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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 031 Date of Recognition 08/06/2013 
FR Recognition Number 14-382
Standard
ASTM ISO 51276 Second edition 2012-07-15
Practice for use of a polymethylmethacrylate dosimetry system
Scope/Abstract
ISO/ASTM 51276:2012 provides recommendations for properly implementing dosimetry in radiation processing.

ISO/ASTM 51276:2012 specifies 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 classified as a routine dosimetry system. The PMMA dosimeter is classified as a Type II dosimeter on the basis of the complex effect of influence quantities.

ISO/ASTM 51276:2012 is applicable to the use of PMMA dosimetry systems under the following conditions:

- the absorbed dose range is 0,1 kGy to 150 kGy;

- the absorbed dose rate is 1 x 10−2 Gy·s−1 to 1 x 107 Gy·s−1;

- the photon energy range is 0,1 MeV to 25 MeV;

- the electron energy range is 3 MeV to 25 MeV.

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
There is no relevant guidance developed at this time.
FDA Technical Contact
 Patrick Weixel
  FDA/OMPT/CDRH/OIR/DRH/
  301-796-5537
  Patrick.Weixel@fda.hhs.gov
Standards Development Organizations
ASTM ASTM International http://www.astm.org/
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Sterility
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