ISO11607 Medical Device Packaging
ISO 11607-2 Packaging for terminally sterilised medical devices — Part 2: Validation requirements for forming, sealing and assembly processes - has been revised and will be republished in November 2018. Part 1 - Requirements for materials, sterile barrier systems and packaging systems, will be updated at the same time.
The new versions of these standards will further emphasise the need for sterile medical devices to reach their point of use in an uncontaminated condition. New, is the emphasis on human factors including consideration of the opening of packaging by the end user.
MET’s complete validation service covers your processing, product stability and the resistance to transit damage provided by your protective packaging.
Sterile barrier system (SBS) tests at MET include seal strength and integrity tests. These tests: burst peel, bubble leak, dye penetration and visual inspection are described here.
Materials are also important with puncture and tear resistance being a consideration. The materials must also be biocompatible and not transfer chemical substances to the devices inside.
We will publish further news once the new standards become available.