ISO/TC 85/SC 2/WG 13 - Monitoring and dosimetry for internal exposure

This document specifies general requirements for proficiency tests that are offered to in vivo bioassay measurement facilities operating a whole-body counter (WBC) or partial body counter (PBC) for monitoring of persons. It specifies minimum requirements for proficiency testing applicable to dosimetry laboratories that have dedicated facilities for in vivo monitoring and where accreditation is required as part of providing the service. It also provides general requirements for proficiency testing that may include a larger group of non-accredited laboratories that may perform measurements as part of worker surveillance or in response to an emergency. This document covers proficiency tests that involve only the quantification of radionuclides and tests that require the identification of radionuclides and their activity. This document does not define specific requirements on administrative aspects of proficiency testing, such as shipping and finance, that may be the subject of national or international regulation.

This document specifies the requirements for personal contamination monitoring and dose assessment following wounds involving radioactive materials. It includes requirements for the direct monitoring at the wound site, monitoring of uptake of radionuclides into the body and assessment of local and systemic doses following the wound event. It does not address: — details of monitoring and assessment methods for specific radionuclides; — monitoring and dose assessment for materials in contact with intact skin or pre-existing wounds, including hot particles; — therapeutic protocols. However, the responsible entity needs to address the requirements for decontamination and decorporation treatments if appropriate.

This document specifies the minimum requirements for the design of professional programmes to monitor workers exposed to a risk of ingestion to uranium compounds. This document establishes principles for the development of compatible goals and requirements for monitoring programmes and dose assessment for workers occupationally exposed to internal contamination. It establishes procedures and assumptions for risk analysis, monitoring programmes and the standardized interpretation of monitoring data in order to achieve acceptable levels of reliability for uranium and its compounds. It sets limits for the applicability of the procedures in respect to dose levels above which more sophisticated methods need to be applied. This document addresses those circumstances when exposure could be constrained by either radiological or chemical toxicity concerns. This document addresses, for ingestion of uranium and its compounds, the following items: a) purposes of monitoring and monitoring programmes; b) description of the different categories of monitoring programmes; c) suitable methods for monitoring and criteria for their selection; d) information that is collected for the design of a monitoring programme; e) procedures for dose assessment based on reference levels for special monitoring programmes; f) criteria for determining the significance of monitoring results; g) uncertainties arising from dose assessment and interpretation of bioassays data; h) reporting/documentation; i) quality assurance; j) record keeping requirements. It is not applicable to the following items: a) detailed descriptions of measuring methods and techniques for uranium; b) modelling for the improvement of internal dosimetry; c) potential influence of counter-measures (e.g. administration of chelating agents); d) investigation of the causes or implications of an exposure; e) dosimetry for inhalation exposures and for contaminated wounds.

ISO 16637:2016 specifies the minimum requirements for the design of professional programmes to monitor workers exposed to the risk of internal contamination via inhalation by the use of radionuclides as unsealed sources in nuclear medicine imaging and therapy departments. It establishes principles for the development of compatible goals and requirements for monitoring programmes and, when adequate, dose assessment. It presents procedures and assumptions for the risk analysis, for the monitoring programmes, and for the standardized interpretation of monitoring data. ISO 16637:2016 addresses the following items: a) purposes of monitoring and monitoring programmes; b) description of the different categories of monitoring programmes; c) quantitative criteria for conducting monitoring programmes; d) suitable methods for monitoring and criteria for their selection; e) information that has to be collected for the design of a monitoring programme; f) general requirements for monitoring programmes (e.g. detection limits, tolerated uncertainties); g) frequencies of measurements; h) procedures for dose assessment based on reference levels for routine and special monitoring programmes; i) assumptions for the selection of dose-critical parameter values; j) criteria for determining the significance of individual monitoring results; k) interpretation of workplace monitoring results; l) uncertainties arising from dose assessments and interpretation of bioassays data; m) reporting/documentation; n) quality assurance. ISO 16637:2016 does not address the following: - monitoring and internal dosimetry for the workers exposed to laboratory use of radionuclides such as radioimmunoassay techniques; - monitoring and internal dosimetry for the workers involved in the operation, maintenance, and servicing of PET cyclotrons; - detailed descriptions of measuring methods and techniques; - dosimetry for litigation cases; - modelling for the improvement of internal dosimetry; - the potential influence of medical treatment of the internal contamination; - the investigation of the causes or implications of an exposure; - dosimetry for ingestion exposures and for contaminated wounds.

