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  • ISO/ASTM 51818:2013

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    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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    Practice for dosimetry in an electron beam facility for radiation processing at energies between 80 and 300 keV

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Withdrawn date:  02-07-2020

    Language(s):  English

    Published date:  15-05-2013

    Publisher:  International Organization for Standardization

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    Table of Contents - (Show below) - (Hide below)

    1 Scope
    2 Referenced documents
    3 Terminology
    4 Significance and use
    5 Dosimetry systems
    6 Calibration of the dosimetry system
    7 Installation and operational qualification
    8 Performance qualification
    9 Throughput calculations
    10 Measurement uncertainty
    11 Certification
    12 Keywords
    Annexes
    Bibliography

    Abstract - (Show below) - (Hide below)

    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.

    General Product Information - (Show below) - (Hide below)

    Development Note Supersedes ASTM E 1818 (05/2002) Supersedes ISO 15573 (06/2002) Supersedes ISO/ASTM DIS 51818. (05/2013)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Withdrawn
    Superseded By
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    ASTM E 2303 : 2015 : REDLINE Standard Guide for Absorbed-Dose Mapping in Radiation Processing Facilities
    14/30286829 DC : 0 BS ISO 12749-4 - NUCLEAR ENERGY, NUCLEAR TECHNOLOGIES, AND RADIOLOGICAL PROTECTION - VOCABULARY - PART 4: DOSIMETRY FOR RADIATION PROCESSING
    DIN EN ISO 11137-3:2015-08 (Draft) STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS OF DEVELOPMENT, VALIDATION AND ROUTINE CONTROL (ISO 11137-3:2017)
    13/30264511 DC : 0 BS ISO/ASTM 52628 - STANDARD PRACTICE FOR DOSIMETRY IN RADIATION PROCESSING
    14/30303365 DC : 0 BS ISO/ASTM 51649 - PRACTICE FOR DOSIMETRY IN AN ELECTRON BEAM FACILITY FOR RADIATION PROCESSING AT ENERGIES BETWEEN 300 KEV AND 25 MEV
    15/30282559 DC : 0 BS EN ISO 11137-3 - STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS OF DEVELOPMENT, VALIDATION AND ROUTINE CONTROL
    BS EN 60544-1:2013 Electrical insulating materials. Determination of the effects of ionizing radiation Radiation interaction and dosimetry
    AAMI TIR 29:2012(R2017) GUIDE FOR PROCESS CHARACTERIZATION AND CONTROL IN RADIATION STERILIZATION OF MEDICAL DEVICES
    AAMI TIR 29:2012 GUIDE FOR PROCESS CHARACTERIZATION AND CONTROL IN RADIATION STERILIZATION OF MEDICAL DEVICES
    ISO/ASTM 52628:2013 Standard practice for dosimetry in radiation processing
    IEC 60544-1:2013 Electrical insulating materials - Determination of the effects of ionizing radiation - Part 1: Radiation interaction and dosimetry
    I.S. EN ISO 11137-3:2017 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS OF DEVELOPMENT, VALIDATION AND ROUTINE CONTROL (ISO 11137-3:2017)
    ASTM E 2304 : 2003 : R2011 Standard Practice for Use of a LiF Photo-Fluorescent Film Dosimetry System (Withdrawn 2020)
    BS ISO 12749-4:2015 Nuclear energy, nuclear technologies, and radiological protection. Vocabulary Dosimetry for radiation processing
    14/30315832 DC : 0 BS ISO/ASTM 52303 - GUIDE FOR ABSORBED-DOSE MAPPING IN RADIATION PROCESSING FACILITIES
    CEI EN 60544-1 : 2014 ELECTRICAL INSULATING MATERIALS - DETERMINATION OF THE EFFECTS OF IONIZING RADIATION - PART 1: RADIATION INTERACTION AND DOSIMETRY
    12/30256716 DC : 0 BS ISO/ASTM 51702 - PRACTICE FOR DOSIMETRY IN A GAMMA IRRADIATION FACILITY FOR RADIATION PROCESSING
    CAN/CSA-ISO 11137-3:17 Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control (Adopted ISO 11137-3:2017, second edition, 2017-06)
    ISO/ASTM 52303:2015 Guide for absorbed-dose mapping in radiation processing facilities
    ISO 12749-4:2015 Nuclear energy, nuclear technologies, and radiological protection Vocabulary Part 4: Dosimetry for radiation processing
    ASTM E 2304 : 2003 Standard Practice for Use of a Lif Photo-Fluorescent Film Dosimetry System
    ASTM E 2381 : 2004 : R2010 Standard Guide for Dosimetry In Radiation Processing of Fluidized Beds and Fluid Streams (Withdrawn 2016)
    I.S. EN 60544-1:2013 ELECTRICAL INSULATING MATERIALS - DETERMINATION OF THE EFFECTS OF IONIZING RADIATION - PART 1: RADIATION INTERACTION AND DOSIMETRY (IEC 60544-1:2013 (EQV))
    ANSI/AAMI/ISO 11137-3:2017 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS OF DEVELOPMENT, VALIDATION AND ROUTINE CONTROL
    ISO/ASTM 51608:2015 Practice for dosimetry in an X-ray (bremsstrahlung) facility for radiation processing at energies between 50 keV and 7.5 MeV
    ASTM D 1879 : 2006 Standard Practice for Exposure of Adhesive Specimens to Ionizing Radiation
    ASTM D 1879 : 2006 : R2014 Standard Practice for Exposure of Adhesive Specimens to Ionizing Radiation
    ISO 11137-3:2017 Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
    EN ISO 11137-3:2017 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017)
    12/30259937 DC : 0 BS EN 50544-1 - ELECTRICAL INSULATING MATERIALS - DETERMINATION OF THE EFFECTS OF IONIZING RADIATION - PART 1: RADIATION INTERACTION AND DOSIMETRY
    ASTM F 1356 : 2016 : REDLINE Standard Guide for Irradiation of Fresh, Frozen or Processed Meat and Poultry to Control Pathogens and Other Microorganisms
    ISO/ASTM 51702:2013 Practice for dosimetry in a gamma facility for radiation processing
    ISO/ASTM 51649:2015 Practice for dosimetry in an electron beam facility for radiation processing at energies between 300 keV and 25 MeV
    ASTM E 2381 : 2004 Standard Guide for Dosimetry In Radiation Processing of Fluidized Beds and Fluid Streams
    BS EN ISO 11137-3:2017 Sterilization of health care products. Radiation Guidance on dosimetric aspects of development, validation and routine control
    EN 60544-1:2013 Electrical insulating materials - Determination of the effects of ionizing radiation - Part 1: Radiation interaction and dosimetry

