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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 063 Date of Entry 09/09/2024 
FR Recognition Number 14-605
Standard
ISO  13004 First edition 2022-10
Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD
Identical Adoption
ANSI AAMI ISO 13004:2022
Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD
Scope/Abstract
This document describes a method for substantiating a selected sterilization dose of 17,5 kGy, 20 kGy, 22,5 kGy, 27,5 kGy, 30 kGy, 32,5 kGy or 35 kGy that achieves a sterility assurance level (SAL) of 10^-6 or less for radiation sterilization of health care products. This document also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose.

NOTE 1 Selection and substantiation of the sterilization dose is used to meet the requirements for establishing the sterilization dose within process definition in ISO 11137-1.

This document does not apply to other sterilization doses than the substantiation of a selected sterilization dose of 17,5 kGy, 20 kGy, 22,5 kGy, 27,5 kGy, 30 kGy, 32,5 kGy or 35 kGy. The method is not used for the substantiation of a selected sterilization dose if the average bioburden of the entire product item exceeds the limit specified for the selected sterilization dose (see Table 3).

NOTE 2 The methods for substantiation of selected sterilization doses of 25 kGy and 15 kGy are not included in this document. They are described in ISO 11137-2.

If the decision is made to use this method of sterilization dose establishment, the method is intended to be followed in accordance with the requirements (shall) and guidance (should) stipulated herein.
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.
Relevant FDA Guidance and/or Supportive Publications*
Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile - Guidance for Industry and Food and Drug Administration Staff, issued January 2024.

Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products - FDA Guidance for Industry, issued November 1994.

Medical Device Sterilization Town Hall: FDA's Modifications Guidances and the Use of Device Master Files in Reviews. February 29, 2024. https://www.fda.gov/medical-devices/medical-devices-news-and-events/medical-device-sterilization-town-hall-fdas-modifications-guidances-and-use-device-master-files.

Center for Devices and Radiological Health Radiation Sterilization Master File Pilot Program. FDA. Federal Register. Vol. 88, No. 70, 22040-22043.

ISO 11137-1 First edition 2006-04 Sterilization of health care products - Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.

ISO 11737-1 Third edition 2018-01 [Including AMD1:2021] Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products.

ISO 11737-2 Third edition 2019-12 Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process.

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
 Sreekanth Gutala
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVB/
  301-796-7007
  Sreekanth.Gutala@fda.hhs.gov
 Paulo R. Laranjeira
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVB/
  301-796-9024
  Paulo.Laranjeira@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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