ISO 11607-2:2006 PDF

ISO 11607-2:2006 PDF

Name:
ISO 11607-2:2006 PDF

Published Date:
04/15/2006

Status:
Active

Description:

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

Publisher:
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:
$20.4
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Identical versions for sale:
Outside United States: BS EN ISO 11607-2:2006
German: DIN EN ISO 11607-2:2006
Spanish: UNE EN ISO 11607-2:2007


ISO 11607-2:2006 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.

ISO 11607-2:2006 is applicable to industry, to health care facilities, and wherever medical devices are packaged and sterilized.

ISO 11607-2:2006 does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements may also be necessary for drug/device combinations.


File Size : 1 file , 190 KB
Note : This product is unavailable in Ukraine, Russia, Belarus
Published : 04/15/2006
Same As : ISO 11607-2:2006

History

ISO 11607-2:2019
Published Date: 02/01/2019
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
$37.2
ISO 11607-2:2006/Amd1:2014
Published Date: 07/15/2014
- Amendment 1
$5.7
ISO 11607-2:2006
Published Date: 04/15/2006
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
$20.4
ISO 11607:2003
Published Date: 02/15/2003
Packaging for terminally sterilized medical devices
$24.6

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