99.60 Withdrawal effective Jan 15, 2020
CEN
CEN/TC 102 Sterilizers and associated equipment for processing of medical devices
European Norm
11.080.30 Sterilized packaging
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.
Legislation related to this standard
WITHDRAWN
EN ISO 11607-2:2017
99.60
Withdrawal effective
Jan 15, 2020
PUBLISHED
EN ISO 11607-2:2020