SIST HD 395.2.15 S1:1998
(Main)Medical electrical equipment -- Part 2: Particular requirements for the safety of capacitor discharge X-ray generators
Medical electrical equipment -- Part 2: Particular requirements for the safety of capacitor discharge X-ray generators
Establishes requirements applying to capacitor discharge X-ray generators for medical radiology in which electrical energy for loading of the X-ray tube is primarily stored at and switched in the high-voltage circuit. Its object is to ensure safety and to specify methods for demonstrating compliance with the safety requirements.
Medizinische elektrische Geräte -- Teil 2: Besondere Festlegungen für die Sicherheit von Kondensatorgeneratoren
Appareils électromédicaux -- Partie 2: Règles particulières de sécurité pour groupes radiogènes à décharge de condensateur
Etablit des prescriptions qui s'appliquent aux groupes radiogènes à décharge de condensateur pour la radiographie médicale dans lesquels l'énergie électrique est surtout emmagasinée dans un condensateur et commutée dans un circuit à haute tension. Son objet est d'assurer la sécurité et d'établir des méthodes pour la conformité avec les prescriptions de sécurité.
Medical electrical equipment - Part 2: Particular requirements for the safety of capacitor discharge X-ray generators (IEC 60601-2-15:1988)
General Information
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This document specifies the performance requirements of instruments as used in the NON -
INVASIVE MEASUREMENT of X- RAY TUBE VOLTAGE up to 150 kV and the relevant compliance tests.
This document also describes the method for CALIBRATION and gives guidance for estimating
the uncertainty in measurements performed under conditions different from those during
CALIBRATION .
Applications for such measurement are found in diagnostic RADIOLOGY including mammography,
COMPUTED TOMOGRAPHY (CT), dental radiology and RADIOSCOPY . This document is not
concerned with the safety aspect of such instruments. The requirements for electrical safety
applying to them are contained in IEC 61010-1.
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This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of both FIXED and MOBILE X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, hereafter referred to as INTERVENTIONAL X-RAY EQUIPMENT. Its scope excludes, in particular:
- equipment for RADIOTHERAPY;
- equipment for COMPUTED TOMOGRAPHY;
- ACCESSORIES intended to be introduced into the PATIENT;
- mammographic X-RAY EQUIPMENT;
- dental X-RAY EQUIPMENT.
NOTE 1 Examples of RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, for which the use of INTERVENTIONAL X-RAY EQUIPMENT complying with this standard is recommended, are given in Annex AA.
NOTE 2 Specific requirements for magnetic navigation devices, and for the use of INTERVENTIONAL X-RAY EQUIPMENT in an operating room environment were not considered in this particular standard; therefore no specific requirements have been developed for these devices or uses. In any case, such devices or uses remain under the general clause requirements.
NOTE 3 INTERVENTIONAL X-RAY EQUIPMENT, when used for cone-beam CT mode, is covered by this standard and not by IEC 60601-2-44 [2]2. No additional requirements for operation in cone-beam CT mode were identified for this standard (see also Note 4 in 203.6.4.5).
INTERVENTIONAL X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, which does not include a PATIENT SUPPORT as part of the system, is exempt from the PATIENT SUPPORT provisions of this standard.
If a clause or subclause is specifically intended to be applicable to INTERVENTIONAL X-RAY EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to INTERVENTIONAL X-RAY EQUIPMENT and to ME SYSTEMS, as relevant.
NOTE 4 See also 4.2 of the general standard.
The subclauses of this standard supersede IEC 60601-2-54 subclauses. IEC 60601-2-54 applies only with regards to the cited subclauses; non-cited subclauses of IEC 60601-2-54 do not apply.
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This International Standard is applicable to X-RAY SOURCE ASSEMBLIES and X-RAY TUBE ASSEMBLIES, for use in MEDICAL DIAGNOSTIC RADIOLOGY for techniques in which the X-RAY PATTERN will be received simultaneously in all points of the IMAGE RECEPTION AREA.
This standard specifies a method for the determination of the greatest geometrically symmetrical RADIATION FIELD at a specified distance from the FOCAL SPOT for which the percentage AIR KERMA RATE along the major axes of the RADIATION FIELD does not fall below a permitted value.
NOTE 1 AIR KERMA or AIR KERMA RATE are the only practical verifiable physical quantities for X-RAY SOURCES. X-RAY SOURCES must be tested independently from MEDICAL ELECTRICAL SYSTEMS. Conversion to the characteristics of the X-RAY IMAGE RECEPTOR used in a MEDICAL ELECTRICAL SYSTEM may be done in addition.
In case multiple FOCAL SPOTS are not super-imposed, each focal spot has its own REFERENCE AXIS. Then the maximum RADIATION FIELD may be given for each FOCAL SPOT separately
NOTE 2 The maximum symmetrical RADIATION FIELD may change from its initial value as the X-RAY TUBE ages through use.
NOTE 3 If, for certain MEDICAL ELECTRICAL SYSTEMs the scope of IEC 60806 does not fit, then the special RADIATION FIELD requirements could be incorporated in the MEDICAL ELECTRICAL SYSTEM particular standard. However, a statement on the RADIATION FIELD while referring IEC 60806 is then no longer possible.
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This part of IEC 61010 specifies safety requirements for electrical equipment and its
accessories within the categories a) through c), wherever it is intended to be used, whenever
that equipment incorporates one or more of the following characteristics:
– A REFRIGERATING SYSTEM that is acted on or impacted by an integral heating function such
that the combined heating and REFRIGERATING SYSTEM generates additional and/or more
severe HAZARDS than those for the two systems if treated separately.
– The materials being treated in the intended application introduce significant heat into the
REFRIGERATING SYSTEM, so that the REFRIGERATING SYSTEM in the application yields
additional and/or more severe HAZARDS than those for the REFRIGERATING SYSTEM if
operated at the maximum RATED ambient temperature alone.
– An irradiation function for the materials being treated presenting additional HAZARDS.
– A function to expose the materials being treated to excessive humidity, carbon dioxide,
salt mist, or other substances which can result in additional HAZARDS.
– A function of MECHANICAL MOVEMENT presenting additional HAZARDS.
– Provision for an OPERATOR to walk in to the operating area to load or unload the materials
being treated.
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This part of IEC 61223 applies to DENTAL CONE-BEAM COMPUTED TOMOGRAPHY X-RAY EQUIPMENT,
hereafter also called DENTAL CBCT EQUIPMENT, that conforms to IEC 60601-2-63:2012+AMD1:2017+AMD2:2021.
NOTE 1 DENTAL CBCT EQUIPMENT is a subset of DENTAL EXTRA-ORAL X-RAY EQUIPMENT.
NOTE 2 DENTAL EXTRA-ORAL X-RAY EQUIPMENT can provide one or more of PANORAMIC, CEPHALOMETRIC, tomosynthesis and DENTAL CBCT imaging modalities, all of which are in the scope of the IEC 60601-2-63 basic safety and performance standard.
This document applies to ACCEPTANCE TESTS and CONSTANCY TESTS on DENTAL CONE-BEAM COMPUTED TOMOGRAPHY X-RAY EQUIPMENT.
The aim of ACCEPTANCE TESTS is to verify compliance of the installation or MAJOR SERVICE ACTION with specifications affecting the image quality, RADIATION OUTPUT and PATIENT positioning. The requirements specified in this document are minimal requirements. The MANUFACTURER can establish criteria for the tests described here that exceed the levels contained in this document. CONSTANCY TESTS are performed to ensure that the functional performance of ME EQUIPMENTmeets established criteria and to enable the early recognition of changes in the properties of components of the ME EQUIPMENT, and to verify compliance with specifications affecting the image quality, RADIATION OUTPUT and PATIENT positioning.
This document also contains requirements for the ACCOMPANYING DOCUMENTS associated with ACCEPTANCE AND CONSTANCY TESTING of the DENTAL CBCT EQUIPMENT.
This document does not apply to:
– aspects of thermal, EMD (electromagnetic disturbances), mechanical and electrical safety;
– aspects of mechanical, electrical and software performance, unless they are essential for performing the ACCEPTANCE TESTS and CONSTANCY TESTS, and directly affect image quality, RADIATION OUTPUT and PATIENT positioning.
NOTE 3 Such aspects are generally addressed by IEC 60601-1 (all parts).
Equipment in the scope of IEC 61223-3-5 is excluded from the scope of this document.
DENTAL EXTRA-ORAL X-RAY EQUIPMENT can provide modalities which are in the scope of IEC 61223-3-4. In this case, the respective clauses of the IEC 61223-3-4 apply.
The object of this document is to establish:
– the essential parameters which describe the performance of DENTAL CBCT EQUIPMENT with regard to the image quality, RADIATION OUTPUT and PATIENT positioning;
– methods of testing and whether measured quantities related to those parameters comply with the specified requirements.
These methods rely on non-invasive measurements performed once the installation or a MAJOR SERVICE ACTION is completed.
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