ISO/ASTM 51608:2015
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Current
The latest, up-to-date edition.
Practice for dosimetry in an X-ray (bremsstrahlung) facility for radiation processing at energies between 50 keV and 7.5 MeV
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English
Published date
17-03-2015
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ISO/ASTM 51608:2015 outlines the dosimetric procedures to be followed during installation qualification, operational qualification, performance qualification and routine processing at an X-ray (bremsstrahlung) irradiator. Other procedures related to operational qualification, performance qualification and routine processing that may influence absorbed dose in the product are also discussed.
ISO/ASTM 51608:2015 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 Practice 52628, "Practice for Dosimetry in Radiation Processing".
In contrast to monoenergetic gamma radiation, the X-ray energy spectrum extends from low values (about 35 keV) up to the maximum energy of the electrons incident on the X-ray target.
| Committee |
ISO/TC 85
|
| DevelopmentNote |
Supersedes ASTM E 1608 (05/2002) Supersedes ISO 15567 (06/2002) Supersedes ISO/ASTM DIS 51608. (03/2015)
|
| DocumentType |
Standard
|
| Pages |
16
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| 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 |
| 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 |
| BS ISO 12749-4:2015 | Nuclear energy, nuclear technologies, and radiological protection. Vocabulary Dosimetry for 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 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 |
| 04/30108676 DC : 0 | ISO 51939 - PRACTICE FOR BLOOD IRRADIATION DOSIMETRY |
| 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) |
| ASTM E 2304 : 2003 : R2011 | Standard Practice for Use of a LiF Photo-Fluorescent Film Dosimetry System (Withdrawn 2020) |
| 04/30109485 DC : DRAFT AUG 2004 | ISO 51431 - PRACTICE FOR DOSIMETRY IN ELECTRON BEAM AND X-RAY (BREMSSTRAHLUNG) IRRADIATION FACILITIES FOR FOOD PROCESSING |
| 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 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 52303:2015 | Guide for absorbed-dose mapping in radiation processing facilities |
| ISO/ASTM 51707:2015 | Guide for estimation of measurement uncertainty in dosimetry for radiation processing |
| ISO 12749-4:2015 | Nuclear energy, nuclear technologies, and radiological protection — Vocabulary — Part 4: Dosimetry for radiation processing |
| ISO/ASTM 51940:2013 | Guide for dosimetry for sterile insects release programs |
| CSA Z11137-3 : 2007 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS |
| 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 51702:2013 | Practice for dosimetry in a gamma facility for radiation processing |
| 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) |
| 04/30108679 DC : DRAFT FEB 2004 | ISO 51940 - GUIDE FOR DOSIMETRY FOR STERILE INSECT RELEASE PROGRAMS |
| 04/30108670 DC : DRAFT FEB 2004 | ISO 51702 - PRACTICE FOR DOSIMETRY IN GAMMA IRRADIATION FACILITIES FOR RADIATION PROCESSING |
| 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 |
| ASTM E 2303 : 2015 : REDLINE | Standard Guide for Absorbed-Dose Mapping in Radiation Processing Facilities |
| 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 |
| 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 |
| CFR 21(PTS170-199) : 0 | FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 170-199 |
| 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 |
| 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 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 |
| 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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