BS EN 60601-2-19:2009+A1:2016 Medical electrical equipment. Particular requirements for the basic safety and essential performance of infant incubators

BS EN 60601-2-19:2009+A1:2016

Medical electrical equipment. Particular requirements for the basic safety and essential performance of infant incubators

Status : Current, Work in hand   Published : July 2009

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HARDCOPY



What is this standard about? 

BS EN 60601-2-19 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 60601-2-19 covers the safety of infant incubator equipment. It complements BS EN 60601-1.

Who is this standard for?

  • Manufacturers, suppliers and users of infant incubator equipment and components
  • All healthcare facilities/hospitals/intensive care units• Health and safety professionals
  • Regulatory bodies and technical committees 

Why should you use this standard?

This collateral standard ensures that infant incubators are manufactured and operated in a way that prevents accidents and ensures the optimum safety of children. It specifies performance requirements and basic safety for areas such as temperature and oxygen control, warnings and safety notices, sound levels, audible alarms and air velocity.

It also specifies tests by which compliance with requirements can be verified. 

What’s changed since the last update?

BS EN 60601-2-19 has been systematically reviewed by experts, who have taken into consideration technological developments and changes to clinical practice. 

  • The normal load for an infant is reduced to 10kg
  • The temperature of the surfaces in contact with a patient shall not exceed 40⁰ C
  • Skin temperature sensors on baby controlled operators, which include a displayed value, are not considered as a clinical thermometer
  • Amendments have been made to conditions surrounding ambient temperature, humidity and atmospheric pressure
  • Additional warning and safety notices relating to use plus extra operating instructions
  • Manufacturers shall specify on accompanying documents the maximum CO2 concentration (subclause 201.12.4.2.101)



Standard NumberBS EN 60601-2-19:2009+A1:2016
TitleMedical electrical equipment. Particular requirements for the basic safety and essential performance of infant incubators
StatusCurrent, Work in hand
Publication Date31 July 2009
Normative References(Required to achieve compliance to this standard)IEC 60601-1-2, EN 60601-1-2:2015
Informative References(Provided for Information)ISO 80601-2-56, 93/42/EEC, IEC 60601-2-20, IEC 61672-1, EN 61672-1:2003, IEC 80601-2-35, IEC 60601-2-21, IEC 60601-2-50, EN 60601-2-21:2009, EN 60601-2-50:2009, EN ISO 80601-2-56
International RelationshipsIEC 60601-2-19:2009/AMD1:2016,IEC 60601-2-19:2009,EN 61169-42:2013,EN 60601-2-19 Amd 1 (12/16) IE
Amended ByAmendment, February 2017; Amendment, March 2012
Draft Superseded By15/30323100 DC
DescriptorsPerformance testing, Electrical equipment, Electronic equipment and components, Electromagnetic compatibility, Safety measures, Safety devices, Classification systems, Environmental testing, Electrical testing, Medical equipment, Identification methods, Fire safety, Electrical safety, Hospital equipment, Alarm systems, Fire risks, Restraint systems (protective), Sound intensity, Protected electrical equipment, Temperature, Testing conditions, Instructions for use, Control devices, Electrical medical equipment, Mechanical testing, Marking, Temperature controllers, Accuracy, Incubators (infant), Stability, Hazards, Strength of materials
ICS11.040.10
Title in FrenchAppareils électromédicaux. Exigences particulières pour la sécurité de base et les performances essentielles des incubateurs pour nouveau-nés
Title in GermanMedizinische elektrische Geräte. Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Säuglingsinkubatoren
CommitteeCH/62/4
ISBN978 0 580 90079 2
PublisherBSI
FormatA4
DeliveryYes
Pages44
File Size2.359 MB
Price£214.00


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