BS EN 60601-1:2006+A11:2011 Medical electrical equipment. General requirements for basic safety and essential performance

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BS EN 60601-1:2006+A11:2011

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

Status : Current, Work in hand   Published : November 2006

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What is BS EN 60601-1:2006+A11:2012?

BS EN 60601-1:2006+A11:2012 applies to medical electrical equipment that comes into contact with patients. It also covers systems where this equipment is connected with other equipment such as a video camera or a computer.
This international standard focuses on the basic safety and essential performance of medical electrical equipment and medical electrical systems.
 
BS EN 60601-1:2006+A11:2012 encapsulates a large body of expertise on safety and performance from around the world, for the benefit of all:

• Manufacturers - who can satisfy many markets around the world with a single design
• Regulatory bodies and independent certification bodies who assess safety and performance
• The professional users, patients and disabled persons who depend on the equipment

BS EN 60601-1:2006+A11:2011 supersedes BS EN 60601-1:2006, which will be withdrawn on 1 October 2014.

What has been updated?

The Annex ZZ of BS EN 60601-1:2006 and several of the particular standards in the 60601 series, have been updated following a request from the European Commission to provide a more detailed link between the clauses of mandated harmonized standards and the essential requirements of New Approach Directives. 

The technical requirements remain unchanged.




