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  • DS/EN IEC 60601-2-20:2020

DS/EN IEC 60601-2-20:2020

Medical electrical equipment – Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators


Status:
Current
Type:
Standard
Language:
English
Price from:
€ 96.69
Legislation:

Scope

This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT
TRANSPORT INCUBATOR equipment, as defined in 201.3.208, 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 TRANSPORT INCUBATORS, 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 [1]2;
– INFANT INCUBATORS which are not INFANT TRANSPORT INCUBATOR; for information see
IEC 60601-2-19 [2];
– INFANT RADIANT WARMERS; for information, see IEC 60601-2-21 [3];
– INFANT PHOTOTHERAPY; for information, see IEC 60601-2-50 [4].

Number of pages: 54

Published: 2020-10-12

Date of approval: 2020-10-12

International relationships : EN IEC 60601-2-20:2020 IDT IEC 60601-2-20:2020 ED3 IDT

ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment

Item number: M330239


Committees

Committee

  • CLC/TC 62
  • IEC/TC 62/SC 62D

Danish committee

DS/S-562