ISO-11607-2 › Historical Revision Information
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes

ISO-11607-2 - 1ST EDITION - SUPERSEDED -- See the following: ISO-11607-2-AM1
Show Complete Document History

Document Center Inc. is an authorized dealer of ISO standards.
The following bibliographic material is provided to assist you with your purchasing decision:


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.

ORDER

To find similar documents by classification:

11.080.30 (Sterilized packaging)

This document comes with our free Notification Service, good for the life of the document.

This document is available in either Paper or PDF format.

Document Number

ISO 11607-2:2006

Revision Level

1ST EDITION

Status

Superseded

Publication Date

April 15, 2006

Committee Number

ISO/TC 198