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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 054 Date of Entry 07/06/2020 
FR Recognition Number 14-545
Standard
ISO ASTM  51276 Fourth edition 2019-08
Practice for use of a polymethylmethacrylate dosimetry system
Scope/Abstract
1.1 This is a practice for using polymethylmethacrylate (PMMA) dosimetry systems to measure absorbed dose in materials irradiated by photons or electrons in terms of absorbed dose to water. The PMMA dosimetry system is generally used as a routine dosimetry system.
1.2 The PMMA dosimeter is classified as a Type II dosim-eter on the basis of the complex effect of influence quantities (see ISO/ASTM Practice 52628).
1.3 This document 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 ISO/ASTM 52628 "Practice for Dosimetry in Radiation Processing" for a PMMA dosimetry system. It is intended to be read in conjunction with ISO/ASTM Practice 52628.
1.4 This practice covers the use of PMMA dosimetry systems under the following conditions:
1.4.1 the absorbed dose range is 0.1 kGy to 150 kGy.
1.4.2 the absorbed dose rate is1×10-2 to1×107 Gy·s0-1.
1.4.3 the photon energy range is 0.1 to 25 MeV.
1.4.4 the electron energy range is 3 to 25 MeV.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
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 Contacts
 Sreekanth Gutala
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVB/
  301-796-7007
  Sreekanth.Gutala@fda.hhs.gov
 Paulo R. Laranjeira
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVB/
  301-796-9024
  Paulo.Laranjeira@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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