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ASTM E 2303 : 2015 : REDLINE

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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Standard Guide for Absorbed-Dose Mapping in Radiation Processing Facilities

Superseded date

24-01-2024

Published date

05-06-2015

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CONTAINED IN VOL. 12.02, 2013 Gives guidance in determining absorbed-dose distributions in products, materials or substances irradiated in gamma, X-ray (bremsstrahlung) and electron beam facilities.

Committee
E 61
DocumentType
Redline
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy

1.1This document provides guidance in determining absorbed-dose distributions (mapping) in products, materials or substances irradiated in gamma, X-ray (bremsstrahlung) and electron beam facilities.

Note 1:For irradiation of food and the radiation sterilization of health care products, specific ISO and ISO/ASTM standards containing dose mapping requirements exist. See ISO/ASTM Practices 51431, 51608, 51649, 51702 and 51818 and ISO 11137-1. Regarding the radiation sterilization of health care products, in those areas covered by ISO 11137-1, that standard takes precedence.

1.2This guide is one of a set of standards that provides recommendations for properly implementing dosimetry in radiation processing. it is intended to be read in conjunction with ISO/ASTM 52628.

1.3Methods of analyzing the dose map data are described. Examples are provided of statistical methods that may be used to analyze dose map data.

1.4Dose mapping for bulk flow processing and fluid streams is not discussed.

1.5Dosimetry is an element of a total quality management system for an irradiation facility. Other controls besides dosimetry may be required for specific applications such as medical device sterilization and food preservation.

1.6This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory requirements prior to use.

13/30264511 DC : 0 BS ISO/ASTM 52628 - STANDARD PRACTICE FOR DOSIMETRY IN RADIATION PROCESSING
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
12/30256719 DC : 0 BS ISO/ASTM 51940 - GUIDE FOR DOSIMETRY FOR STERILE INSECTS RELEASE PROGRAMS
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
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
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
ASTM E 2449 : 2005 Standard Guide for Irradiation of Pre-packaged Processed Meat and Poultry Products to Control Pathogens and Other Microorganisms
IEC 60544-1:2013 Electrical insulating materials - Determination of the effects of ionizing radiation - Part 1: Radiation interaction and dosimetry
ISO/ASTM 51940:2013 Guide for dosimetry for sterile insects release programs
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
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
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))
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 2449 : 2005 : R2013 Standard Guide for Irradiation of Pre-packaged Processed Meat and Poultry Products to Control Pathogens and Other Microorganisms (Withdrawn 2016)
CSA Z11137-3 : 2007 : R2016 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS
ISO/ASTM 51702:2013 Practice for dosimetry in a gamma facility for radiation processing
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
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 51608:2015 Practice for dosimetry in an X-ray (bremsstrahlung) facility for radiation processing at energies between 50 keV and 7.5 MeV
ISO/ASTM 51431:2005 Practice for dosimetry in electron beam and X-ray (bremsstrahlung) irradiation facilities for food processing
ASTM E 170 : 2017 : REDLINE Standard Terminology Relating to Radiation Measurements and Dosimetry
ISO/IEC Guide 99:2007 International vocabulary of metrology Basic and general concepts and associated terms (VIM)
ASTM E 2232 : 2016 : REDLINE Standard Guide for Selection and Use of Mathematical Methods for Calculating Absorbed Dose in Radiation Processing Applications
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 51204:2004 Practice for dosimetry in gamma irradiation facilities for food processing
ISO/IEC Guide 98-3:2008 Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)

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