NEK EN 60601-2-54:2009

Standard
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Norsk tittel: Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
Engelsk tittel: Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
Varetype: Standard
Språk: Engelsk
Utgave: 2009-09 (2009-10-01)
Erstatter: NEK EN 60601-2-28:1993 Alert Tilbaketrukket
NEK EN 60601-2-32:1994 Alert Tilbaketrukket
NEK EN 60601-2-7:1998 Alert Tilbaketrukket
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NOK 2 970,00 (eks. mva)
NOK 3 712,50 (ink. mva)

Omfang: IEC 60601-2-54:2009 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems intended to be used for projection radiography and radioscopy. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of ME equipment for radiography and radioscopy. Requirements for additional provisions for ME equipment for interventional applications are covered by IEC 60601-2-43. IEC 60601-2-54:2009 has been developed for use with the third edition of IEC 60601-1 (2005) and its collateral standards. IEC 60601-2-54:2009 is about type testing of X-ray systems. For the type test of a given product only one particular standard applies. Thus, IEC 60601-2-28 cannot be used in the type test according to IEC 60601-2-54:2009. The system aspects of the X-ray source integrated into X-ray systems are covered by IEC 60601-2-54:2009. IEC 60601-2-32 and IEC 60601-2-7, which had been written for use with the second edition of IEC 60601-1 (1988), cannot be used with the third edition of IEC 60601-1 (2005) and IEC 60601-2-54.
Komité: NEK/NK62
Fastsatt: 2009-10-01
ICS: 11.040.50 - Radiografi og annet diagnoseutstyr
903.07 - Elektromedisinsk utstyr