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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 059 Date of Entry 12/19/2022 
FR Recognition Number 14-582
Standard
ISO  TS 11137-4 First edition 2020-06
Sterilization of health care products - Radiation - Part 4: Guidance on process control
Identical Adoption
AAMI ISO TIR11137-4:2022
Sterilization of health care products - Radiation - Part 4: Guidance on process control
Scope/Abstract
This document provides additional guidance to that given in ISO 11137-3 on meeting the requirements specified in ISO 11137-1, ISO 11137-2 and ISO/TS 13004 for the establishment and control of a radiation sterilization process using gamma, electron beam, and X-irradiation.
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.
Relevant FDA Guidance and/or Supportive Publications*
1. AAMI TIR17:2017/(R)2020 Compatibility of materials subjected to sterilization.

2. AAMI TIR35:2016/(R)2021 Sterilization of health care products - Radiation sterilization - Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits.

3. AAMI TIR37:2013 Sterilization of health care products - Radiation - Guidance on sterilization of human tissue-based products.

4. AAMI TIR40:2018 Sterilization of health care products - Radiation - Guidance on dose setting utilizing a Modified Method 2.

5. AAMI TIR76:2021 Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose at a specified sterility assurance level: Method Vdmax SD-S.

6. ASTM E3270-21 Standard Guide for Operational Qualification of Gamma Irradiators.

7. ISO/ASTM 51631-20 Practice for use of calorimetric dosimetry systems for dose measurements and dosimetry system calibration in electron beams

8. ISO/ASTM 53239-21 Standard Guide for Using Statistical Process Control Principles for Routine Dosimetry in Radiation Processing.

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
 Paulo R. Laranjeira
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVB/
  301-796-9024
  Paulo.Laranjeira@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Groups (STG)
Sterility (primary)
Tissue Engineering
*These are provided as examples and others may be applicable.
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