BS EN 60601-1-2:2015 Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard. Electromagnetic disturbances. Requirements and tests

BS EN 60601-1-2:2015

Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard. Electromagnetic disturbances. Requirements and tests

Status : Current, Work in hand   Published : October 2015



What is this standard about? 

BS EN 60601-1-2 is part of a series of international standards on medical electrical equipment, covering basic safety and essential performance for both equipment and systems.

It is a collateral standard – its objective is to specify requirements that are in addition to those of the general standard. This fourth edition of BS EN 60601-1-2 specifies immunity test levels for the safety of medical electrical equipment and systems. It covers equipment for use in professional healthcare facilities or the home, where different test levels may be appropriate. It complements BS EN 60601-1.

Who is this standard for?

  • Manufacturers and users of medical equipment 
  • Suppliers of medical electronic equipment and components
  • All healthcare facilities/hospitals/intensive care units
  • Health and safety professionals• Regulatory bodies 

Why should you use this standard?

With the spread of wireless and mobile technology, electromagnetic disturbances arise which can affect equipment and prevent it from working in the way it was intended to. So it is essential that medical equipment is not oversensitive to radio frequency interference. Likewise, electromagnetic emissions from a medical device shouldn’t interfere with other equipment and systems.

The updated standard recognizes that phones and other radio frequency devices can no longer be prohibited from most patient environments, as in many cases they have become essential to efficient healthcare provision – so specification of test levels assumes that portable radio frequency equipment may be used closer to the medical equipment than was recommended in the last edition. The standard specifies levels based on a reasonably foreseeable maximum level of electromagnetic disturbances.

What’s changed since the last update?

The standard has been systematically reviewed by experts to ensure its continued market relevance. It gives specific guidance on technological developments that include:

  • Adjusting test levels for special environments and under special circumstances
  • Incorporating electromagnetic disturbances into the risk management process
  • Identifying pass/fail criteria

Standard NumberBS EN 60601-1-2:2015
TitleMedical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard. Electromagnetic disturbances. Requirements and tests
StatusCurrent, Work in hand
Publication Date31 October 2015
Normative References(Required to achieve compliance to this standard)IEC 61000-4-2:2008, EN 60601-1-8:2007/Corrigendum 1:2010, IEC 61000-4-3:2006, EN 60601-1-8:2007, IEC 61000-4-11:2004, IEC 61000-4-4:2012, IEC 61000-4-5:2005, CISPR 16-1-2:2003, CISPR 16-1-2:2003/A1:2004, EN 61000-3-2:2006, IEC 61000-4-3:2006/A1:2007, EN 61000-4-3:2006+A2:2010, EN 61000-4-3:2006/IS1:2009, IEC 60601-1-11:2010, EN ISO 14971:2012, IEC 61000-3-2:2005/A1:2008, IEC 61000-3-2:2005/A2:2009, EN 55014-1:2006/A2:2011, IEC 60601-1-12:2014, EN 61000-4-4:2012, EN 55014-1:2006/A1:2009, CISPR 11:2009, EN 55011:2009, EN 55016-1-2:2004/A1:2005, EN 61000-3-2:2006+A1:2009, EN 61000-4-3:2006, IEC 61000-3-2:2005, IEC 60601-2-3:2012, ISO 7137:1995, EN 61000-3-3:2013, IEC 61000-4-6:2013, CISPR 16-1-2:2003/A2:2006, EN 61000-3-2:2006+A2:2009, IEC 61000-4-3:2006/A2:2010, EN 61000-4-2:2009, IEC 60601-2-2:2010, IEC 61000-3-3:2013, IEC 61000-4-8:2009, IEC 60601-1-8:2006/A1:2013, IEC 60601-1-8:2006, EN 55014-1:2006, EN 55016-1-2:2004/A2:2006, EN 60601-1:2006/A1:2013, EN 55032:2012, IEC 60601-1:2005, EN 61000-4-8:2010, EN 61000-4-3:2006+A1:2008, EN 60601-1-11:2010, EN 550
Informative References(Provided for Information)ISO 14708-3:2008, EN 55024:2010, MIL-STD-461G:2010, EN ISO/IEC 17025:2005, EN 61000-3-12:2011, CISPR 25:2008, IEC/TS 61000-1-2:2001, IEC 60601-6-1:2005, IEC/TS 61000-1-2:2008, IEC 61000-3-11:2000, CISPR 16-1-1:2010, IEC 61000-4-13:2002/A1:2009, IEC 60601-2-27:2011, EN 60601-1-2:2007, RTCA DO-160G:2010, IEC/TR 61000-1-1:1992, AAMI TIR 18:2010, ISO 11452-9:2010, EN 60601-6-2:2005, EN 60601-6-1:2007, ISO 17025:2005, ANSI C63.7:2005, IEC 60601-6-2:2005, ISO 11452-8:2007, EN 60601-2-27:2006, CISPR 16-2-3:2010, 93/42/EEC, IEC 61496-1:2008, CISPR 16-1-1:2010/A1:2010, ANSI C63.14:2009, IEC 60601-2-44:2009, EN 55103-2:2009, IEC 61000-4-13:2002, CISPR 16-2-3:2010/A1:2010, EN 60601-2-44:2009, EN 55025:2008, IEC 60601-1-2:2007, EN 61496-1:2008, IEC 61000-6-2:2005, IEC 60050-161:1990, ANSI C63.4:2009, EUROCAE ED-14G:2011, IEC 61000-6-1:2005, IEC/TR 61000-2-5, ISO 11451-3:2007, EN 55016-2-3:2010, EN 61000-3-11:2000, ISO/TR 16142:2006, EN 55016-1-1:2010, IEC 61000-3-12:2011, CISPR 24:2010, IEC/TR 60788:2004
ReplacesBS EN 60601-1-2:2007
International RelationshipsEN 60601-1-2:2015,IEC 60601-1-2:2014
Draft Superseded By12/30159217 DC
DescriptorsMedical equipment, Radio disturbances, Electromagnetic radiation, Safety measures, Electronic equipment and components, Electrical medical equipment, Performance testing, Electrical equipment, Noise (spurious signals), Electrical safety, Performance, Electromagnetic compatibility
Title in FrenchAppareils électromédicaux. Exigences générales pour la sécurité de base et les performances essentielles. Norme collatérale: Perturbations électromagnétiques. Exigences et essais
Title in GermanMedizinische elektrische Geräte. Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale. Ergänzungsnorm: Elektromagnetische Störgrößen. Anforderungen und Prüfungen
ISBN978 0 580 58060 4
File Size2.241 MB

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