BS EN 60601-1:2006 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.

BS EN 60601-1:2006 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 series F F2F). BS EN 60601-1:2006 does not apply to the implantable parts of active implantable medical devices covered by ISO 14708-1 F F3F).



Cross References:
IEC 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
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
IEC 60384-14:2005
IEC 60417-DB:2002
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 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
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
EN 60065:2002
EN 60065:2002/Corr: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/Corr: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/Corr:2006
HD 60364-4-41:2006
EN 60384-14:2005
EN 60445:2000
EN 60447:2004
EN 60529:1991
EN 60529:1991/Corr: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/Corr: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/Corr:1995
EN 60825-1:1994/A1:2002
EN 60825-1:1994/A2:2001
EN 60825-1:1994/Corr: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/Corr:2004
EN 60950-1:2001/A11:2004
EN 61058-1:2002
EN 6

Replaces BS EN 60601-1:1990, BS EN 60601-1-1:2001 and BS EN 60601-1-4:1997 which remain current.