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   Published : November 2010

Format
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
Publication Date30 November 2010
Normative References(Required to achieve compliance to this standard)IEC 60601-1:2005, IEC 60601-1:2005/A1:2012, EN 60601-1:2006, EN 60601-1:2006/A1:2013, EN 60601-1:2006/A1:2013/Corrigendum 1:2014, EN 60601-1:2006/A12:2014, IEC 60601-1-2:2014, EN 60601-1-2:2015, IEC 60601-1-6:2010, IEC 60601-1-6:2010/A1:2013, EN 60601-1-6:2010, EN 60601-1-6:2010/A1:2015, IEC 60601-1-8:2006, IEC 60601-1-8:2006/A1:2012, EN 60601-1-8:2007, EN 60601-1-8:2007/Corrigendum 1:2010, EN 60601-1-8:2007/A1:2015, NEMA MS 4:2010, NEMA MS 8:2008, IEC 62570:2014, EN 62570:2015
Informative References(Provided for Information)93/42/EEC, ISO 7010:2011, EN ISO 7010:2012, 2003/10/EC, EN 45502-2-1:2003, 2013/35/EU, IEC 62570:2014, IEEE C95.6:2002, IEC 60364-7-710, IEC 62464-1:2007, ASTM 2052-06:2006
International RelationshipsEN 60601-2-33:2010,IEC 60601-2-33:2010
Amended ByCorrigendum, March 2011. Amendment, April 2012. Amends and replaces BS EN 60601-2-33:2010 which remains current. Amendment, July 2015. Amends and replaces BS EN 60601-2-33:2010+A11:2011 which remains current. Amendment, November 2015. Amends and replaces BS EN 60601-2-33:2010+A1:2015 which remains current. Corrigendum, May 2016. Amendment, December 2016. Amends and replaces BS EN 60601-2-33:2010+A2:2015 which remains current.
Draft Superseded By08/30170500 DC12/30267985 DC14/30303965 DC
DescriptorsMedical equipment, Electrical medical equipment, Electrical equipment, Electronic equipment and components, Safety engineering, Electrical safety, Safety measures, Protected electrical equipment, Nuclear magnetic resonance spectrometry, Clinical investigation instruments, Magnetic fields, Magnetic measurement, Resonance, Diagnosis (medical), Radiation protection, Occupational safety
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£328.00


 Your basket
Your basket is empty

Multi-user access to over 3,500 medical device standards, regulations, expert commentaries and other documents


Tracked Changes

Understand the changes made to a standard with our new Tracked Changes version


Worldwide Standards
We can source any standard from anywhere in the world


BSOL

The faster, easier way to work with standards