BS EN 60601-1:2006+A12:2014 Medical electrical equipment. General requirements for basic safety and essential performance

BS EN 60601-1:2006+A12:2014

Medical electrical equipment. General requirements for basic safety and essential performance

Status : Current, Work in hand   Published : November 2006

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PDF

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HARDCOPY



What is this standard about?

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.

The IEC 60601 series does not apply to: 

  • in vitro diagnostic equipment that does not fall within the definition of ME Equipment, which is covered by the IEC 61010 series (61)
  • implatable parts of active implantable medical devices covered by the ISO 14708 series (69)
  • medical gas pipeline sustems covered by ISO 7396-1 (68)

The object of this standard is to specify general requirements and to serve as the basis for particular standards. 




Standard NumberBS EN 60601-1:2006+A12:2014
TitleMedical electrical equipment. General requirements for basic safety and essential performance
StatusCurrent, Work in hand
Publication Date30 November 2006
Normative References(Required to achieve compliance to this standard)IEC 60227-1:1993, IEC 60085, IEC 60447, EN 60529:1991, IEC 60851-6:1996, IEC 60112, IEC 60079-2, IEC 60335-1:2010, EN 60730-1:2011, EN 60320-1:2001, IEC 60825-1:2007, HD 21.1 S4:2002, IEC 60664-1:2007, IEC 60245-1:2003, EN 60447:2004, EN 61558-2-1:2007, EN 60065:2002, IEC 61558-2-1, EN 60825-1:2007, IEC 60445, IEC 60417:2004, EN 60127-1:2006, IEC 60851-5:2008, IEC 60601-1-3, EN 60695-11-10:1999, IEC 60079-0, IEC 60079-6, IEC 60950-1:2001, EN 60384-14:2005, IEC 60601-1-2, IEC 60695-11-10, EN 60079-0:2012, EN 60252-1:2011, IEC 60068-2-2:2007, IEC 60065:2001, EN 60086-4:2007, IEC 60127-1:2006, IEC 60364-4-41:2005, EN 60601-1-8:2007, IEC 60601-1-8, IEC 60384-14:2005, EN 60068-2-2:2007, EN 61058-1:2002, IEC 60252-1, TR 60878:2003, IEC 60601-1-6, EN 60079-6:2007, IEC 60320-1, EN 60112:2003, EN 60601-1-3:2008, EN 60079-5:2007, IEC 60529:1989, IEC 61058-1:2000, IEC 60851-3:2009, EN 60851-5:2008, IEC 60083:2009, EN 60664-1:2007, IEC 60079-5, EN 60851-3:2009, EN 60950-1:2001, EN 60079-2:2007, EN 60085:2008, IEC 60086-4, EN 60445:2010, IEC 60884-1:2013, EN 60601-1-2:2007, EN 60601-1-6
Informative References(Provided for Information)EN 61010, IEC 61558-2-4, EN 60601-1-11, UL 2556:2007, IEC 62079:2001, EN 61140:2002, IEC 60050-826:2004, EN 60601-1-1:2001, IEC 61558-2-23, IEC 60601-2-22, IEC 61140:2001, EN 60127-6:1994, EN ISO 407, EN ISO 8041:2005, IEC 60788:2004, ICRP Publication 60:1990, EN 60332-2-2, ISO 8041, EN 60601-1-4:1996+A1:1999, AAMI HE-75:2009, IEC 60695-1-10, ISO 15001, EN 563, IEC 60601-1-12, EN 60332-1-2, EN 60317-43:1997, TR 62354, EN 61558-2-23, ISO 7396-1, IEC 62353, EN 61000-4-11:2004, IEC Guide 51:1999, IEC 60086-1, EN 60695-1-10, ASTM STP 1395:2000, IEC 60601-1-1:2000, IEC 60332-1-2, EN ISO 7396-1, ASTM STP 1262:1996, UL 2601-1:1997, ISO 407, NFPA 99:2002, EN 62471:2008, ISO 13485, IEC 61010, ASTM STP 1267:1996, IEC 60721, IEC 60127-6, IEC 61558-1, EN 60601-2-22, EN 60601-2-49:2001, EN ISO 13407:2004, IEC 61000-4-11, IEC 60050-151:2001, IEC 60601-2-49:2001, IEC 60317-43, EN ISO 13485:2003, EN 62353, EN 60309-1:1999, EN 61558-1, EN 61010-1:2010, IEV-DB:2002, MIL-HDBK-217:1995, IEC 60332-2-2, EN 60086-1:2001, EN 60721, EN 61558-2-4, IEC 60990, IEC 60601-1-11, IEC 62471:2006, EN 60990:1999
ReplacesBS EN 60601-1-1:2001, BS EN 60601-1-4:1997, BS 5724-1.4:1997 IEC 60601-1-4, BS EN 60601-1:1990, BS 5724-1:1989
International RelationshipsEN 60601-1 Amd 12 (10/14),IEC 60601-1:2005/AMD1:2012/COR
Amended ByCorrigendum, June 2018; Corrigendum, July 2017
DescriptorsHeating tests, Protected electrical equipment, Symbols, Medical equipment, Electrical safety, Penetration tests, Earthing, Electrical medical equipment, Radiation hazards, Risk assessment, Circuits, Environment (working), Marking, Hazards, Type testing, Control systems, Electrical testing, Environmental testing, Clearance distances, Impact testing, Electronic equipment and components, Electrical insulation, Performance, Drop tests, Electrical equipment, Leakage currents, Instructions for use, Classification systems, Flexible conductors, Testing conditions, Safety measures, Leakage paths, Fire risks
ICS11.040.01
Title in FrenchAppareils électromédicaux Exigences générales pour la sécurité de base et les performances essentielles
Title in GermanMedizinische elektrische Geräte Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale
CommitteeCH/62/1
ISBN978 0 539 00575 2
PublisherBSI
FormatA4
DeliveryYes
Pages426
File Size23.56 MB
Price£446.00


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