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  • BSI
    BS EN 60601-2-50:2009+A1:2016 Medical electrical equipment - Particular requirements for the basic safety and essential performance of infant phototherapy equipment
    Edition: 2017
    $442.60
    / user per year

Description of BS EN 60601-2-50:2009+A1:2016 2017

Replacement:

This International Standard applies to the basic safety and essential performance of infant phototherapy equipment, as defined in 201.3.203 of this standard, 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.

H azards inherent in the intended physiological function of me equipment or me systems within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.

NOTE

See also 4.2 of the general standard.

This particular standard specifies safety requirements for infant phototherapy equipment, 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 80601‑2‑35 ;

  • infant incubators; for information see IEC 60601‑2‑19 ;

  • infant transport incubators; for information, see IEC 60601‑2‑20 ;

  • infant radiant warmers; for information see IEC 60601‑2‑21 .



Standard NumberBS EN 60601-2-50:2009+A1:2016
TitleMedical electrical equipment - Particular requirements for the basic safety and essential performance of infant phototherapy equipment
StatusWithdrawn
Publication Date2017-01-31
Withdrawn Date2021-08-13
ReplacesBS EN 60601-2-50:2009+A11:2011, BS EN 60601-2-50:2002
Identical National Standard OfIEC 60601-2-50:2009/AMD1:2016, IEC 60601-2-50:2009, EN 60601-2-50 Amd 1 (12/16) IEC AS
AmendsBS EN 60601-2-50:2009+A11:2011, BS EN 60601-2-50:2009, 15/30323076 DC
DescriptorsInfants, Therapeutics, Phototherapy, Safety measures, Electrical equipment, Electrical medical equipment, Electrical safety, Medical equipment, Medical radiology, Electronic equipment and components
ICS11.040.60 Therapy equipment
CommitteeCH/62/4
ISBN978 0 580 90075 4
PublisherBSI
Pages36

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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