ISO 11607-2:2006 PDF Download
Standard EN Sample
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
Also Known As:
SKU915236228
Published by
International Organization for Standardization
ISO
Publication Date2006-04
Pages CountPages18
ISO 11607-2:2006 specifies the requirements for 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.
ISO 11607-2:2006 is applicable to industry, to health care facilities, and wherever medical devices are packaged and sterilized.
ISO 11607-2:2006 does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements may also be necessary for drug/device combinations.
Details
History and complementary documents
History
| Edition | 1 |
| ICS Codes | 11.080.30 - Sterilized packaging |
| Language(s) | English |
| File Size | 184.3 KB |
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