IEC 60601-2-21:2016 Appareils électromédicaux - Partie 2-21: Exigences particulières pour la sécurité de base et les performances essentielles des incubateurs radiants pour nouveau-nés (Edition 2.1; Consolidated Reprint)
Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT RADIANT WARMERS as defined in 201.3.204@ 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 the safety requirements for INFANT RADIANT WARMERS@ 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; ?C INFANT INCUBATORS; for information see IEC 60601-2-19; ?C INFANT TRANSPORT INCUBATORS@ for information see IEC 60601-2-20; ?C INFANT PHOTOTHERAPY EQUIPMENT@ for information see IEC 60601-2-50. Object Replacement: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for INFANT RADIANT WARMERS as defined in 201.3.204@ which minimize HAZARDS to PATIENT and OPERATOR@ and to specify tests by which compliance with the requirements can be verified.
IEC 60601-2-21:2016 history
0000 IEC 60601-2-21:2020/AMD1:2023 CSV
1970IEC 60601-2-21:2023 Medical electrical equipment; part 2: particular requirements for the safety of infant radiant warmers
0000 IEC 60601-2-21:2020 RLV
2016IEC 60601-2-21:2009/AMD1:2016 AMENDMENT 1 Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers (Edition 2.0)
2016IEC 60601-2-21:2016 Appareils électromédicaux - Partie 2-21: Exigences particulières pour la sécurité de base et les performances essentielles des incubateurs radiants pour nouveau-nés (Edition 2.1; Consolidated Reprint)
2013IEC 60601-2-21:2009/COR1:2013 Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
2009IEC 60601-2-21:2009 Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
1970IEC 60601-2-21:1994/AMD1:1996 Amendment 1 - Medical electrical equipment - Part 2: Particular requirements for the safety of infant radiant warmers
1994IEC 60601-2-21:1994 Medical electrical equipment; part 2: particular requirements for the safety of infant radiant warmers