ISO/ASTM 51649:2015
Current
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
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Language(s)
English
Published date
17-03-2015
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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".
| Committee |
ISO/TC 85
|
| 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 |
| ASTM E 2381 : 2004 : R2010 | Standard Guide for Dosimetry In Radiation Processing of Fluidized Beds and Fluid Streams (Withdrawn 2016) |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 |
| 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 |
| 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 |
| ASTM E 2303 : 2015 : REDLINE | Standard Guide for Absorbed-Dose Mapping in Radiation Processing Facilities |
| 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 | 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 |
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