Search Harmonised Standards in ASEAN: ICS

Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes / ISO 11607-2:2006

ISO 11607-2:2006 specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing, and…  [More Details+]

Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices / ISO 11137-1:2006

ISO 11137-1:2006 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. Although the scope of ISO 11137-1:2006…  [More Details+]