PD IEC/TR 62354:2014 - General testing procedures for medical electrical equipment

PD IEC/TR 62354:2014

General testing procedures for medical electrical equipment

Status : Current   Published : October 2014



IEC TR 62354:2014 applies to medical electrical equipment. The object of this technical report is to provide guidance on general testing procedures according to IEC 60601-1:1988 (including the collateral provisions of IEC 60601-1-1:2000) and IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012. This third edition cancels and replaces the second edition published in 2009. This edition constitutes a technical revision intended to align the guidance in this technical report with Amendment 1 to IEC 60601:2005. Several tests have been updated and additional test procedures added.

This technical report is to be read in conjunction with

IEC 60601-1:1988


IEC 60601-1-1:2000


IEC 60601-1:2005


Standard NumberPD IEC/TR 62354:2014
TitleGeneral testing procedures for medical electrical equipment
Publication Date31 October 2014
Normative References(Required to achieve compliance to this standard)IEC 60601-1:1998/AMD1:1991, ISO 80000-1, IEC 60529:1989/AMD1:1991, ISO 11137-1, IEC 61010, IEC 60601-1:2005, IEC 60601-1:1998/AMD2:1995, IEC 62133, IEC 61010-1, IEC 61672-2, IEC 60601-1-2, IEC 60252-1, IEC 61672-1, ISO/IEC 17025, IEC 60417, ISO 14971:2007, IEC 60529:1989, IEC 60364-4-41, IEC 60086-4, IEC 60127-1, ISO 11135-1, IEC 60601-1:1988, ISO 17665-1, IEC 60601-1:2005/AMD1:2012, IEC/TR 60513
Informative References(Provided for Information)IEC 60320-1, ISO/IEC Guide 51, IEC 61557-4:2007, IEC 60384-14, IEC 60884-1, IEC 61010-031:2002, IEC TR 62296:2003, IEC 60065:2001/AMD2:2019, IEC 60065:2001, IEC 60950-1:2001, ASTM D149 – 97a(2013), IEC 61010-2-010:2003, ISO 13852:1996, ISO 1853, ISO 2878, ISO 471:1995, ISO 5725-1:1994, IEC 60065:2001/AMD1:2005, IEC 61032:1997
International RelationshipsIEC TR 62354:2014
DescriptorsControl systems, Leakage currents, Electrical testing, Protected electrical equipment, Penetration tests, Type testing, Environmental testing, Circuits, Safety measures, Hazards, Instructions for use, Radiation hazards, Medical equipment, Symbols, Clearance distances, Heating tests, Environment (working), Testing conditions, Leakage paths, Electronic equipment and components, Classification systems, Fire risks, Marking, Risk assessment, Impact testing, Electrical insulation, Electrical medical equipment, Performance, Earthing, Drop tests, Electrical equipment, Flexible conductors, Electrical safety
ISBN978 0 580 87366 9
File Size2.769 MB

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