BS EN 60601-1-3:2008+A11:2016 Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard. Radiation protection in diagnostic X-ray equipment

BS EN 60601-1-3:2008+A11:2016

Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard. Radiation protection in diagnostic X-ray equipment

Status : Current, Work in hand   Published : September 2008

Format
PDF

Format
HARDCOPY



What is this standard about? 

BS EN 60601-1-3 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. BS EN 60601-1-3 looks at protective measures to be taken in the design and construction of diagnostic X-ray equipment. It complements BS EN 60601-1.

Who is this standard for?

  • Manufacturers and users of diagnostic X-ray 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?

This collateral standard applies to X-ray equipment and to subassemblies of such equipment, where radiological images of a patient are used for diagnosis, planning or guidance of medical procedures. 

It outlines protective measures to be taken by manufacturers in the design and construction of this equipment. This aims to protect patients and operators by keeping irradiation as low as is reasonably possible without jeopardizing the benefit of the radiological procedure. 

What’s changed since the last update?

The standard has been systematically reviewed by experts to ensure its continued market relevance and takes into consideration technological developments. This edition:

  • Focuses on the general requirements for radiation protection
  • Excludes content specific to projection radiography and radioscopy
  • Takes into account the principles governing the use of radiation for medical purposes as stated in publication 60 of the ICRP (International Commission on Radiological Protection)
  • Includes requirements for the provision of relevant technical information in accompanying documents



Standard NumberBS EN 60601-1-3:2008+A11:2016
TitleMedical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard. Radiation protection in diagnostic X-ray equipment
StatusCurrent, Work in hand
Publication Date30 September 2008
Normative References(Required to achieve compliance to this standard)IEC 60522:1999, IEC 60336, IEC/TR 60788:2004, EN 60336:2005, IEC 60601-1:2005/A1:2012, IEC 60601-1:2005, EN 60601-1:2006/A12:2014, IEC 60788:2004, EN 60601-1:2006/A1:2013, EN 60601-1:2006, ISO 497, EN 60522:1999
Informative References(Provided for Information)IEC 60627:2001, ICRP 73:1996, ICRP 60:1990, EN 60601-2-29:1999, ISO 7004:2002, ICRP 85:2000, EN 60601-2-43:2000, ICRP 87:2000, IEC 60601-2-45:2001, ICRP 34:1982, ICRU 60:1998, IEC 60878, EN 60601-2-44:2001, EN 60601-2-32:1994, EN 60601-2-28:1993, IEC 60601-2-44:2001/A1:2002, EN 60601-2-7:1998, IEC 62220-1:2003, ICRP 93:2004, IEC 62220, EN 60601-2-45:2001, EN 60580:2000, EN 61262, EN 60627:2001, IEC 60601-2-44:2001, 93/42/EEC, IEC 60601-2-43:2000, ICRU 74:2005, IEC 61262, EN 62220, ICRU 51:1993, EN 62220-1:2003, ICRP 33:1982, IEC 60601-2-32:1994, IEC 60601-2-29:1999, IEC 60601-2-28:1993, IEC 60601-2-7:1998, IEC 60580:2000
International RelationshipsIEC 60601-1-3:2008,EN 60601-1-3:2008/A11:2016
Amended ByAmendment, December 2016; Corrigendum, June 2014
DescriptorsRadiation shields, Radiation protection, Voltage, Radiology apparatus (medical), Radiation hazards, Testing conditions, Clinical investigation instruments, Performance testing, Electronic equipment and components, X-ray apparatus, Instructions for use, Medical radiology, Medical radiography, Medical equipment, Safety measures, Electrical medical equipment, Marking, Electrical equipment, X-rays, Radiation measurement, Type testing
ICS11.040.50
13.280
Title in FrenchAppareils électromédicaux. Exigences générales pour la sécurité de base et les performances essentielles. Norme collatérale. Radioprotection dans les appareils à rayonnement X de diagnostic
Title in GermanMedizinische elektrische Geräte. Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale. Ergänzungsnorm. Strahlenschutz von diagnostischen Röntgengeräten
CommitteeCH/62/2
ISBN978 0 580 96708 5
PublisherBSI
FormatA4
DeliveryYes
Pages56
File Size2.66 MB
Price£254.00


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