Medical devices – sleep apnoea breathing therapy – Masks and application accessories

Designation Number:
ISO 17510
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Development Activity:
New Edition
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

ISO 17510 will replace Z17510-1 and Z17510-2

 

IEC 60601-1:1988, Clause 1 applies, except as follows.

Amendment (add at the end of the Subclause 1.1):

This part of ISO 17510 specifies requirements for equipment intended for sleep apnoea breathing therapy for domiciliary use, ships, aircraft and other transport vehicles and for use in healthcare institutions.

This part of ISO 17510 applies to equipment intended for use with adults and children, and excludes equipment intended for use with neonates.

Jet and very high frequency ventilation and oscillation are not considered in this part of ISO 17510.

This part of ISO 17510 does not apply to equipment covered by the scope of the ISO 10651 series, including:

- ISO 10651-2:2004; - ISO 10651-3:1997; - ISO 10651-4:2002; - ISO 10651-5:2006; - ISO 10651-6:2004.

This part of ISO 17510 does not apply to equipment covered by the scope of IEC 60601-2-12.

ISO 17510 covers sleep apnoea breathing therapy equipment for patient use. ISO 17510-2 applies to masks and accessories used to connect sleep apnoea breathing therapy equipment to the patient. See also Figure AA.1.

Note: The information provided above was obtained by the Standards Council of Canada (SCC) and is provided as part of a centralized, transparent notification system for new standards development. The system allows SCC-accredited Standards Development Organizations (SDOs), and members of the public, to be informed of new work in Canadian standards development, and allows SCC-accredited SDOs to identify and resolve potential duplication of standards and effort.

Individual SDOs are responsible for the content and accuracy of the information presented here. The text is presented in the language in which it was provided to SCC.