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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 043 Date of Entry 06/27/2016 
FR Recognition Number 14-483
Standard
ISO ASTM  52303 First edition 2015-07-15
Guide for absorbed-dose mapping in radiation processing facilities
Scope/Abstract
ISO/ASTM 52303:2015 provides guidance in determining absorbed-dose distributions (mapping) in products, materials or substances irradiated in gamma, X-ray (bremsstrahlung) and electron beam facilities.
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
 Johannetsy Avillan
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVC/
  --
  Johannetsy.Avillan@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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