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IEC 60601-2-50

Medical electrical equipment – Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment

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Organization: IEC
Publication Date: 1 September 2020
Status: active
Page Count: 66
ICS Code (Therapy equipment): 11.040.60
scope:

This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT PHOTOTHERAPY EQUIPMENT, as defined in 201.3.203, 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.

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 document does not apply to:

- devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use; for information, see IEC 60601-2-35 [1]2;

- INFANT INCUBATORS; for information, see IEC 60601-2-19 [2];

- INFANT TRANSPORT INCUBATORS; for information, see IEC 60601-2-20 [3];

- INFANT RADIANT WARMERS; for information, see IEC 60601-2-21 [4].

2 The figures between brackets refer to the Bibliography.

Document History

IEC 60601-2-50
September 1, 2020
Medical electrical equipment – Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT PHOTOTHERAPY EQUIPMENT, as defined in 201.3.203, also referred to as ME EQUIPMENT. If a clause or subclause is...
April 1, 2016
AMENDMENT 1 Medical electrical equipment – Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
A description is not available for this item.
April 1, 2016
Medical electrical equipment – Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
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...
August 1, 2010
Medical electrical equipment – Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment CORRIGENDUM 1
Addition: This Particular Standard specifies requirements applicable to INFANT PHOTOTHERAPY EQUIPMENT (as defined in 2.1.101) which by means of visible radiation serve to reduce bilirubin in the body...
March 1, 2009
Medical electrical equipment – Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
Addition: This Particular Standard specifies requirements applicable to INFANT PHOTOTHERAPY EQUIPMENT (as defined in 2.1.101) which by means of visible radiation serve to reduce bilirubin in the body...
July 1, 2000
Medical Electrical Equipment - Part 2-50: Particular Requirements for the Safety of Infant Phototherapy Equipment
A description is not available for this item.
July 1, 2000
Medical Electrical Equipment - Part 2-50: Particular Requirements for the Safety of Infant Phototherapy Equipment
Addition: This Particular Standard specifies requirements applicable to INFANT PHOTOTHERAPY EQUIPMENT (as defined in 2.1.101) which by means of visible radiation serve to reduce bilirubin in the body...

References

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