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:

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 , 780 KB
ISBN(s) :	9780539038385
Note :	This product is unavailable in Ukraine, Russia, Belarus
Number of Pages :	24
Product Code(s) :	30390959, 30390959
Published :	01/20/2020
Same As :	BS EN ISO 11607-2:2020

BS EN ISO 11607-2:2020 PDF

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

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