, Performance, Quality assurance systems, Quality