Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes

Standards Development Organisation:

Canadian Standards Association (operating as CSA Group)

Contact Information:

Canadian Standards Association (operating as CSA Group)

Working Program:

View the CSA work program

Designation Number:

ISO 11607-2

Standard Type:

National Standard of Canada - Adoption of International Standard

Standard Development Activity:

New Standard

Status:

Proceeding to development

SDO Comment Period Start Date:

2016-01-26

SDO Comment Period End Date:

2016-02-16

Posted On:

2016-01-20

Scope:

This Standard 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.

Project need:

n/a

Note: The information provided above was obtained by the Standards Council of Canada (SCC) and is provided as part of a centralized, transparent notification system for new standards development. The system allows SCC-accredited Standards Development Organizations (SDOs), and members of the public, to be informed of new work in Canadian standards development, and allows SCC-accredited SDOs to identify and resolve potential duplication of standards and effort.

Individual SDOs are responsible for the content and accuracy of the information presented here. The text is presented in the language in which it was provided to SCC.