BS EN 60601-2-33:2010+A12:2016 Medical electrical equipment. Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis

BS EN 60601-2-33:2010+A12:2016

Medical electrical equipment. Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis

Status : Current, Work in hand   Published : November 2010

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PDF

Format
HARDCOPY



What is this standard about? 

BS EN 60601-2-33 is part of a series of international standards on medical electrical equipment, covering basic safety and essential performance for both equipment and systems. This latest update to Part 2-33 outlines guidelines relating specifically to Magnetic Resonance (MR) equipment. It complements BS EN 60601-1.

Who is this standard for?

  • Manufacturers, suppliers and operators of magnetic resonance equipment 
  • All MRI departments/healthcare facilities/hospitals/intensive care units
  • Health and safety professionals• Regulatory bodies 

Why should you use this standard? 

Development in the field of MR continues and its use as a diagnostic tool in the medical profession is increasingly popular. This updated standard outlining safety and performance of this specialist equipment aims to improve patient safety and provide protection for the MR operative. 

NOTE: The standard assumes MR workers are medically screened and properly trained.

What’s changed since the last update?

  • The standard has been systematically reviewed by experts to ensure its continued market relevance and adherence to clinical best practice
  • Amendments to further protect against hazardous output and excessive acoustic noise
  • Improved safety provision such as in the design and manufacture to prevent accidental Helium loss in the event of a quench
  • Updated health and safety provisions, relating to fire risk, environmental conditions such as magnetic fields and electrostatic discharge



Standard NumberBS EN 60601-2-33:2010+A12:2016
TitleMedical electrical equipment. Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
StatusCurrent, Work in hand
Publication Date30 November 2010
Normative References(Required to achieve compliance to this standard)EN 60601-1:2006/A1:2013/Corrigendum 1:2014, IEC 60601-1:2005, EN 60601-1:2006/A12:2014, IEC 60601-1-8:2006/A1:2012, EN 60601-1:2006, IEC 60601-1:2005/A1:2012, NEMA MS 8:2008, EN 60601-1-6:2010/A1:2015, EN 60601-1:2006/A1:2013, IEC 60601-1-6:2010/A1:2013, IEC 60601-1-2:2014, NEMA MS 4:2010, EN 60601-1-8:2007, EN 62570:2015, IEC 62570:2014, IEC 60601-1-6:2010, EN 60601-1-2:2015, EN 60601-1-8:2007/Corrigendum 1:2010, IEC 60601-1-8:2006, EN 60601-1-8:2007/A1:2015, EN 60601-1-6:2010
Informative References(Provided for Information)EN ISO 7010:2012, ISO 7010:2011, ASTM 2052-06:2006, EN 45502-2-1:2003, 2003/10/EC, IEC 60364-7-710, 93/42/EEC, IEC 62464-1:2007, IEEE C95.6:2002, IEC 62570:2014, 2013/35/EU
International RelationshipsEN 60601-2-33:2010/A12:2016,IEC 60601-2-33:2010
Amended ByAmendment, December 2016; Corrigendum, May 2016
DescriptorsResonance, Magnetic measurement, Diagnosis (medical), Protected electrical equipment, Medical equipment, Nuclear magnetic resonance spectrometry, Magnetic fields, Clinical investigation instruments, Electrical safety, Electrical medical equipment, Occupational safety, Safety engineering, Radiation protection, Safety measures, Electrical equipment, Electronic equipment and components
ICS11.040.55
Title in FrenchAppareils électromédicaux. Exigences particulières pour la sécurité de base et les performances essentielles des appareils à résonance magnétique utilisés pour le diagnostic médical
Title in GermanMedizinische elektrische Geräte. Besondere Festlegungen für die Sicherheit von Magnetresonanzgeräten für die medizinische Diagnostik
CommitteeCH/62/2
ISBN978 0 580 96709 2
PublisherBSI
FormatA4
DeliveryYes
Pages146
File Size16.89 MB
Price£336.00


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