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  • ISO/ASTM 51649:2015

    Current The latest, up-to-date edition.

    Practice for dosimetry in an electron beam facility for radiation processing at energies between 300 keV and 25 MeV

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

    Language(s):  English

    Published date:  17-03-2015

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO/ASTM 51649:2015 outlines dosimetric procedures to be followed in installation qualification (IQ), operational qualification (OQ) and performance qualifications (PQ), and routine processing at electron beam facilities.

    The electron beam energy range covered in this practice is between 300 keV and 25 MeV, although there are some discussions for other energies.

    Dosimetry is only one component of a total quality assurance program for adherence to good manufacturing practices used in radiation processing applications. Other measures besides dosimetry may be required for specific applications such as health care product sterilization and food preservation.

    ISO/ASTM 51649:2015 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 ISO/ASTM 52628, "Practice for Dosimetry in Radiation Processing".

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

    Development Note Supersedes ASTM E 1649 (05/2002) Supersedes ISO 15569 (06/2002) Supersedes ISO/ASTM DIS 51649. (03/2015)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Current
    Supersedes

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

    ASTM E 2381 : 2004 : R2010 Standard Guide for Dosimetry In Radiation Processing of Fluidized Beds and Fluid Streams (Withdrawn 2016)
    13/30264511 DC : 0 BS ISO/ASTM 52628 - STANDARD PRACTICE FOR DOSIMETRY IN RADIATION PROCESSING
    14/30286829 DC : 0 BS ISO 12749-4 - NUCLEAR ENERGY, NUCLEAR TECHNOLOGIES, AND RADIOLOGICAL PROTECTION - VOCABULARY - PART 4: DOSIMETRY FOR RADIATION PROCESSING
    04/30108679 DC : DRAFT FEB 2004 ISO 51940 - GUIDE FOR DOSIMETRY FOR STERILE INSECT RELEASE PROGRAMS
    13/30281229 DC : 0 BS ISO 51956 - PRACTICE FOR USE OF THERMOLUMINESCENCE DOSIMETRY (TLD) SYSTEMS FOR RADIATION PROCESSING
    CSA Z11137-3 : 2007 : R2012 : FR STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS
    CAN/CSA-ISO/TS 16775:17 Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2 (Adopted ISO technical specification 16775:2014, first edition, 2014-05-15)
    S.R. CEN ISO/TS 16775:2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 (ISO/TS 16775:2014)
    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
    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
    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)
    CEN ISO/TS 16775:2014 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2014)
    04/30081279 DC : DRAFT MAY 2004 BS EN ISO 11137-3 - STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS
    12/30256719 DC : 0 BS ISO/ASTM 51940 - GUIDE FOR DOSIMETRY FOR STERILE INSECTS RELEASE PROGRAMS
    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
    PD CEN ISO/TS 16775:2014 Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2
    BS 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
    CSA Z11137-3 : 2007 : R2012 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS
    ISO/ASTM 51539:2013 Guide for use of radiation-sensitive indicators
    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)
    04/30108670 DC : DRAFT FEB 2004 ISO 51702 - PRACTICE FOR DOSIMETRY IN GAMMA IRRADIATION FACILITIES FOR RADIATION PROCESSING
    ASTM E 2304 : 2003 : R2011 Standard Practice for Use of a LiF Photo-Fluorescent Film Dosimetry System (Withdrawn 2020)
    ISO/ASTM 51940:2013 Guide for dosimetry for sterile insects release programs
    BS ISO 12749-4:2015 Nuclear energy, nuclear technologies, and radiological protection. Vocabulary Dosimetry for radiation processing
    ASTM E 2304 : 2003 Standard Practice for Use of a Lif Photo-Fluorescent Film Dosimetry System
    14/30315832 DC : 0 BS ISO/ASTM 52303 - GUIDE FOR ABSORBED-DOSE MAPPING IN RADIATION PROCESSING FACILITIES
    04/30109485 DC : DRAFT AUG 2004 ISO 51431 - PRACTICE FOR DOSIMETRY IN ELECTRON BEAM AND X-RAY (BREMSSTRAHLUNG) IRRADIATION FACILITIES FOR FOOD PROCESSING
