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DANSK DSF/EN ISO 11607-2/PRA1 PDF

DANSK DSF/EN ISO 11607-2/PRA1 PDF

Name:
DANSK DSF/EN ISO 11607-2/PRA1 PDF

Published Date:

Status:
[ Draft-Obsolete ]

Description:

Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)

Publisher:
Dansk Standard

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

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.


Edition : 22#
File Size : 1 file , 1.5 MB
Number of Pages : 23
Product Code(s) : DSF-021, DSF-021

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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