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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Recognition 01/30/2014 
FR Recognition Number 14-411
Standard
ASTM ISO 51818 Third edition 2013-06-01
Practice for dosimetry in an electron beam facility for radiation processing at energies between 80 and 300 keV
Scope/Abstract
ISO/ASTM 51818:2013 covers dosimetric procedures to be followed in installation qualification, operational qualification and performance qualification (IQ, OQ, PQ), and routine processing at electron beam facilities to ensure that the product has been treated with an acceptable range of absorbed doses. Other procedures related to IQ, OQ, PQ, and routine product processing that may influence absorbed dose in the product are also discussed.

The electron beam energy range covered in ISO/ASTM 51818:2013 is between 80 and 300 keV, generally referred to as low energy. Dosimetry is only one component of a total quality assurance program for an irradiation facility. Other measures may be required for specific applications such as medical device sterilization and food preservation.

ISO/ASTM 51818:2013 is one of a set of standards that provides recommendations for properly implementing and utilizing dosimetry in radiation processing. It is intended to be read in conjunction with ASTM E2232.

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
ISO 11137-1 First edition 2006-04-15, Sterilization of health care products - Radiation- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013)].

ISO 11137-2 Third edition 2013-06-01, Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose.

ISO 11137-3 First edition 2006-04-15, Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects.
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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