Official reference source
Read the linked decisions and amendments to identify the exact cited edition, the date the citation takes effect, any restriction and any cessation date. Commission summary lists provide a convenient index; legal effects follow from the relevant acts.
Indexed standard references
23 reference strings from the source snapshots are linked to this framework. The results include historical entries.
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
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, including Amd 1:2013)
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
Review a legal citation
- Identify the governing legislation and its application to the defined product.
- Check the full standard reference, edition and amendment set in the Official Journal act.
- Read any limitations, conditions and dates attached to that citation.
- Keep the publication record and citation record separately in the evidence file.
- Review later amending and withdrawing acts before relying on the reference.