BS EN IEC 60601-2-20:2020 - Medical electrical equipment. Particular requirements for the basic safety and essential performance of infant transport incubators

BS EN IEC 60601-2-20:2020

Medical electrical equipment. Particular requirements for the basic safety and essential performance of infant transport incubators

Status : Current   Published : October 2020



IEC 60601-2-20:2020 is available as

IEC 60601-2-20:2020 RLV

which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.

IEC 60601-2-20:2020 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. IEC 60601-2-20:2020 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;

- INFANT INCUBATORS which are not INFANT TRANSPORT INCUBATOR; for information see IEC 60601-2-19;

- INFANT RADIANT WARMERS; for information, see IEC 60601-2-21;

- INFANT PHOTOTHERAPY; for information, see IEC 60601-2-50.

IEC 60601-2-20:2020 cancels and replaces the second edition published in 2009 and Amendment 1:2016. This edition constitutes a technical revision.

IEC 60601-2-20:2020 includes the following significant technical change with respect to the previous edition: re-dating of normative references.

Standard NumberBS EN IEC 60601-2-20:2020
TitleMedical electrical equipment. Particular requirements for the basic safety and essential performance of infant transport incubators
Publication Date09 October 2020
Normative References(Required to achieve compliance to this standard)IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005, EN 60601-1:2006/A12:2014, EN 60601-1:2006, IEC 60601-1-2:2014, EN 60601-1:2006/A1:2013, EN 60601-1:2006/corrigendum Mar. 2010, EN 60601-1-2:2015, ISO 407, ISO 32
Informative References(Provided for Information)EN 61672-1, IEC 60601-2-50, EN 60601-1-10, IEC 60601-1-10, ISO 80601-2-56, EN ISO 80601-2-56, EN 60601-2-50, IEC 61672-1, FprEN IEC 60601-2-19:2020, IEC 60601-2-35:2020, IEC 60601-2-21:2020, BS EN IEC 60601-2-35:2020, BS EN IEC 60601-2-21:2020, IEC 60601-2-19:2020
ReplacesBS EN 60601-2-20:2009+A1:2016
International RelationshipsEN IEC 60601-2-20:2020,IEC 60601-2-20:2020
Draft Superseded By19/30385655 DC
DescriptorsEnvironmental testing, Patient transport equipment, Electronic equipment and components, Electrical equipment, Incubators, Voltage, Environment (working), Accuracy, Incubators (infant), Electric power systems, Electrical medical equipment, Mechanical testing, Stability, Leak tests, Medical equipment, Electrical safety, Marking, Temperature, Classification systems, Safety measures, Transportable, Fire safety, Protected electrical equipment, Performance, Strength of materials, Sound intensity, Instructions for use, Performance testing, Temperature controllers, Temperature measurement, Electrical testing, Identification methods, Alarm systems, Errors, Testing conditions
Title in FrenchAppareils électromédicaux Exigences particulières pour la sécurité de base et les performances essentielles des incubateurs de transport pour nouveau-nés
Title in GermanMedizinische elektrische Geräte Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Tranportinkubatoren
ISBN978 0 539 02768 6
File Size1.277 MB

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