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  • BSI
    BS EN IEC 60601-2-21:2021 - TC Tracked Changes. Medical electrical equipment - Particular requirements for the basic safety and essential performance of infant radiant warmers
    Edition: 2021
    $545.49
    / user per year

Description of BS EN IEC 60601-2-21:2021 - TC 2021

IEC 60601-2-21:2020 is available as IEC 60601-2-21:2020 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.

IEC 60601-2-21:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT RADIANT WARMERS as defined in 201.3.204, also referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document, except in 7.2.13 and 8.4.1 of the general standard. IEC 60601-2-21:2020 specifies the safety requirements for INFANT RADIANT WARMERS, but alternate methods of compliance with a specific clause, by demonstrating equivalent safety, will not be judged as non-compliant, if the MANUFACTURER has demonstrated in his RISK MANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of an acceptable level when weighed against the benefit of treatment from the device. This particular standard does not apply to: - devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use; for information, see IEC 60601-2-35; - INFANT INCUBATORS; for information, see IEC 60601-2-19; - INFANT TRANSPORT INCUBATORS, for information, see IEC 60601-2-20; - INFANT PHOTOTHERAPY EQUIPMENT, for information, see IEC 60601-2-50. SKIN TEMPERATURE SENSORS which are applied to operate a BABY CONTROLLED RADIANT WARMER including the displayed value are not considered to be a CLINICAL THERMOMETER in the sense of the particular standard ISO 80601-2-56. IEC 60601-2-21:2020 cancels and replaces the second edition published in 2009 and Amendment 1:2016. This edition constitutes a technical revision. IEC 60601-2-21:2020 includes the following significant technical change with respect to the previous edition: alignment with IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012.

Standard NumberBS EN IEC 60601-2-21:2021 - TC
TitleTracked Changes. Medical electrical equipment - Particular requirements for the basic safety and essential performance of infant radiant warmers
StatusWithdrawn
Publication Date2021-11-23
DescriptorsInfrared radiation, Mechanical testing, Electrical equipment, Marking, Paediatrics, Instructions for use, Infants, Electrical insulation, Radiant heaters, Thermal testing, Baby equipment, Automatic control systems, Strength of materials, Incubators, Testing conditions, Electrical medical equipment, Hazards, Temperature, Hospital equipment, Performance testing, Accuracy, Electronic equipment and components, Electrical safety, Alarm systems, Equipment safety, Safety devices, Environmental testing, Sound intensity, Incubators (infant), Medical equipment, Safety measures
ICS11.040.10 Anaesthetic, respiratory and reanimation equipment
CommitteeCH/62/4
ISBN978 0 539 20146 8
PublisherBSI
Pages116

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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