BS EN ISO 11607-2:2006+A1:2014

Packaging for terminally sterilized medical devices - Validation requirements for forming, sealing and assembly processes

Published:

31 May 2006

•

Withdrawn:

15 May 2018

1 Scope

This part of ISO 11607 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.

This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices are packaged and sterilized.

This part of ISO 11607 does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements may also be necessary for drug/device combinations.

Product Details

Descriptors

Packaging materials

Performance

Quality

Packaging

Sterilization (hygiene)

Seals

Wrapping

Quality assurance systems

Packages

Medical instruments

Medical equipment

Sterile equipment

Sealing processes

Acceptance (approval)

Performance testing

Verification

Packaging processes

ICS Codes

11.080.30 Sterilized packaging

Committee

CH/198

International relationships

Identical to:

EN ISO 11607-2:2006/A1:2014

ISO 11607-2:2006/Amd 1:2014

ISBN

978 0 580 77067 8

Publisher

BSI