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IEC 60601-2-19:2020

Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators

Edition date: 2020-09-02
In Force
Available languages: English, French
Summary: IEC 60601-2-19:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT INCUBATORS, as defined in 201.3.209, 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 60601-2-19:2020 specifies safety requirements for INFANT 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.
IEC 60601-2-19:2020 does not apply to:
- INFANT TRANSPORT INCUBATORS; for information, see IEC 60601-2-20;
- INFANT RADIANT WARMERS; for information, see IEC 60601-2-21;
- devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use; for information, see IEC 60601-2-35;
- INFANT PHOTOTHERAPY EQUIPMENT; for information see IEC 60601-2-50.
SKIN TEMPERATURE SENSORS which are applied to operate a BABY CONTROLLED INCUBATOR including the displayed value are not considered to be a CLINICAL THERMOMETER in the sense of the particular standard ISO 80601-2-56. IEC 60601-2-19:2020 cancels and replaces the second edition published in 2009 and Amendment 1:2016. This edition constitutes a technical revision. IEC 60601-2-19:2020 includes the following significant technical change with respect to the previous edition: re-dating of normative references.

L'IEC 60601-2-19:2020 s'applique à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des INCUBATEURS POUR NOUVEAU-NES, tels que définis au 201.3.209, également désignés sous le terme APPAREILS EM.
Si un article ou un paragraphe est spécifiquement destiné à être applicable uniquement aux APPAREILS EM ou uniquement aux SYSTEMES EM, le titre et le contenu de cet article ou de ce paragraphe l'indiquent. Si cela n'est pas le cas, l'article ou le paragraphe s'applique à la fois aux APPAREILS EM et aux SYSTEMES EM, selon le cas.
Les DANGERS inhérents à la fonction physiologique prévue des APPAREILS EM ou des SYSTEMES EM dans le cadre du domaine d'application du présent document ne sont pas couverts par des exigences spécifiques contenues dans le présent document, à l'exception de 7.2.13 et de 8.4.1 de la norme générale.
La présente norme particulière spécifie les exigences de sécurité relatives aux INCUBATEURS POUR NOUVEAU-NES, mais des méthodes alternatives de conformité à un article spécifique, en démontrant un niveau équivalent de sécurité, ne sont pas considérées comme non conformes, si le FABRICANT a démontré dans son DOSSIER DE GESTION DES RISQUES que le RISQUE présenté par le DANGER s'est révélé avoir un niveau acceptable, lorsqu'il a été évalué par rapport aux avantages du traitement présentés par le dispositif.
La présente norme particulière ne s'applique pas aux:
– INCUBATEURS DE TRANSPORT POUR NOUVEAU-NES; voir l’IEC 60601-2-20 à titre informatif;
– INCUBATEURS RADIANTS POUR NOUVEAU-NES; voir l'IEC 60601-2-21 à titre informatif;
– dispositifs délivrant de la chaleur par l'intermédiaire de COUVERTURES, COUSSINS ou MATELAS en usage médical; voir l’IEC 60601-2-35 à titre informatif;
– APPAREILS DE PHOTOTHERAPIE POUR NOUVEAU-NES; voir l'IEC 60601-2-50 à titre informatif.
Les CAPTEURS DE TEMPERATURE CUTANEE appliqués au fonctionnement d'un INCUBATEUR A REGULATION CUTANEE incluant la valeur affichée ne sont pas considérés comme un THERMOMETRE MEDICAL au sens de la norme particulière ISO 80601-2-56.
L'IEC 60601-2-19:2020 annule et remplace la deuxième édition parue en 2009 et l'Amendement 1:2016. Cette édition constitue une révision technique.
Cette édition inclut la modification technique majeure suivante par rapport à l'édition précédente: nouvelle datation des références normatives.
ICS: 11.040.10-Anaesthetic, respiratory and reanimation equipment
CTN: TC 62/SC 62D - 1365

Standards Cancellations

Anula a IEC 60601-2-19:2009

Anula a IEC 60601-2-19:2009/COR1:2012

Anula a IEC 60601-2-19:2009/AMD1:2016

Modificaciones Normas

Es modificada por IEC 60601-2-19:2020/AMD1:2023

Otras Relaciones

Acuerdo de Frankfurt FprEN IEC 60601-2-19:2020

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