IEC 60601-2-20:2016
Appareils électromédicaux – Partie 2-20: Exigences particulières pour la sécurité de base et les performances essentielles des incubateurs de transport pour nouveau-nés (Edition 2.1 Consolidated Reprint)

Standard No.

IEC 60601-2-20:2016

Release Date

2016

Published By

IEC - International Electrotechnical Commission

Status

Be replaced

Replace By

IEC 60601-2-20:2009/AMD1:2016

Latest

IEC 60601-2-20:2020/AMD1:2023 CSV

Scope

Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT TRANSPORT INCUBATOR equipment@ as defined in 201.3.211 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. HAZARDS 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 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: ?C devices supplying heat via BLANKETS@ PADS or MATTRESSES in medical use; for information see IEC 80601-2-35 [1]1); ?C INFANT INCUBATORS which are not INFANT TRANSPORT INCUBATOR; for information see IEC 60601-2-19 [2]; ?C INFANT RADIANT WARMERS; for information@ see IEC 60601-2-21 [3]; ?C INFANT PHOTOTHERAPY; for information@ see IEC 60601-2-50 [4]. 1) Figures between square brackets refer to the Bibliography

IEC 60601-2-20:2016 history

• 0000 IEC 60601-2-20:2020/AMD1:2023 CSV
• 1970 IEC 60601-2-20:2023 Medical electrical equipment; part 2: particular requirements for safety of transport incubators
• 0000 IEC 60601-2-20:2020 RLV
• 2016 IEC 60601-2-20:2009/AMD1:2016 Amendment 1 - Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
• 2016 IEC 60601-2-20:2016 Appareils électromédicaux – Partie 2-20: Exigences particulières pour la sécurité de base et les performances essentielles des incubateurs de transport pour nouveau-nés (Edition 2.1 Consolidated Reprint)
• 2013 IEC 60601-2-20:2009/COR2:2013 Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
• 2012 IEC 60601-2-20:2009/COR1:2012 Corrigendum 1 - Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
• 2009 IEC 60601-2-20:2009 Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
• 1970 IEC 60601-2-20:1990/AMD1:1996 Amendment 1 - Medical electrical equipment. Part 2: Particular requirements for the safety of transport incubators
• 1990 IEC 60601-2-20:1990 Medical electrical equipment; part 2: particular requirements for safety of transport incubators