NF EN ISO 80601-2-67
Medical electrical equipment - Part 2-67 : particular requirements for basic safety and essential performance of oxygen-conserving equipment
This document is applicable to the basic safety and essential performance of oxygen conserving equipment, hereafter referred to as ME equipment, in combination with its accessories intended to conserve supplemental oxygen by delivering gas intermittently and synchronized with the patient's inspiratory cycle, when used in the home healthcare environment. Oxygen conserving equipment is typically used by a lay operator. NOTE 1 Conserving equipment can also be used in professional health care facilities. This document is also applicable to conserving equipment that is incorporated with other equipment. EXAMPLE Conserving equipment combined with a pressure regulator[2], an oxygen concentrator[7] or liquid oxygen equipment[4]. This document is also applicable to those accessories intended by their manufacturer to be connected to conserving equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the conserving equipment. This document is intended to clarify the difference in operation of various conserving equipment models, as well as between the operation of conserving equipment and continuous flow oxygen equipment, by requiring standardized performance testing and labelling. This document is only applicable to active devices (e.g. pneumatically or electrically powered) and is not applicable to non-active devices (e.g. reservoir cannulas). 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 IEC 60601-1:2005+AMD1:2012, 7.2.13 and 8.4.1. NOTE 2 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2.
This document is applicable to the basic safety and essential performance of oxygen conserving equipment, hereafter referred to as ME equipment, in combination with its accessories intended to conserve supplemental oxygen by delivering gas intermittently and synchronized with the patient's inspiratory cycle, when used in the home healthcare environment. Oxygen conserving equipment is typically used by a lay operator.
NOTE 1 Conserving equipment can also be used in professional health care facilities.
This document is also applicable to conserving equipment that is incorporated with other equipment.
EXAMPLE Conserving equipment combined with a pressure regulator[2], an oxygen concentrator[7] or liquid oxygen equipment[4].
This document is also applicable to those accessories intended by their manufacturer to be connected to conserving equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the conserving equipment.
This document is intended to clarify the difference in operation of various conserving equipment models, as well as between the operation of conserving equipment and continuous flow oxygen equipment, by requiring standardized performance testing and labelling.
This document is only applicable to active devices (e.g. pneumatically or electrically powered) and is not applicable to non-active devices (e.g. reservoir cannulas).
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 IEC 60601-1:2005+AMD1:2012, 7.2.13 and 8.4.1.
NOTE 2 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2.
Le présent document spécifie les prescriptions des appareils portatifs qui assurent le débit de gaz respirables durant le traitement (par exemple traitement par oxygène à long terme, analgésie) . Ces dispositifs sont destinés à économiser les gaz respirables et à accroître la sécurité et la liberté de mouvement du patient. Ces dispositifs sont utilisés à domicile ou dans les centres de soin. Ce document se lit conjointement avec la norme NF EN 60601-1 sur les règles de sécurité des appareils électromédicaux.
- Avant-propos
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201 .1* Domaine 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 Perturbations électromagnétiques - Exigences et essais
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206 Aptitude à l'utilisation
- Annexe C (informative) Guide pour les exigences de marquage et d'étiquetage pour les appareils EM et systèmes EM
- Annexe D (informative) Symboles de marquage
- Annexe AA (informative) Recommandations particulières et justifications
- Annexe BB (informative) Référence aux principes essentiels et aux recommandations d'étiquetage de l'IMDRF
- Annexe CC (informative) Référence aux principes essentiels
- Annexe DD (informative) Référence aux exigences générales de sécurité et de performances
- Annexe EE (informative) Terminologie - Index alphabétique des termes définis
- Bibliographie
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