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FDA Recognizes Standards to Advance Innovation in Sterilization Processes and Updates the Recognized Consensus Standards Database

The U.S. Food and Drug Administration (FDA) recently recognized the following sterilization standard and Technical Information Reports (TIRs) to help advance innovation in medical device sterilization processes. This latest update to the Recognized Consensus Standards database is known as “List 60,” and includes:

• new sterilization standards and reports:
  • ISO 22441:2022,
  • AAMI TIR104:2022, and
  • AAMI TIR17:2017/(R)2020
• new versions of recognized standards,
• revisions to some standards’ extent of recognition, and
• extended transition periods for two standards.

Facts About the List 60 Update

• The FDA recognized:
  • ISO 22441:2022 Sterilization of health care products — Low temperature vaporized hydrogen peroxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
  • Two Technical Information Reports associated with medical device sterilization:
    • AAMI TIR104:2022 Guidance on transferring health care products between radiation sterilization sources and
    • AAMI TIR17:2017/(R)2020 Compatibility of materials subjected to sterilization
• The complete recognition of ISO 22441:2022, AAMI TIR104:2022, and AAMI TIR17:2017/(R)2020 is part of our ongoing efforts to advance innovation in medical device sterilization processes, supports manufacturers’ use of low temperature vaporized hydrogen peroxide, and may streamline the premarket review process.
• Several changes in List 60 affect standards in the Accreditation Scheme for Conformity Assessment (ASCA) See the updated ASCA standards in the Recognized Consensus Standards database.
• According to the FDA’s guidance, Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices, the FDA may determine which new or revised standards are appropriate for meeting requirements for medical devices under the Federal Food, Drug, and Cosmetic Act.
• The Federal Register notice with modifications to the listing of recognized consensus standards for this List 60 will be published later in 2023, though manufacturers may now cite these new and revised standards in device submissions.

Questions?

If you have questions about standards, contact the Division of Industry and Consumer Education.