Published Updates on March 8, 2024:

1. Medical Gloves for Single Use:

   • EN 455-3:2023: Requirements and testing for biological evaluation​

2. Biological Evaluation of Medical Devices:

   • EN ISO 10993-15:2023: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019)​

   • EN ISO 10993-17:2023: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023)

   • EN ISO 10993-18:2020/A1:2023: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)​

3. Sterilization of Health Care Products:

   • EN ISO 11137-2:2015/A1:2023: Establishing the sterilisation dose using radiation (ISO 11137-2:2013)​

4. Packaging for Terminally Sterilized Medical Devices:

   • EN ISO 11607-1:2020/A1:2023: Requirements for materials, sterile barrier systems, and packaging systems (ISO 11607-1:2019)​

   • EN ISO 11607-2:2020/A1:2023: Validation requirements for forming, sealing, and assembly processes (ISO 11607-2:2019)​

5. Processing of Health Care Products:

   • EN ISO 17664-2:2023: Information to be provided by the medical device manufacturer for the processing of non-critical medical devices (ISO 17664-2:2021)​