BS EN 80601-2-35:2009+A1:2016 Medical electrical equipment. Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use

BS EN 80601-2-35:2009+A1:2016

Medical electrical equipment. Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use

Status : Current, Under review   Published : March 2010

Format
PDF

Format
HARDCOPY



What is this standard about? 

BS EN 80601 is a series of technical standards covering medical electrical equipment. Part-2-35 is the latest revision to the standard that covers the safety and performance requirements for heating devices using blankets, pads or mattresses.

Who is this standard for?

  • Manufacturers, suppliers and operators of heating devices
  • All healthcare facilities/hospitals
  • Health and safety professionals
  • Healthcare regulatory bodies

Why should you use this standard? 

The guidelines specified in this part of BS EN 80601 aim to minimize the dangers to patients and medical operators that might arise from using these type of heating devices.The standard also specifies tests for demonstrating compliance with these requirements. 

Heating devices intended to pre-warm a bed are also included in the scope of this European standard. 

What’s changed since the last update?

This edition constitutes a technical revision. It provides consistency with the third edition of BS EN 60601-1, as well as with other standards related to paediatric equipment and includes the following changes:

  • Amendment specifying heating devices shall have type BF applied parts or type CF applied parts
  • Additional minimum requirements for marking
  • Additional requirements for warning and safety notices and start-up procedures
  • Additional requirements for means of patient protection (MOPP)



Standard NumberBS EN 80601-2-35:2009+A1:2016
TitleMedical electrical equipment. Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
StatusCurrent, Under review
Publication Date31 March 2010
Normative References(Required to achieve compliance to this standard)EN ISO 2439:2008, EN 60601-1-10:2008+A1:2015, EN 60601-1-8:2017+A1:2013/Corrigendum 1:2014, EN ISO 14971:2007, ISO 2439:2008, EN 60601-1-2:2015, IEC 60601-1-10, IEC 60601-1-8, EN 60601-1-8:2017/Corrigendum 1:2010, ISO 14971:2007, EN 60601-1-10:2008, IEC 60601-1-2, EN 60601-1-8:2017, EN 60601-1-8:2017+A1:2013
Informative References(Provided for Information)ASTM F1690-96:2004, EN 60601-2-20:2009, IEC 60601-2-19, IEC 60601-2-20, 93/42/EEC, ASTM C578-01, EN 60601-2-19:2009, EN 60601-2-21:2009, IEC 60335-2-53, IEC 60601-2-21, EN 60335-2-53:2003
International RelationshipsIEC 80601-2-35:2009/AMD1:2016,IEC 80601-2-35:2009,EN 80601-2-35 Amd 1 (12/16) IE,EN 61300-2-23:2011
Amended ByAmendment, January 2017; Amendment, March 2012
Draft Superseded By15/30323081 DC
DescriptorsPerformance, Safety measures, Electrical equipment, Electric pads, Medical equipment, Electrical faults, Equipment safety, Hospital equipment, Electric blankets, Mechanical testing, Performance testing, Alarm systems, Instructions for use, Test equipment, Temperature, Testing conditions, Folding, Mattresses, Heaters, Thermal resistance, Impact testing, Marking, Electrical safety, Electromagnetic compatibility, Electronic equipment and components, Sound intensity, Bend testing, Electrical medical equipment, Electric heaters, Blankets, Fire tests, Accuracy
ICS11.040.01
Title in FrenchAppareils électromédicaux. Exigences particulières pour la sécurité de base et les performances essentielles des dispositifs de réchauffage utilisant des couvertures, des coussins ou des matelas chauffants et destinés au réchauffage des patients en usage médical
Title in GermanMedizinische elektrische Geräte. Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Decken, Matten und Matratzen zur Erwärmung von Patienten in der medizinischen Anwendung
CommitteeCH/62/4
ISBN978 0 580 90076 1
PublisherBSI
FormatA4
DeliveryYes
Pages76
File Size2.68 MB
Price£274.00


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