Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
|
059
|
Date of Entry 12/19/2022
|
FR Recognition Number
|
14-580
|
Standard | |
ISO 11137-2 Third edition 2013-06 [Including AMD1:2022] Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose [Including Amendment 1 (2022)] |
|
Scope/AbstractISO 11137-2:2013 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10-6.
ISO 11137-2:2013 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.
ISO 11137-2:2013 defines product families for sterilization dose establishment and sterilization dose audit. |
|
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. |
|
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. |
|
FDA Technical Contacts
|
Standards Development Organization
|
FDA Specialty Task Group (STG)
|
*These are provided as examples and others may be applicable. |