Appareils électromédicaux — Partie 2-70 : Exigences particulières pour la sécurité de base et les performances essentielles du matériel de traitement respiratoire de l’apnée du sommeil

Numéro de référence:
CAN/CSA-C22.2 NO. 80601-2-70:17
Catégorie de norme:
Norme nationale du Canada - Adoption d'une Norme internationale
Type d’activité d’élaboration de normes:
Confirmation
Code ICS:
11.040.10
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

1.1 * Scope 

IEC 60601-1:2005+A1:2012, 1.1 is replaced by: 

This particular standard is applicable to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SLEEP APNOEA BREATHING THERAPY EQUIPMENT, hereafter referred to as ME EQUIPMENT, intended to alleviate the symptoms of PATIENTS who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the PATIENT. SLEEP APNOEA BREATHING THERAPY EQUIPMENT is intended for use in the HOME HEALTHCARE ENVIRONMENT by LAY OPERATORS as well as in professional healthcare institutions. 

This particular standard excludes SLEEP APNOEA BREATHING THERAPY EQUIPMENT intended for use with neonates. 

This particular standard is applicable to ME EQUIPMENT or an ME SYSTEM intended for those PATIENTS who are not dependent on mechanical ventilation. 

This particular standard is not applicable to ME EQUIPMENT or an ME SYSTEM intended for those PATIENTS who are dependent on mechanical ventilation such as PATIENTS with central sleep apnoea. 

This particular standard is also applicable to those ACCESSORIES intended by their MANUFACTURER to be connected to SLEEP APNOEA BREATHING THERAPY EQUIPMENT, where the characteristics of those ACCESSORIES can affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the SLEEP APNOEA BREATHING THERAPY EQUIPMENT. 

MASKS and application ACCESSORIES intended for use during sleep apnoea breathing therapy are additionally addressed by ISO 17510. 3) Refer to Figure AA.1 for items covered further under this standard. 

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 7.2.13 and 8.4.1 of the general standard. 

NOTE 4 See also 4.2 of the General Standard. 

This particular standard is not applicable to high-frequency jet ventilators (HFJVs) or high-frequency oscillatory ventilators (HFOVs).[16] 

This particular standard does not specify the requirements for ventilators or ACCESSORIES intended for critical care ventilators for ventilator-dependent PATIENTS which are given in ISO 80601-2-12. 

This particular standard does not specify the requirements for ventilators or ACCESSORIES intended for anaesthetic applications which are given in IEC 80601-2-13. 

This particular standard does not specify the requirements for ventilators or ACCESSORIES intended for home care ventilators for ventilator-dependent PATIENTS which are given in ISO 10651-24). 

This particular standard does not specify the requirements for ventilators or ACCESSORIES intended for emergency and transport which are given in ISO 10651-35). 

This particular standard does not specify the requirements for ventilators or ACCESSORIES intended for homecare ventilatory support devices which are given in ISO 10651-66). 

This particular standard is a particular standard in the IEC 60601-1 and ISO/IEC 80601 series of standards. 

201.1.2 Object 

IEC 60601-1:2005, 1.2 is replaced by: 

The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for SLEEP APNOEA BREATHING THERAPY EQUIPMENT [as defined in 201.3.212].

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.