BS EN ISO 11607-2:2017

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

Published:

31 May 2018

•

Withdrawn:

20 Jan 2020

What is this standard about?

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.

Who is this standard for?

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

Quality

Quality assurance systems

Performance

Wrapping

Medical instruments

Medical equipment

Packages

Sterilization (hygiene)

Packaging materials

Verification

Seals

Performance testing

Sterile equipment

Acceptance (approval)

Packaging processes

Packaging

Sealing processes

ICS Codes

11.080.30 Sterilized packaging

Committee

CH/198

International relationships

Identical to:

ISO 11607-2:2019

EN ISO 11607-2:2017

ISO 11607-2:2006

ISBN

978 0 580 96434 3

Publisher

BSI