EN ISO 11607-1:2006

Name: EN ISO 11607-1:2006
Brand: CEN
SKU: EN ISO 11607-1:2006
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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

Current stage: 99.60 Withdrawal effective Jun 3, 2009

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Status: Withdrawn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

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

93/42/EEC

Medical devices

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WITHDRAWN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WITHDRAWN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WITHDRAWN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