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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 036 Date of Entry 07/09/2014 
FR Recognition Number 14-437
Standard
ISO ASTM  52701 First edition 2013-11-15 (R2020)
Guide for performance characterization of dosimeters and dosimetry systems for use in radiation processing
Scope/Abstract
ISO/ASTM 52701:2013 provides guidance on determining the performance characteristics of dosimeters and dosimetry systems used in radiation processing.
ISO/ASTM 52701:2013 describes the influence quantities that might affect the performance of dosimeters and dosimetry systems and that should be considered during dosimeter/dosimetry system characterization.
Users of ISO/ASTM 52701:2013 are directed to existing standards and literature for procedures to determine the effects from individual influence quantities and from combinations of more than one influence quantity.
Guidance is provided regarding the roles of the manufacturers, suppliers, and users in the characterization of dosimeters and dosimetry systems.
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*
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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