| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
064
|
Date of Entry 05/26/2025
|
|
FR Recognition Number
|
14-611
|
| Standard | |
ISO 11137-1 Second edition 2025-04
Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
|
Scope/Abstract1.1. This document specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices.
NOTE Although the scope is limited to medical devices, this document can be applicable to other products and equipment.
This document covers radiation processes employing irradiators using:
a) the radionuclide 60Co or 137Cs;
b) a beam from an electron generator; or
c) a beam from an X-ray generator.
1.2. This document is not applicable to processes for inactivating viruses or the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.
NOTE For information on such processes, see ISO 22442-1, ISO 22442-2, ISO 22442-3, ISO 13022 and ICH Q5A.
1.2.1. This document does not specify requirements for designating a medical device as sterile.
NOTE Regional and national requirements can designate medical devices as sterile. See, for example, EN 556-1 or ANSI/AAMI ST67.
1.2.2. This document does not specify a quality management system for the control of all stages of production of medical devices.
NOTE It is not a requirement of this document to have a complete quality management system during manufacture, but the elements of a quality management system that are the minimum necessary to control the sterilization process are normatively referenced at appropriate places in the text (see, in particular, Clause 4). Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production of medical devices, including the sterilization process. Regional and national regulations for the provision of medical devices can require implementation of a complete quality management system and the assessment of that system by a third party.
1.2.3. This document does not require that biological indicators be used for validation or monitoring of radiation sterilization, nor does it require that a pharmacopoeia test for sterility be carried out for product release.
1.2.4. This document does not specify requirements for occupational safety associated with the design and operation of irradiation facilities.
NOTE Regulations on safety requirements for occupational safety related to radiation can exist in some countries.
1.2.5. This document does not specify requirements for the sterilization of used or reprocessed devices.
|
|
| Extent of Recognition
|
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 11137-1 First edition 2006-04-15 [Rec# 14-528] will be superseded by recognition of ISO 11137-1 Second edition 2025-04 [Rec# 14-611]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 14-528] until July 4, 2027. After this transition period, declarations of conformity to [Rec# 14-528] will not be accepted. |
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| 21 CFR 801 Labeling |
| 21 CFR 820.3 Definitions |
|
Relevant FDA Guidance and/or Supportive Publications*
1. AAMI TIR17:2024 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/(R)2022 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 E3270-21e1 Standard Guide for Operational Qualification of Gamma Irradiators.
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
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
