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IEC 60601-2-21-ed.3.1+Amd.1-CSV
Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
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STANDARD published on 3.11.2023
The information about the standard:
Designation standards: IEC 60601-2-21-ed.3.1+Amd.1-CSV
Publication date standards: 3.11.2023
SKU: NS-1158007
The number of pages: 157
Approximate weight : 502 g (1.11 lbs)
Country: International technical standard
Category: Technical standards IEC
The category - similar standards:
Annotation of standard text IEC 60601-2-21-ed.3.1+Amd.1-CSV :
IEC 60601-2-21:2020+AMD1:2023 CSV 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 document are not covered by specific requirements in this document, except in 7.2.13 and 8.4.1 of the general standard. IEC 60601-2-21:2020 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: - devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use; for information, see IEC 60601-2-35; - INFANT INCUBATORS; for information, see IEC 60601-2-19; - INFANT TRANSPORT INCUBATORS, for information, see IEC 60601-2-20; - INFANT PHOTOTHERAPY EQUIPMENT, for information, see IEC 60601-2-50. SKIN TEMPERATURE SENSORS which are applied to operate a BABY CONTROLLED RADIANT WARMER including the displayed value are not considered to be a CLINICAL THERMOMETER in the sense of the particular standard ISO 80601-2-56. IEC 60601-2-21:2020 cancels and replaces the second edition published in 2009 and Amendment 1:2016. This edition constitutes a technical revision. IEC 60601-2-21:2020 includes the following significant technical change with respect to the previous edition: alignment with IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012. LIEC 60601-2-21:2020+AMD1:2023 CSV s’applique a la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des INCUBATEURS RADIANTS POUR NOUVEAU-NES, tels que definis au 201.3.204, egalement designes sous le terme APPAREILS EM. Si un article ou un paragraphe est specifiquement destine a etre applicable uniquement aux APPAREILS EM ou uniquement aux SYSTEMES EM, le titre et le contenu de cet article ou de ce paragraphe lindiquent. Si cela nest pas le cas, larticle ou le paragraphe sapplique a la fois aux APPAREILS EM et aux SYSTEMES EM, selon le cas. Les DANGERS inherents a la fonction physiologique prevue des APPAREILS EM ou des SYSTEMES EM dans le cadre du domaine dapplication du present document ne sont pas couverts par des exigences specifiques contenues dans le present document, a lexception de 7.2.13 et de 8.4.1 de la norme generale. LIEC 60601-2-21:2020 specifie les exigences de securite relatives aux INCUBATEURS RADIANTS POUR NOUVEAU-NES, mais des methodes alternatives de conformite a un article specifique, en demontrant un niveau equivalent de securite, ne sont pas considerees comme non conformes, si le FABRICANT a demontre dans son DOSSIER DE GESTION DES RISQUES que le RISQUE presente par le DANGER s’est revele avoir un niveau acceptable, lorsqu’il a ete evalue par rapport aux avantages du traitement presentes par le dispositif. La presente norme particuliere ne sapplique pas aux: - dispositifs delivrant de la chaleur par lintermediaire de COUVERTURES, COUSSINS ou MATELAS en usage medical; voir l’IEC 60601-2-35 a titre informatif; - INCUBATEURS POUR NOUVEAU-NES, voir l’IEC 60601-2-19 a titre informatif; - INCUBATEURS DE TRANSPORT POUR NOUVEAU-NES; voir l’IEC 60601-2-20 a titre informatif; - APPAREILS DE PHOTOTHERAPIE POUR NOUVEAU-NES, voir l’IEC 60601-2-50 a titre informatif. Les CAPTEURS DE TEMPERATURE CUTANEE appliques au fonctionnement d’un INCUBATEUR RADIANT A REGULATION CUTANEE incluant la valeur affichee ne sont pas consideres comme un THERMOMETRE MEDICAL au sens de la norme particuliere ISO 80601-2-56. LIEC 60601-2-21:2020 annule et remplace la deuxieme edition parue en 2009 et son Amendement 1 (2016). Cette edition constitue une revision technique. Cette edition inclut la modification technique majeure suivante par rapport a ledition precedente: alignement avec l’IEC 60601-1:2005 et l’IEC 60601-1:2005/AMD1:2012.
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