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
    ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    ISO/ASTM 51650:2013 Practice for use of a cellulose triacetate dosimetry system
    ISO/ASTM 51261:2013 Practice for calibration of routine dosimetry systems for radiation processing
    ISO/ASTM 51275:2013 Practice for use of a radiochromic film dosimetry system
    ASTM F 1356 : 2016 : REDLINE Standard Guide for Irradiation of Fresh, Frozen or Processed Meat and Poultry to Control Pathogens and Other Microorganisms
    ASTM E 170 : 2017 : REDLINE Standard Terminology Relating to Radiation Measurements and Dosimetry
    ASTM E 2232 : 2016 : REDLINE Standard Guide for Selection and Use of Mathematical Methods for Calculating Absorbed Dose in Radiation Processing Applications
    ISO/ASTM 51607:2013 Practice for use of the alanine-EPR dosimetry system
    ISO 14470:2011 Food irradiation — Requirements for the development, validation and routine control of the process of irradiation using ionizing radiation for the treatment of food
    ISO/ASTM 51649:2015 Practice for dosimetry in an electron beam facility for radiation processing at energies between 300 keV and 25 MeV
    ISO/ASTM 51707:2015 Guide for estimation of measurement uncertainty in dosimetry for radiation processing
    ASTM E 2303 : 2015 : REDLINE Standard Guide for Absorbed-Dose Mapping in Radiation Processing Facilities
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