1What the standard covers

ISO 11607 applies to industry, healthcare facilities and anyone who packages medical devices that are sterilized after packaging. Its purpose is to ensure that the packaging system maintains sterility until the point of use and allows aseptic presentation.

2Part 1 — materials, sterile barrier systems and packaging systems

Part 1 requires that materials are demonstrated to be a microbial barrier, are compatible with the intended sterilization process, are free of toxic substances that could transfer to the device, are suitable for labelling, and are stable through storage. It also requires that the packaging system as a whole protects the device through handling and distribution, and that seal integrity can be demonstrated.

3Part 2 — validation of forming, sealing and assembly processes

Part 2 applies to the process of making the pack: it requires installation, operational and performance qualification (IQ/OQ/PQ) of sealing equipment, definition of critical parameters such as temperature, pressure and dwell time, and routine monitoring. In a hospital CSSD this translates to validating and monitoring the heat sealer.

4How EN 868 relates to ISO 11607

The EN 868 series gives detailed test methods and requirements for specific materials. EN 868-5 covers sealable pouches and reels of porous materials and plastic film — the classic paper/film pouch and reel. A pouch that conforms to EN 868-5 is generally used to demonstrate conformity of the material with ISO 11607-1.

5What to ask your supplier

  • A statement of conformity to ISO 11607-1 and EN 868-5 for each pouch and reel product.
  • The manufacturer's ISO 13485 certificate.
  • Test data: microbial barrier, seal strength, burst and peel tests, indicator performance.
  • Lot traceability and shelf-life information.

6Conclusion

ISO 11607 turns "the pack looks fine" into demonstrable evidence. Choosing packaging that is documented against ISO 11607-1 and EN 868-5, and validating your own sealing process to ISO 11607-2, closes the loop between the sterilizer and the operating table.

7Frequently asked questions

Is ISO 11607 mandatory?

It is the recognised state of the art referenced by regulators and accreditation bodies worldwide. Device manufacturers must demonstrate compliance for CE marking and FDA submissions; healthcare facilities are expected to use conforming packaging.