The amendment to UNE-EN ISO 11607-1:2020/A1:2024 is now available.
The UNE-EN ISO 11607-1:2020 standard specifies the testing requirements and methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems intended to keep medical devices terminally sterilized until their point of use.
It is applicable to industry, healthcare facilities, and wherever medical devices are placed in sterile barrier systems and sterilized.
The Annexes included to assist in implementing the standard include:
- Annex B. Informative. Standardized test methods, guides and procedures that can be used to demonstrate conformity with the requirements of this document.
- Annex E. Informative. Draft guidance on how to differentiate a sterile barrier system from protective packaging.