EN ISO 11607-2:2017

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006, including Amd 1:2014)

Publication date:   Nov 15, 2017

General information

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

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Scope

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.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Life cycle

PREVIOUSLY

Replaces
EN ISO 11607-2:2006

Replaces
EN ISO 11607-2:2006/A1:2014

NOW

WITHDRAWN
EN ISO 11607-2:2017
99.60 Withdrawal effective
Jan 15, 2020

REVISED BY

PUBLISHED
EN ISO 11607-2:2020

Relations

Adopted from ISO 11607-2:2006 IDENTICAL

Adopted from ISO 11607-2:2006/Amd 1:2014 IDENTICAL