AAMI 11607-2:2019 PDF Download
Standard EN Sample
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
Also Known As: ANSI/AAMI/ISO 11607-2:2019
SKU195282143
Published by
Association for the Advancement of Medical Instrumentation
AAMI
Publication Date2019
Pages CountPages26
Full Description
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.
Details
| Edition | 2 |
| Language(s) | English |
| ISBN | 9781570207204 |
| File Size | 634.9 KB |
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