Standard NumberBS EN 60601-1:2006+A11:2011
TitleMedical electrical equipment. General requirements for basic safety and essential performance
StatusCurrent, Work in hand
Publication Date30 November 2006
Cross ReferencesIEC 60065:2001, IEC 60068-2-2:1974, IEC 60068-2-2:1974/AMD 1:1993, IEC 60068-2-2:1974/AMD 2:1994, IEC 60079-0, IEC 60079-2, IEC 60079-5, IEC 60079-6, IEC 60083, IEC 60085, IEC 60086-4, IEC 60112, IEC 60127-1:2006, IEC 60227-1:1993, IEC 60227-1:1993/AMD 1:1995, IEC 60227-1:1993/AMD 2:1998, IEC 60245-1:2003, IEC 60252-1, IEC 60320-1, IEC 60335-1:2001, IEC 60364-4-41:2005, IEC 60384-14:2005, IEC 60417-DB, IEC 60445, IEC 60447, IEC 60529:1989, IEC 60529:1989/AMD 1:1999, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-1-8, IEC 60664-1:1992, IEC 60664-1:1992/AMD 1:2000, IEC 60664-1:1992/AMD 2:2002, IEC 60695-11-10, IEC 60730-1:1999, IEC 60730-1:1999/AMD 1:2003, IEC 60825-1:1993, IEC 60825-1:1993/AMD 1:1997, IEC 60825-1:1993/AMD 2:2001, IEC 60851-3:1996, IEC 60851-3:1996/AMD 1:1997, IEC 60851-3:1996/AMD 2:2003, IEC 60851-5:1996, IEC 60851-5:1996/AMD 1:1997, IEC 60851-5:1996/AMD 2:2004, IEC 60851-6:1996, IEC 60851-6:1996/AMD 1:1997, IEC/TR 60878:2003, IEC 60884-1, IEC 60950-1:2001, IEC 61058-1:2000, IEC 61058-1:2000/AMD 1:2001, IEC 61558-1:1997, IEC 61558-1:1997/AMD 1:1998, IEC 61558-2-1, IEC 61672-1, IEC 61672-2, IEC 61965, ISO 31, ISO 780, ISO 1000, ISO 1853, ISO 2878, ISO 2882, ISO 3746, ISO 3864-1:2002, ISO 5349-1, ISO 7000-DB:2004, ISO 7010:2003, ISO 9614-1, ISO 10993, ISO 11134, ISO 11135, ISO 11137, ISO 13852, ISO 14971:2000, ISO 15223, ISO 23529, EN 60065:2002, EN 60065:2002/Corrigendum:2006, EN 60068-2-2:1993, EN 60068-2-2:1993/A1:1993, EN 60068-2-2:1993/A2:1994, EN 60079-0:2006, EN 60079-2:2004, EN 60079-2:2004/Corrigendum:2006, EN 60085:2004, EN 60086-4:2000, EN 60112:2003, EN 60127-1:2006, EN 60252-1:2001, EN 60320-1:2001, EN 60335-1:2002, EN 60335-1:2002/A11:2004, EN 60335-1:2002/A12:2006, EN 60335-1:2002/Corrigendum:2006, CENELEC HD 60364-4-41:2006, EN 60384-14:2005, EN 60445:2000, EN 60447:2004, EN 60529:1991, EN 60529:1991/Corrigendum:1993, EN 60529:1991/A1:2000, EN 60601-1-2:2001, EN 60601-1-3:1994, EN 60601-1-6:2004, EN 60601-1-8:2004, EN 60601-1-8:2004/Corrigendum:2006, EN 60664-1:2003, EN 60695-11-10:1999, EN 60730-1:2000, EN 60730-1:2000/A12:2003, EN 60730-1:2000/A1:2004, EN 60730-1:2000/A13:2004, EN 60730-1:2000/A14:2005, EN 60825-1:1994, EN 60825-1:1994/Corrigendum:1995, EN 60825-1:1994/A1:2002, EN 60825-1:1994/A2:2001, EN 60825-1:1994/Corrigendum:2004, EN 60851-3:1996, EN 60851-3:1996/A1:1997, EN 60851-3:1996/A2:2003, EN 60851-5:1996, EN 60851-5:1996/A1:1997, EN 60851-5:1996/A2:2004, EN 60851-6:1996, EN 60851-6:1996/A1:1997, EN 60950-1:2001, EN 60950-1:2001/Corrigendum:2004, EN 60950-1:2001/A11:2004, EN 61058-1:2002, EN 61558-1:1997, EN 61558-1:1997/Corrigendum:2003, EN 61558-1:1997/A1:1998, EN 61558-1:1997/A11:2003, EN 61558-2-1:1997, EN 61672-1:2003, EN 61672-2:2003, EN 61965:2003, EN ISO 780:1999, EN ISO 3746:1995, IEC 60050-151:2001, IEC 60050-195:1998, IEC 60050-195:1998/AMD 1:2001, IEC 60050-441:2001, IEC 60050-826:2004, IEC 60073, EN 60073:2002, IEC 60086-1, EN 60086-1:2001, IEC 60127-6, EN 60127-6:1994, IEC 60309-1, EN 60309-1:1999, IEC 60317-43, EN 601317-43:1997, IEC 60364-7-710, IEC 60479-1:1994, IEC 60513:1994, IEC 60601-1-1:2000, EN 60601-1-1:2001, IEC 60601-1-4:1996, IEC 60601-1-4:1996/AMD 1:1999, EN 60601-1-4:1996, EN 60601-1-4:1996/A1:1999, IEC 60601-2-4, IEC 60601-2-49:2001, EN 60601-2-49:2001, IEC 60695-1-1, EN 60695-1-1:2000, IEC 60721, EN 60721, IEC 60788:2004, IEC 60990, EN 60990:1999, IEC 61000-4-11, EN 61000-4-11:2004, IEC 61010-1:2001, EN 61010-1:2001, IEC 61140:2001, EN 61140:2002, IEC 61258, IEC 62079:2001, EN 62079:2001, IEC 62304, EN 62304:2006, ISO 407, EN ISO 13407:2004, ISO 5805, ISO 8041, EN ISO 8041:2005, ISO 13485, EN ISO 13485:2003, ISO 14708-1, IEV-DB:2002, ISO/IEC Guide 51:1999, ASTM STP 1262, ASTM STP 1267, ASTM STP 1395, EN 563, ICRP Publication 60:1990, MIL-HDBK-217:1995, NFPA 53:1999, NFPA 99:2002, UL 1439:1998, UL 2601-1:1997, 89/391/EEC, 90/385/EEC, 93/42/EEC
ReplacesBS EN 60601-1-1:2001, BS EN 60601-1-4:1997, BS 5724-1.4:1997,IEC 60601-1-4:1996, BS EN 60601-1:1990, BS 5724-1:1989
International RelationshipsEN 60601-1:2006 Identical, IEC 60601-1:2005 Identical
Amended ByCorrigendum May 2011. Amendment February 2012. Amends and replaces BS EN 60601-1:2006.
Supersedes Draft04/30106146 DC
Related Drafts in Progress11/30193150 DC
DescriptorsMedical equipment, Electrical medical equipment, Safety measures, Electrical safety, Performance, Hazards, Protected electrical equipment, Radiation hazards, Fire risks, Type testing, Electrical testing, Environmental testing, Environment (working), Circuits, Classification systems, Marking, Symbols, Testing conditions, Instructions for use, Electrical insulation, Earthing, Leakage currents, Impact testing, Drop tests, Flexible conductors, Leakage paths, Clearance distances, Heating tests, Penetration tests, Electrical equipment, Electronic equipment and components, Risk assessment, Control systems
ICS11.040.01 (Medical equipment in general)
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 0 580 77313 6
PublisherBSI
FormatA4
DeliveryYES
Pages386
File Size5.888 MB
Price£ 344.00


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