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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 060 Date of Entry 05/29/2023 
FR Recognition Number 14-588
Standard
AAMI  /TIR17:2017/(R)2020
Compatibility of materials subjected to sterilization
Scope/Abstract
This technical information report provides guidance for health care product manufacturers in the qualification of polymeric materials, ceramics, and metals for use in health care products that are sterilized by the following modalities: a) radiation (gamma, electron beam, or x-ray); b) ethylene oxide; c) moist heat (steam); d) dry heat; e) hydrogen peroxide; f) nitrogen dioxide, g) peracetic acid vapor, h) liquid peracetic acid, and i) hydrogen peroxide-ozone. Annexes address the specific sterilization modality concerns.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§880.6100 Cabinet, Ethylene-Oxide Gas Aerator Class 2 FLI
§880.6860 Sterilizer, Ethylene-Oxide Gas Class 2 FLF
§880.6860 Sterilizer, Chemical Class 2 MLR
§880.6870 Sterilizer, Dry Heat Class 2 KMH
§880.6880 Sterilizer, Steam Class 2 FLE
§880.6880 Sterilizer Automated Loading System Class 2 PEC
New Technology Sterilizer (ie H2O2)
Relevant FDA Guidance and/or Supportive Publications*
1. ISO 11135 Second edition 2014-07 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)].

2. ISO 11137-1 First edition 2006-04 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2018)].

3. ISO 11137-2 Third edition 2013-06 [Including AMD1:2022] Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose [Including Amendment 1 (2022)].

4. ISO 11137-3 Second edition 2017-06 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control.

5. ISO/TS 11137-4 First edition 2020-06 Sterilization of health care products - Radiation - Part 4: Guidance on process control.

6. ISO 14937 Second edition 2009-10 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices.

7. ISO 17665-1 First edition 2006-08 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices.

8. ISO 22441 First edition 2022-08 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.

9. ANSI/AAMI ST40:2004/(R)2018 Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities.

10. Guidance on Premarket Notification 510(k) for Sterilizers Intended for Use in Health Care Facilities, issued March 1993.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Sreekanth Gutala
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVB/
  301-796-7007
  Sreekanth.Gutala@fda.hhs.gov
 Matthew Beckwith
  CDRH/OPEQ/OHTII/DHTIIC
  240-402-3393
  Matthew.Beckwith@fda.hhs.gov
Standards Development Organization
AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
FDA Specialty Task Group (STG)
Sterility
*These are provided as examples and others may be applicable.
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