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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 055 Date of Entry 12/21/2020 
FR Recognition Number 14-552
Standard
ISO ASTM  51818 Fourth edition 2020-06
Practice for dosimetry in an electron beam facility for radiation processing at energies between 80 and 300 keV
Scope/Abstract
This practice covers dosimetric procedures to be followed in installation qualification, operational qualification and performance qualification (IQ, OQ, PQ), and routine processing at electron beam facilities to ensure that the product has been treated with an acceptable range of absorbed doses. Other procedures related to IQ, OQ, PQ, and routine product processing that may influence absorbed dose in the product are also discussed.
The electron beam energy range covered in this practice is between 80 and 300 keV, generally referred to as low energy.
Dosimetry is only one component of a total quality assurance program for an irradiation facility. Other measures may be required for specific applications such as medical device sterilization and food preservation.
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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