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DANSK DSF/FPREN ISO 11607-2 PDF

DANSK DSF/FPREN ISO 11607-2 PDF

Name:
DANSK DSF/FPREN ISO 11607-2 PDF

Published Date:

Status:
[ Draft-Obsolete ]

Description:

Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes (ISO/FDIS 11607-2:2018)

Publisher:
Dansk Standard

Document status:
Active
Format:
Electronic (PDF)
Delivery time:
10 minutes
Delivery time (for Russian version):
200 business days
SKU:
Choose Document Language:
$12
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DRAFT * W/D S/S BY DS/EN ISO 11607-2

This part of ISO 11607 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. This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices are packaged and sterilized. This part of ISO 11607 does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements may also be necessary for drug/device combinations.


Edition : 18
File Size : 1 file , 1.2 MB
Number of Pages : 34
Product Code(s) : DSF-021, DSF-021

History

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