ISO 11607-1 Packaging for Final Sterilized Medical Devices - Part 1: Rules for Materials, Sterile Barrier Systems and Packaging Systems

The ISO 11607-1 standard has been designed by the International Organization for Standards (ISO) to describe the properties and testing methods of sterilized medical device packaging, materials, sterile barrier systems and packaging systems.

This standard has also been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN ISO 11607-1 Packaging for finally sterilized medical devices - Part 1: Rules for materials, sterile barrier systems and packaging systems.

This standard describes requirements and test methods for materials to maintain sterility of terminally sterilized medical devices to the point of use, pre-formed sterile barrier systems and packaging systems. This standard applies to businesses, healthcare organizations, and wherever medical devices are placed and sterilized in sterile barrier systems.

This standard does not cover requirements for sterile barrier systems and packaging systems of aseptic manufactured medical devices. Sometimes additional requirements are required for drug and device combinations. In addition, the ISO 11607-1 standard does not define a quality assurance system for the control of all stages of production. Likewise, this standard does not apply to packaging materials or systems that contain a contaminated medical device during the reprocessing or disposal of the substance.

Sterile barrier systems are used to ensure safety of terminally sterilized medical devices. In legal regulations, the critical structure of sterile barrier systems is considered an accessory or a component of the medical device. Sterile barrier systems used in health institutions for use in internal sterilization are accepted as medical devices all over the world.

Within the framework of laboratory testing services, TS EN ISO 11607-1 sterilized medical device packaging, materials, sterile barrier systems and packaging systems testing services are also provided by our organization.