Medical devices — Sleep apnoea breathing therapy — Masks and application accessories

CSA Group
Standards Development Organisation:
Canadian Standards Association (operating as CSA Group)
Working Program:
View the CSA work program
Designation Number:
CAN/CSA-Z17510:15
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Sub-Type
Harmonized (Joint Canada National Standard)
Standard Development Activity:
Reaffirmation
ICS code(s):
11.040.10
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

This International Standard applies to masks and their accessories used to connect sleep apnoea breathing therapy equipment to the patient. It specifies requirements for masks and accessories, including any connecting element, that are required to connect the patient-connection port of sleep apnoea breathing therapy equipment to a patient for the application of sleep apnoea breathing therapy (e.g. nasal masks, exhaust ports and headgear).

Sleep apnoea breathing therapy equipment is covered by ISO 80601-2-70. Figure A.1 shows the typical elements of this International Standard together with the sleep apnoea breathing therapy equipment of ISO 80601-2-70 that form a sleep apnoea breathing system.

Project need:

To reaffirm the Standard for the 5-year review period

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