EN ISO 11607-2:2006

Name: EN ISO 11607-2:2006
Brand: CEN
SKU: EN ISO 11607-2:2006
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Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006) EN ISO 11607-2:2006

Publication date: Aug 10, 2006

General information

Current stage: 99.60 Withdrawal effective Jul 19, 2017

Originator: CEN

Owner: CEN/TC 102 Sterilizers and associated equipment for processing of medical devices

Type: European Norm

ICS: 11.080.30 Sterilized packaging

Buying

Status: Withdrawn

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

Harmonized/Supporting

NOW

WITHDRAWN
EN ISO 11607-2:2006
99.60 Withdrawal effective
Jul 19, 2017

CORRIGENDA / AMENDMENTS

WITHDRAWN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

REVISED BY

WITHDRAWN
EN ISO 11607-2:2017