| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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052
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Date of Entry 07/15/2019
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FR Recognition Number
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14-528
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| Standard | |
ISO 11137-1 First edition 2006-04-15
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)] |
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Identical AdoptionANSI AAMI ISO 11137-1:2006/(R)2015
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 (2019)] |
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Scope/AbstractISO 11137-1:2006 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. Although the scope of ISO 11137-1:2006 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment.
ISO 11137-1:2006 covers radiation processes employing irradiators using the radionuclide 60Co or 137Cs, a beam from an electron generator or a beam from an X-ray generator.
ISO 11137-1:2006 does not:
-specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease;
-detail specified requirements for designating a medical device as sterile;
-specify a quality management system for the control of all stages of production of medical devices;
-specify requirements for occupational safety associated with the design and operation of irradiation facilities;
-specify requirements for the sterilization of used or reprocessed devices. |
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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 Contacts
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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. |
