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EN ISO 11607-1:2006

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006) EN ISO 11607-1:2006

Publication date:   Aug 10, 2006

General information

99.60 Withdrawal effective   Jun 3, 2009

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

This standard specifies the requirements and test methods for packaging materials and final packages (systems) that are intended to maintain sterility of the terminally sterilized medical devices to the point of use. This standard is applicable to industry, health care facilities, and whererver sterilized medical devices are packed and sterilized.

Related legislation

Legislation related to this standard

90/385/EEC

Active implantable medical devices

Legislation 90/385/EEC
93/42/EEC

Medical devices

Legislation 93/42/EEC

Life cycle

PREVIOUSLY

WITHDRAWN
EN 868-1:1997

NOW

WITHDRAWN
EN ISO 11607-1:2006
99.60 Withdrawal effective
Jun 3, 2009

REVISED BY

WITHDRAWN
EN ISO 11607-1:2009