NF EN ISO 11197
Medical supply units
IEC 60601-1:2005+A1:2012, 1.1 is replaced by: This document applies to the basic safety and essential performance of medical supply units, hereafter also referred to as ME equipment. This document applies to medical supply units manufactured within a factory or assembled on site, including cabinetry and other enclosures, which incorporate patient care services. NOTE 1 A party that assembles on site various components intended for patient care services into an enclosure is considered the manufacturer of the medical supply unit. Hazards inherent in the intended function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this standard, except in of IEC 60601-1:2005+A1:2012, 7.2.13 and 8.4.1 (see 201.1.4). NOTE 2 Refer to IEC 60601-1:2005+A1:2012, 4.2.
IEC 60601-1:2005+A1:2012, 1.1 is replaced by:
This document applies to the basic safety and essential performance of medical supply units, hereafter also referred to as ME equipment.
This document applies to medical supply units manufactured within a factory or assembled on site, including cabinetry and other enclosures, which incorporate patient care services.
NOTE 1 A party that assembles on site various components intended for patient care services into an enclosure is considered the manufacturer of the medical supply unit.
Hazards inherent in the intended function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this standard, except in of IEC 60601-1:2005+A1:2012, 7.2.13 and 8.4.1 (see 201.1.4).
NOTE 2 Refer to IEC 60601-1:2005+A1:2012, 4.2.
<p><i>IEC 60601-1:2005+A1:2012, 1.1 is replaced by: </i></p> <p>ISO 11197:2016 applies to the basic safety and essential performance of medical supply units, hereafter also referred to as me equipment.</p> <p>ISO 11197:2016 applies to medical supply units manufactured within a factory or assembled on site, including cabinetry and other enclosures, which incorporate patient care services. </p> <p>NOTE 1 A party that assembles on site various components intended for patient care services into an enclosure is considered the manufacturer of the medical supply unit.</p> <p>Hazards inherent in the intended function of me equipment or me systems within the scope of this International Standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of IEC 60601-1:2005+A1:2012 (see 201.1.4).</p> <p>NOTE 2 See also IEC 60601-1:2005+A1:2012, 4.2.</p>
- Avant-propos
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201 .1Domaine d'application, objet et normes connexes
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201 .2 Références normatives
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201 .3 Termes et définitions
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202 Appareils électromédicaux - Parties 1-2: exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: perturbations électromagnétiques - Exigences et essais
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206 Appareils électromédicaux - Parties 1-6: exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: aptitude à l'utilisation
- Annexe AA (informative) Justifications
- Annexe BB (informative) Essai lors de la production
- Annexe CC (informative) Documentation
- Annexe DD (informative) Terminologie - Index alphabétique des termes définis
- Bibliographie
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