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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 040 Date of Entry 08/14/2015 
FR Recognition Number 14-464
Standard
ISO ASTM  51649 Third edition 2015-03-15
Practice for dosimetry in an electron beam facility for radiation processing at energies between 300 keV and 25 MeV
Scope/Abstract
ISO/ASTM 51649:2015 outlines dosimetric procedures to be followed in installation qualification (IQ), operational qualification (OQ) and performance qualifications (PQ), and routine processing at electron beam facilities.
The electron beam energy range covered in this practice is between 300 keV and 25 MeV, although there are some discussions for other energies.
Dosimetry is only one component of a total quality assurance program for adherence to good manufacturing practices used in radiation processing applications. Other measures besides dosimetry may be required for specific applications such as health care product sterilization and food preservation.
ISO/ASTM 51649:2015 is one of a set of standards that provides recommendations for properly implementing and utilizing dosimetry in radiation processing. It is intended to be read in conjunction with ISO/ASTM 52628, "Practice for Dosimetry in Radiation Processing".
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*
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)]

ISO 11137-2 Third edition 2013-06-01, Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose

ISO 11137-3 First edition 2006-04-15, Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects


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 Contact
 Patrick Weixel
  FDA/OC/CDRH/OPEQ/OIDRH/DRH/
  301-796-5537
  Patrick.Weixel@fda.hhs.gov
Standards Development Organizations
ISO International Organization for Standardization https://www.iso.org/
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Sterility
*These are provided as examples and others may be applicable.
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