SS-EN-ISO-11607-2-AM11 › Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
SS-EN-ISO-11607-2-AM11
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2020 EDITION AMENDEMNT 11
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CURRENT
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This document 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.
To find similar documents by classification:
11.080.30 (Sterilized packaging)
Active implantable medical devices. Medical devices. In vitro diagnostic medical devices
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Designation Name
SS-EN ISO 11607-2:2020/A11:2022
Revision Level
2020 EDITION AMENDEMNT 11
Status
Current
Publication Date
June 21, 2022
Language(s)
English
Page Count
16
International Equivalent
EN ISO 11607-2:2020/A11:2022(IDT); ISO 11607-2:2019(IDT)