BS EN 45502-1:2015 specifies requirements that are generally applicable to ACTIVE IMPLANTABLE MEDICAL DEVICES.

NOTE 1 For particular types of ACTIVE IMPLANTABLE MEDICAL DEVICES, these general requirements are supplemented or modified by the requirements of particular standards which form additional parts of this European Standard.

The tests that are specified in EN 45502 are type tests and are to be carried out on samples of an ACTIVE IMPLANTABLE MEDICAL DEVICE to show compliance.

This part of EN 45502 is applicable not only to ACTIVE IMPLANTABLE MEDICAL DEVICES that are electrically powered but also to those powered by other energy sources (for example by gas pressure or by springs).

This part of EN 45502 is also applicable to some non-implantable parts and accessories of the ACTIVE IMPLANTABLE MEDICAL DEVICES.


Cross References:
EN 60068-2-14:2009
IEC 60068-2-14:2009
EN 60068-2-27:2009
IEC 60068-2-27:2008
EN 60068-2-47:2005
IEC 60068-2-47:2005
EN 60068-2-64:2008
IEC 60068-2-64:2008
EN 60601-1:2006
IEC 60601-1:2005
EN 60601-1:2006/A1:2013
IEC 60601-1:2005/A1:2012
EN 62304:2006
IEC 62304:2006
EN 62366:2008
IEC 62366:2007
EN ISO 10993-1:2009
ISO 10993-1:2003
EN ISO 11607-1:2006
ISO 11607-1:2006
EN ISO 14155:2011-10
ISO 14155:2011
EN ISO 14971:2012
ISO 14971:2007
ISO 8601:2004
EN 50061:1988
EN 60068-2-64:1994
IEC 60068-2-64:1993
ISO 7000
EN ISO 10993-9:2009
ISO 10993-9:2009
EN ISO 11135-1
ISO 11135-1
EN ISO 11137-1
ISO 11137-1
EN ISO 11137-2
ISO 11137-2
EN ISO 13485
ISO 13485
ISO/TR 14283:2004
EN ISO 14937
ISO 14937
EN ISO 15223-1:2012
ISO 15223-1:2012
EN ISO 17665-1
ISO 17665-1
ISO/TS 10974
AAMI TIR42:2010
90/385/EEC
96/29/EU
1999/519/EC
2001/83/EC
FIPS PUB 199
EN 62127-1:2007
IEC 62127-1:2007


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