IEC 60601-2-54:2010 PDF

Standard No.: IEC 60601-2-54:2010
Release Date: 2010
Published By: IEC - International Electrotechnical Commission
Status: Be replaced
Replace By: IEC 60601-2-54:2009/COR1:2010
Latest: IEC 60601-2-54:2022 RLV

Scope: 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. 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@ as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1. NOTE See also 4.2. This standard can also be applied to equipment used for compensation or alleviation of disease@ injury or disability. In vitro diagnostic equipment that does not fall within the definition of ME EQUIPMENT is covered by the IEC 61010 series2). This standard does not apply to the implantable parts of active implantable medical devices covered by ISO 14708-1 3).This Particular Standard specifies requirements for the safety of HIGH FREQUENCY SURGICAL EQUIPMENT and HF SURGICAL ACCESSORIES used in medical practice@ as defined in 2.1.110 and hereinafter referred to as HF SURGICAL EQUIPMENT. HF SURGICAL EQUIPMENT having a RATED OUTPUT POWER not exceeding 50 W (for example for micro-coagulation@ or for use in dentistry or ophthalmology) is exempt from certain of the requirements of this Particular Standard. These exemptions are indicated in the relevant requirements.2) IEC 61010 (all parts)@ Safety requirements for electrical equipment for measurement@ control@ and laboratory use 3) ISO 14708-1@ Implants for surgery ?C Active implantable medical devices ?C Part 1: General requirements for safety@ marking and for information to be provided by the manufacturer ObjectThe object of this Particular Standard is to establish particular requirements for the safety of HF SURGICAL EQUIPMENT.

IEC 60601-2-54:2010 history

0000 IEC 60601-2-54:2022 RLV
2018 IEC 60601-2-54:2009/AMD2:2018 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy; Amendment 2
2018 IEC 60601-2-54:2018 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
2015 IEC 60601-2-54:2009/AMD1:2015 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
2015 IEC 60601-2-54:2015 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
2011 IEC 60601-2-54:2009/COR2:2011 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
2010 IEC 60601-2-54:2009/COR1:2010 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
2010 IEC 60601-2-54:2010 Medical electrical equipment – Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy CORRIGENDUM 1 (Edition 1.0; Includes Corrigendum's: 03/2010 and 06/2011)
2009 IEC 60601-2-54:2009 IEC 60601-2-54, Ed. 1: Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy

IEC 60601-2-54:2010Medical electrical equipment – Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy CORRIGENDUM 1 (Edition 1.0; Includes Corrigendum's: 03/2010 and 06/2011)

IEC 60601-2-54:2010 history

IEC 60601-2-54:2010
Medical electrical equipment – Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy CORRIGENDUM 1 (Edition 1.0; Includes Corrigendum's: 03/2010 and 06/2011)