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

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Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English

Published date

17-03-2015

Publisher

International Organization for Standardization

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".

DevelopmentNote	Supersedes ASTM E 1649 (05/2002) Supersedes ISO 15569 (06/2002) Supersedes ISO/ASTM DIS 51649. (03/2015)
DocumentType	Standard
Pages	35
PublisherName	International Organization for Standardization
Status	Current
Supersedes	ISO/ASTM 51649:2005 ISO 15569:1998 ASTM E 1649 : 2015

ASTM E 2381 : 2004 : R2010	Standard Guide for Dosimetry In Radiation Processing of Fluidized Beds and Fluid Streams (Withdrawn 2016)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

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