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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 040 Date of Entry 08/14/2015 
FR Recognition Number 14-465
Standard
ISO ASTM  51707 Third edition 2015-03-15
Guide for estimating uncertainties in dosimetry for radiation processing
Scope/Abstract
ISO/ASTM 51707:2015 provides guidance on the use of concepts described in the JCGM Evaluation of Measurement Data ? Guide to the Expression of Uncertainty in Measurement (GUM) to estimate the uncertainties in the measurement of absorbed dose in radiation processing.
Methods are given for identifying, evaluating and estimating the components of measurement uncertainty associated with the use of dosimetry systems and for calculating combined standard measurement uncertainty and expanded (overall) uncertainty of dose measurements based on the GUM methodology.
Examples are given on how to develop a measurement uncertainty budget and a statement of uncertainty.
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


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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