Preface:

This is the second edition of CSA ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 11607-1 (second edition, 2019-02). It supersedes the previous edition, published in 2016 as CAN/CSA-ISO 11607-1 (adopted ISO 11607-1:2006, including Amendment 1:2014).

CSA Group acknowledges that the adoption of this Standard was made possible, in part, by the financial support of the governments of Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Northwest Territories, Nova Scotia, Nunavut, Ontario, Prince Edward Island, Québec, Saskatchewan, and Yukon, as administered by the Canadian Agency for Drugs and Technologies in Health (CADTH).

This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group.

Scope:

This document specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.

It is applicale to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized.

It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.

It does not describe a quality assurance system for control of all stages of manufacture.

It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.