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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 052 Date of Entry 07/15/2019 
FR Recognition Number 14-528
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)]
U.S. Identical Adoption
ANSI 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)]
Scope/Abstract
ISO 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.

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FDA recognition of ISO 11137-1 First edition 2006-04-15 and Amendment 1 [Rec# 14-428] will be superseded by recognition of ISO 11137-1 First edition 2006-04-15 Amendment 1 and Amendment 2 [Rec# 14-528]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 14-428] until July 26, 2020. After this transition period, declarations of conformity to [Rec# 14-428] will not be accepted.
Relevant FDA Guidance and/or Supportive Publications*
AAMI TIR17:2008 Compatibility of materials subjected to sterilization.

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

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

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