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DANSK DS/ISO 11607-2 PDF

DANSK DS/ISO 11607-2 PDF

Name:
DANSK DS/ISO 11607-2 PDF

Published Date:
01/20/2020

Status:
[ Active ]

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:
$19.8
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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 : 20#
File Size : 1 file , 1.8 MB
Number of Pages : 22
Product Code(s) : DS-021, DS-021
Published : 01/20/2020

History

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