ISO 16638-1:2015 specifies the minimum requirements for the design of professional programmes to monitor workers exposed to uranium compounds. It establishes principles for the development of compatible goals and requirements for monitoring programmes and dose assessment for workers occupationally exposed to internal contamination. It establishes procedures and assumptions for risk analysis, monitoring programmes and the standardised interpretation of monitoring data in order to achieve acceptable levels of reliability for uranium and its compounds. It sets limits for the applicability of the procedures in respect to dose levels above which more sophisticated methods have to be applied. Uranium is both radiologically and chemically toxic. Hence, the scientific bases of current occupational exposure standards are reviewed in addition to radiation exposure limits. This International Standard addresses those circumstances when exposure could be constrained by either radiological or chemical toxicity concerns. ISO 16638-1:2015 addresses, for uranium and its compounds, the following items: a) purposes of monitoring and monitoring programmes; b) description of the different categories of monitoring programmes; c) quantitative criteria for conducting monitoring programmes; d) suitable methods for monitoring and criteria for their selection; e) information that has to be collected for the design of a monitoring programme; f) general requirements for monitoring programmes (e.g. detection limits, tolerated uncertainties); g) frequencies of measurements; h) procedures for dose assessment based on reference levels for routine and special monitoring programmes; i) assumptions for the selection of dose-critical parameter values; j) criteria for determining the significance of monitoring results; k) interpretation of workplace monitoring results; l) uncertainties arising from dose assessment and interpretation of bioassays data; m) reporting/documentation; n) quality assurance; o) record keeping requirements. It is not applicable to the following items: a) monitoring of exposure due to uranium progeny, including radon; b) detailed descriptions of measuring methods and techniques for uranium; c) dosimetry for litigation cases; d) modelling for the improvement of internal dosimetry; e) potential influence of counter-measures (e.g. administration of chelating agents); f) investigation of the causes or implications of an exposure; g) dosimetry for ingestion exposures and for contaminated wounds.

ISO 27048:2011 specifies the minimum requirements for the evaluation of data from the monitoring of workers occupationally exposed to the risk of internal contamination by radioactive substances. It presents procedures and assumptions for the standardised interpretation of monitoring data, in order to achieve acceptable levels of reliability. Those procedures allow the quantification of exposures for the documentation of compliance with regulations and radiation protection programmes. Limits are set for the applicability of the procedures in respect of the dose levels above which more sophisticated methods will have to be applied. ISO 27048:2011 addresses the following: procedures for dose assessment based on reference levels for routine and special monitoring programmes; assumptions for the selection of dose-critical parameter values; criteria for determining the significance of monitoring results; interpretation of workplace monitoring results; uncertainties arising from sampling, measurement techniques and working conditions; the special topics of interpretation of multiple data arising from different measurement methods at different times, handling data below the decision threshold, rogue data, and calculation of doses to the embryo/foetus and infant; reporting/documentation; quality assurance. It is not applicable to the following: dosimetry for litigation cases; modelling for the improvement of internal dosimetry; the potential influence of decorporation measures (e.g. administration of chelating agents); the investigation of the causes or implications of an exposure; dosimetry for contaminated wounds.

This International Standard provides criteria for quality assurance and control, and evaluation of performance of radiobioassay service laboratories. Criteria and guidance for in vivo radiobioassay and in vitro radiobioassay are given in separate clauses. The following are within the scope of this International Standard: the accuracy of in vivo measurements of activity and quantities of selected important radionuclides in test phantoms, and in vitro measurements of activity and quantities of selected important radionuclides in test samples; minimal requirements for detection limit; minimum testing levels and testing ranges; requirements for reporting radiobioassay results by service laboratories; quality assurance in service laboratories; quality control in service laboratories; protocol for reporting test evaluations by service laboratories to the testing laboratory; default procedures when the service laboratory customer does not specify the performance criteria; applications of y# for different methods (see Annexes A and B). The following are not within the scope of this International Standard: detailed radiochemical methods for separating radionuclides from biological samples; detailed procedures for in vivo and in vitro radioactivity measurements; biokinetic data and mathematical models for converting radiobioassay results into dose (dose assessment); procedures for the preparation and distribution of test samples and phantoms by the testing laboratories.

ISO 20553:2006 specifies the minimum requirements for the design of professional programmes to monitor workers exposed to the risk of internal contamination by radioactive substances and establishes principles for the development of compatible goals and requirements for monitoring programmes.