Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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049
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Date of Entry 06/07/2018
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FR Recognition Number
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14-510
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Standard | |
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 |
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Identical AdoptionANSI AAMI ISO 11137-3:2017/(R)2023 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control |
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Scope/AbstractISO 11137-3:2017 gives guidance on meeting the requirements in ISO 11137-1 and ISO 11137-2 and in ISO/TS 13004 relating to dosimetry and its use in development, validation and routine control of a radiation sterilization process. |
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Extent of Recognition
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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. |
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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. |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |