Radiographic equipment

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JS IEC 60601-2-54:2012 Medical electrical equipment Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy

This Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ME EQUIPMENT and ME SYSTEMS intended to be used for projection RADIOGRAPHY and RADIOSCOPY. IEC 60601-2-43 applies to ME EQUIPMENT and ME SYSTEMS intended to be used for interventional applications and refers to applicable requirements in this particular standard. (Published Document (JS))

JS IEC 60601-2-57:2012 Medical electrical equipment Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use

This Standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of equipment incorporating one or more sources of OPTICAL RADIATION in the wavelength range 200 nm to 3 000 nm, with the exception of laser radiation, and intended to create non-visual photo-biological effects in humans or animals for therapeutic, diagnostic, monitoring, cosmetic/aesthetic or veterinary applications; (Published Document (JS))

JS IEC 60601-2-44:2012 Medical electrical equipment Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography

This Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of CT SCANNERS, hereafter also referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME 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 ME EQUIPMENT and to ME SYSTEMS, (Published Document (JS))

JS IEC 60601-2-45:2012 Medical electrical equipment Part 2-45: Particular requirements for basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices

This standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MAMMOGRAPHIC X-RAY EQUIPMENT and MAMMOGRAPHIC STEREOTACTIC DEVICES, hereafter also referred to as ME EQUIPMENT. (Published Document (JS))

JS IEC 60601-2-27:2012 Medical electrical equipment Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment

This particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROCARDIOGRAPHIC (ECG) MONITORING EQUIPMENT as defined in 201.3.63 and hereinafter also referred to as ME EQUIPMENT. This particular standard applies to ME EQUIPMENT used in a hospital environment as well as when used outside the hospital environment, (Published Document (JS))

JS IEC 60601-2-40:2012 Medical electrical equipment Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment

This Particular Standard applies to ELECTROMYOGRAPHS as defined in 2.1.101 and EVOKED RESPONSE EQUIPMENT as defined in 2.1.102, hereinafter referred to as EQUIPMENT. (Published Document (JS))

JS IEC 60601-2-43:2012 Medical electrical equipment Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures

This Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, hereafter referred to as INTERVENTIONAL X-RAY EQUIPMENT. (Published Document (JS))

JS IEC 60601-2-7:2012 Medical electrical equipment Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators

This Standard applies to HIGH-VOLTAGE GENERATORS of medical diagnostic X-RAY GENERATORS and to their subassemblies including the following: – HIGH-VOLTAGE GENERATORS that are integrated with an X-RAY TUBE ASSEMBLY; – HIGH-VOLTAGE GENERATORS of radiotherapy treatment simulators. (Published Document (JS))

JS IEC 60601-2-22:2012 Medical electrical equipment Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

This Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of laser equipment for either surgical, therapeutic, medical diagnostic, cosmetic, or veterinary applications, intended for its use on humans or animals, classified as a CLASS 3B or CLASS 4 LASER PRODUCT as defined by 3.22 and 3.23 in IEC 60825-1, hereafter referred to as LASER EQUIPMENT. (Published Document (JS))

JS IEC 60601-2-8:2012 Medical electrical equipment Part 2-8: Particular requirements for basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV

This standard applies to the basic safety and essential performance of therapeutic X-RAY EQUIPMENT with NOMINAL X-RAY TUBE VOLTAGES in the range 10 kV to 1 MV when connected to alternating current SUPPLY MAINS, hereafter referred to as ME EQUIPMENT. (Published Document (JS))

JS IEC 60601-2-18:2012 Medical electrical equipment Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ENDOSCOPIC EQUIPMENT together with its INTERCONNECTION CONDITIONS and INTERFACE CONDITIONS. (Published Document (JS))

JS IEC 60601-2-32:2012 Medical electrical equipment Part 2-32: Particular requirements for the safety of associated equipment of X-ray equipment

This Particular Standard applies to equipment and devices associated with X-RAY EQUIPMENT as used for supporting and relatively positioning the functional components including the PATIENT SUPPORT used for the application of the X-RADIATION. (Published Document (JS))

JS IEC 60601-1-3:2012 Medical electrical equipment Part 1-3: General requirements for basic safety and essential performance ـــ Collateral Standard: Radiation protection in diagnostic X-ray equipment

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS. This collateral standard applies to X-RAY EQUIPMENT and to subassemblies of such equipment, where RADIOLOGICAL IMAGES of a human PATIENT are used for diagnosis, planning or guidance (Published Document (JS))

JS 1187:1997 Measurement - Clinical electrical thermometers with maximum device

Specifies the metrological and technical requirements for clinical electrical thermometers with amaximum device. Such instruments are designed to measure human oranimal body temperature. (Published Document (JS))

JS 1186:1997 Measurement - clinical electrical thermometers for continuous measurement

Specifies the metrological and technical requirements for clinical thermometers for continuous measurement of human or animal body temperature (Published Document (JS))

JS 1188-2:1997 Measurement - Non-invasive sphygmomanometers - Part 2: Supplementary requirements for mechanical sphygmomanometers

Specifies performance, efficiency and mechanical and electrical safety requirement, including test methods, fornon-invasive mechanical sphygmomanometers and their accessories. (Published Document (JS))

JS 1188-1:1997 Measurement - Non-invasive sphygmomanometers - Part 1: General requirement

Specifies general requirements for non-invasive sphygmomanometers and their accessories. (Published Document (JS))

JS 859:1992 Laboratory glassware - Clinical thermometers (mercury-in-glass with maximum device)

Applies to clinical mercury glassthermometers equiped by maximum device used to measure the internaltemperature of human body (Published Document (JS))