Appareils électromédicaux - Partie 2-61: Exigences particulières pour la sécurité de base et les performances essentielles pour les oxymètres de pouls

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CSA Group
Organisme d'élaboration de normes:
Programme de travail:
Numéro de référence:
CAN/CSA-C22.2 NO. 80601-2-61:14
Catégorie de norme:
Norme nationale du Canada - Adoption d'une Norme internationale
Type d’activité d’élaboration de normes:
Confirmation
Statut:
En cours d'élaboration
Date de début de la période de commentaires OEN:
Date de fin de la période de commentaires des OEN:
Affiché le:

Porté:

Champ d’application

Scope

IEC 60601-1:2005, Clause 1 applies, except as follows:

201.1.1 * Scope

Subclause 1.1 of The general standard is replaced by:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PULSE OXIMETER EQUIPMENT intended for use on humans, hereafter referred to as ME EQUIPMENT. This includes any part necessary for NORMAL USE, including the PULSE OXIMETER MONITOR, PULSE OXIMETER PROBE, and PROBE CABLE EXTENDER.

These requirements also apply to PULSE OXIMETER EQUIPMENT, including PULSE OXIMETER MONITORS, PULSE OXIMETER PROBES and PROBE CABLE EXTENDERS, which have been REPROCESSED.

The intended use of PULSE OXIMETER EQUIPMENT includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate of PATIENTS in professional healthcare institutions as well as PATIENTS in the HOME HEALTHCARE ENVIRONMENT.

This International Standard is not applicable to PULSE OXIMETER EQUIPMENT intended for use in laboratory research applications nor to oximeters that require a blood sample from the PATIENT.

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 201.11 and in 7.2.13 and 8.4.1 of the general standard.

NOTE See also 4.2 of the general standard.

This Standard can also be applied to PULSE OXIMETER EQUIPMENT and their ACCESSORIES used for compensation or alleviation of disease, injury or disability.

This International Standard is not applicable to PULSE OXIMETER EQUIPMENT intended solely for foetal use.

This International Standard is not applicable to remote or slave (secondary) devices that display SpO2 values that are located outside of the PATIENT ENVIRONMENT.

201.1.2 Object

Subclause 1.2 of The general standard is replaced by:

The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for PULSE OXIMETER EQUIPMENT [as defined in 201.3.216] and its ACCESSORIES.

NOTE ACCESSORIES are included because the combination of the PULSE OXIMETER MONITOR and the ACCESSORIES needs to be safe. ACCESSORIES can have a significant impact on the BASIC SAFETY and ESSENTIAL PERFORMANCE of PULSE OXIMETER EQUIPMENT

Raison d’être du projet

Raison d’être du projet
To review the Standard within the required 5 year period.

Note : L’information ci-dessus a été recueillie et est diffusée par le Conseil canadien des normes (CCN) pour les besoins de son système de notification centralisé et transparent pour l’élaboration de nouvelles normes. Le système permet aux organismes d’élaboration de normes (OEN) accrédités par le CCN et aux membres du public d’être informés des nouveaux travaux d’élaboration de normes au Canada. Il donne aussi aux OEN accrédités la possibilité de repérer et de résoudre les cas de doubles emplois éventuels dans les normes et les travaux de normalisation.

Les OEN sont eux-mêmes responsables du contenu et de l’exactitude de l’information présentée ici. Cette information n’existe que dans la langue dans laquelle elle a été fournie au CCN.