ISO/ASTM 51818:2013
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
02-07-2020
English
15-05-2013
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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
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.
| DevelopmentNote |
Supersedes ASTM E 1818 (05/2002) Supersedes ISO 15573 (06/2002) Supersedes ISO/ASTM DIS 51818. (05/2013)
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| DocumentType |
Standard
|
| Pages |
13
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| PublisherName |
International Organization for Standardization
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| Status |
Withdrawn
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| SupersededBy | |
| Supersedes |
| 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 |
| 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 |
| 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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