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DANSK DS/EN ISO 11607-2 PDF

DANSK DS/EN ISO 11607-2 PDF

Name:
DANSK DS/EN ISO 11607-2 PDF

Published Date:
04/20/2006

Status:
[ Revised ]

Description:

Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes

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:
$19.2
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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 : 06
File Size : 1 file , 340 KB
Number of Pages : 26
Product Code(s) : DS-026, DS-026
Published : 04/20/2006

History

DANSK DSF/EN ISO 11607-2/PRA1
DANSK DSF/EN ISO 11607-2/PRA1
Published Date:
Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
$12
DANSK DS/EN ISO 11607-2
DANSK DS/EN ISO 11607-2
Published Date: 01/20/2020
Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
$19.2
DANSK DS/EN ISO 11607-2
DANSK DS/EN ISO 11607-2
Published Date: 07/31/2017
Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)
$19.2
DANSK DS/EN ISO 11607-2
DANSK DS/EN ISO 11607-2
Published Date: 04/20/2006
Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes
$19.2

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