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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 059 Date of Entry 12/19/2022 
FR Recognition Number 14-580
Standard
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)]
Scope/Abstract
ISO 11137-2:2013 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10-6.

ISO 11137-2:2013 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.

ISO 11137-2:2013 defines product families for sterilization dose establishment and sterilization dose audit.
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.
Transition Period
FDA recognition of ISO 11137-2 Third edition 2013-06 [Rec# 14-409] will be superseded by recognition of ISO 11137-2 Third edition 2013-06 [Including AMD1:2022] [Rec# 14-580]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 14-409] until December 17, 2023. After this transition period, declarations of conformity to [Rec# 14-409] will not be accepted.
Relevant FDA Guidance and/or Supportive Publications*
1. AAMI TIR17:2017 Compatibility of materials subjected to sterilization.

2. AAMI TIR35:2016 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 Contact
 Patrick Weixel
  FDA/OC/CDRH/OPEQ/OIDRH/DRH/
  301-796-5537
  Patrick.Weixel@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Sterility
*These are provided as examples and others may be applicable.
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