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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 14-430
Standard
ISO ASTM  51607 Third edition 2013-06-01
Practice for use of an alanine-EPR dosimery system
Scope/Abstract
ISO/ASTM 51607:2013 covers dosimeter materials, instrumentation, and procedures for using the alanine-EPR dosimetry system for measuring the absorbed dose in the photon and electron radiation processing of materials. The system is based on electron paramagnetic resonance (EPR) spectroscopy of free radicals derived from the amino acid alanine.
The alanine dosimeter is classified as a type I dosimeter as it is affected by individual influence quantities in a welldefined way that can be expressed in terms of independent correction factors. The alanine dosimeter may be used in either a reference standard dosimetry system or in a routine dosimetry system.
ISO/ASTM 51607:2013 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 alanine dosimetry system. It is intended to be read in conjunction with ASTM E2628.
Extent of Recognition
Complete standard
Rationale for Recognition
Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants - Guidance for Industry and FDA Reviewers, Issued January 2000.
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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