EVS-EN ISO 11607-1:2020

ISO 11607-1 describes requirements and test methods for materials, preformed sterile and sterile barrier systems, and packaging systems. This standard can be used by anyone in the healthcare industry or healthcare facilities.

The process of designing and developing a packaging system for terminally sterilized medical devices is a complicated and critical endeavour. The device components and the packaging system should be combined to create a sterile medical device that performs efficiently, safely and effectively in the hands of the user.

ISO 11607-1 does not cover all requirements for sterile barrier systems and packaging systems for medical devices manufactured aseptically. Additional requirements can be necessary for drug or device combinations. It also does not describe a quality assurance system for control of all stages of manufacture.

The standard can not be applied to packaging materials or systems used to contain a contaminated medical device during the transportation of the item to the site of reprocessing or disposal.

The international standard has been approved in Europe as EN ISO 11607-1:2020 without any changes and it supersedes EN ISO 11607-1:2017.