    04/30118695 DC : DRAFT AUG 2004 BS ISO ASTM 51539 - GUIDE FOR USE OF RADIATION-SENSITIVE INDICATORS
    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
    ASTM E 2381 : 2004 Standard Guide for Dosimetry In Radiation Processing of Fluidized Beds and Fluid Streams
    ISO/ASTM 51707:2015 Guide for estimation of measurement uncertainty in dosimetry for radiation processing
    ASTM E 3083 : 2017 Standard Terminology Relating to Radiation Processing: Dosimetry and Applications
    ISO 12749-4:2015 Nuclear energy, nuclear technologies, and radiological protection Vocabulary Part 4: Dosimetry for radiation processing
    CSA Z11137-3 : 2007 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS
    04/30109483 DC : DRAFT AUG 2004 BS ISO ASTM 51608 - PRACTICE FOR DOSIMETRY IN AN X-RAY (BREMSSTRAHLUNG) FACILITY FOR RADIATION PROCESSING
    12/30273487 DC : 0 BS ISO 51818 - PRACTICE FOR DOSIMETRY IN AN ELECTRON BEAM FACILITY FOR RADIATION PROCESSING AT ENERGIES BETWEEN 80 AND 300 KEV
    ASTM E 2303 : 2015 : REDLINE Standard Guide for Absorbed-Dose Mapping in Radiation Processing Facilities
    CSA Z11137-3 :2007 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS
    ISO/ASTM 51818:2013 Practice for dosimetry in an electron beam facility for radiation processing at energies between 80 and 300 keV
    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 TIR16775:2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2
    ANSI/AAMI/ISO 11137-3:2017 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS OF DEVELOPMENT, VALIDATION AND ROUTINE CONTROL
    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/ASTM 51631:2013 Practice for use of calorimetric dosimetry systems for electron beam dose measurements and dosimetery system calibrations
    ISO/TS 16775:2014 Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2
    ISO 11137-3:2017 Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
    UNI CEN ISO/TS 16775 : 2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2
    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)
    03/300863 DC : DRAFT JAN 2003 ISO/ASTM 51631 - USE OF COLORIMETRIC DOSIMETRY SYSTEMS FOR ELECTRON BEAM DOSE MEASUREMENTS AND ROUTINE DOSIMETER CALIBRATION
    12/30251709 DC : 0 BS ISO/ASTM 51631 - PRACTICE FOR USE OF CALORIMETRIC DOSIMETRY SYSTEMS FOR ELECTRON BEAM DOSE MEASUREMENTS AND DOSIMETER CALIBRATIONS
    12/30259937 DC : 0 BS EN 50544-1 - ELECTRICAL INSULATING MATERIALS - DETERMINATION OF THE EFFECTS OF IONIZING RADIATION - PART 1: RADIATION INTERACTION AND DOSIMETRY
    CSA Z11137-3 : 2007 : R2016 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS
    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 51956:2013 Practice for use of a thermoluminescence-dosimetry system (TLD system) for radiation processing
    ISO/ASTM 51702:2013 Practice for dosimetry in a gamma facility for radiation processing
    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 51702:2013 Practice for dosimetry in a gamma facility for radiation processing
    ISO/ASTM 51818:2013 Practice for dosimetry in an electron beam facility for radiation processing at energies between 80 and 300 keV
    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
    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 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 51539:2013 Guide for use of radiation-sensitive indicators
    ISO/ASTM 52701:2013 Guide for performance characterization of dosimeters and dosimetry systems for use in radiation processing
    ISO 11137-3:2017 Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
    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 10012:2003 Measurement management systems — Requirements for measurement processes and measuring equipment
    ISO/ASTM 51707:2015 Guide for estimation of measurement uncertainty in dosimetry for radiation processing
    ISO/ASTM 52628:2013 Standard practice for dosimetry in radiation processing
    ASTM E 2303 : 2015 : REDLINE Standard Guide for Absorbed-Dose Mapping in Radiation Processing Facilities
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