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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 034 Date of Entry 01/30/2014 
FR Recognition Number 14-429
Standard
ISO ASTM  51275 Third edition 2013-06-01
Practice for use of a radiochromic film dosimetry system
Scope/Abstract
ISO/ASTM 51275:2013 is a practice for using radiochromic film dosimetry systems to measure absorbed dose in materials irradiated by photons or electrons in terms of absorbed dose to water.
Radiochromic film dosimetry systems are generally used as routine dosimetry systems.
The radiochromic film dosimeter is classified as a Type II dosimeter on the basis of the complex effect of influence quantities.
ISO/ASTM 51275:2013 is one of a set of standards that provides recommendations for properly implementing dosimetry in radiation processing, and describes a means of achieving compliance with the requirements of ASTM E2628 for a radiochromic film dosimetry system. It is intended to be read in conjunction with ASTM E2628.
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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