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BS EN ISO 11607-2:2020+A11:2022 PDF

BS EN ISO 11607-2:2020+A11:2022 PDF

Name:
BS EN ISO 11607-2:2020+A11:2022 PDF

Published Date:
09/13/2022

Status:
Active

Description:

Packaging for terminally sterilized medical devices-Validation requirements for forming, sealing and assembly processes

Publisher:
British Standard / European Standard / International Organization for Standardization

Document status:
Active
Format:
Electronic (PDF)
Delivery time:
10 minutes
Delivery time (for Russian version):
200 business days
SKU:
Choose Document Language:
$79.248
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BS EN ISO 11607-2:2020 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.
File Size : 1 file , 1.3 MB
ISBN(s) : 9780539231694
Note : This product is unavailable in Ukraine, Russia, Belarus
Number of Pages : 32
Product Code(s) : 30459118, 30459118
Published : 09/13/2022

History

BS EN ISO 11607-2:2020+A1:2023
BS EN ISO 11607-2:2020+A1:2023
Published Date: 11/01/2023
Packaging for terminally sterilized medical devices-Validation requirements for forming, sealing and assembly processes
$92.964
BS EN ISO 11607-2:2020+A11:2022
BS EN ISO 11607-2:2020+A11:2022
Published Date: 09/13/2022
Packaging for terminally sterilized medical devices-Validation requirements for forming, sealing and assembly processes
$79.248
BS EN ISO 11607-2:2006+A1:2014
BS EN ISO 11607-2:2006+A1:2014
Published Date: 09/30/2014
Packaging for terminally sterilized medical devices-Validation requirements for forming, sealing and assembly processes
$57.15

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BS ISO 21881:2019
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