Scope and object
This clause of the General Standard applies except as follows:
Scope
Replacement:
This Particular Standard applies to HIGH-VOLTAGE GENERATORS of medical diagnostic X-RAY GENERATORS and to their sub assemblies including the following:
- HIGH-VOLTAGE GENERATORS that are integrated with an X-RAY TUBE ASSEMBLY;
- HIGH-VOLTAGE GENERATORS of radiotherapy treatment simulators.
Where appropriate, requirements for X-RAY GENERATORS are given but only where these concern the functioning of the associated HIGH-VOLTAGE GENERATOR.
This Standard excludes
- CAPACITOR DISCHARGE HIGH-VOLTAGE GENERATORS (these are covered by IEC 60601-2-15),
- HIGH-VOLTAGE GENERATORS for mammography,
- HIGH-VOLTAGE GENERATORS for RECONSTRUCTIVE TOMOGRAPHY.
1.2 Object
Replacement:
The object of this standard is to establish particular requirements to ensure safety and to specify methods for demonstrating compliance with those requirements.
NOTE 1 - Requirements for reproducibility, linearity, constancy and accuracy are given because of their relationship to the quality and quantity of the IONIZING RADIATION produced, and are confined to those considered necessary for safety.
NOTE 2 - Both the levels for compliance and the tests prescribed to determine compliance reflect the fact that the safety of HIGH-VOLTAGE GENERATORS is not sensitive to small differences in levels of performance. The combinations of LOADING FACTORS specified for the tests are, therefore, limited in number but chosen from experience as being appropriate in most cases. It is considered important to standardize the choice of combinations of LOADING FACTORS so that comparison can be made between tests performed in different places on different occasions. However, combinations other than those specified could be of equal technical validity.
NOTE 3 - The safety philosophy on which this standard is based is described in the introduction to the General Standard and in IEC 60513.
NOTE 4 - Concerning RADIO-LOGICAL PROTECTION it has been assumed in the preparation of this standard that MANUFACTURERS and USERS do accept the general principles of the ICRP as stated in ICRP 60, 1990, paragraph 112, namely:
a) No practice involving exposure to radiation should be adopted unless it produces sufficient benefit to the exposed individuals or to society to offset the radiation detriment it causes. (The justification of a practice.)
b) In relation to any particular source within a practice, the magnitude of individual doses, the number of people exposed, and the likelihood of incurring exposures where these are not certain to be received should all be kept as low as reasonably achievable, economic and social factors being taken into account. This procedure should be constrained by restrictions on doses to individuals (dose constraints), or the risk to individuals in the case of potential exposure (risk constraints), so as to limit the inequity likely to result from inherent economic and social judgments. (The optimization of protection.)
c) The exposure of individuals resulting from the combination of all the relevant practices should be subject to dose limits, or to some control of risk in the case of potential exposures. These are aimed at ensuring that no individual is exposed to radiation risks that are judged to be unacceptable from these practices in any normal circumstances. Not all sources are susceptible of control by action at the source and it is necessary to specify the sources to be included as relevant before selecting a dose limit. (Individual dose and risk limits).
NOTE 5 - Most of the requirements on X-RAY EQUIPMENT and its sub assemblies for protection against IONIZING RADIATION are given in the Collateral Standard IEC 60601-1-3.
This Standard does, however, deal with some aspects of RADIO-LOGICAL PROTECTION, mainly those that depend upon the supply, control and indication of electrical energy from the HIGH-VOLTAGE GENERATOR.
NOTE 6 - It is recognized that many of the judgments necessary to follow the ICRP general principles have to be made by the USER and not by the MANUFACTURER of the EQUIPMENT.
