Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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063
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Date of Entry 09/09/2024
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FR Recognition Number
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14-605
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Standard | |
ISO 13004 First edition 2022-10 Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD |
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Identical AdoptionANSI AAMI ISO 13004:2022 Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD |
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Scope/AbstractThis 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. |
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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*
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. |
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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. |