CSA Z17510:15 (R2020)
Medical devices — Sleep apnoea breathing therapy — Masks and application accessories (Adopted ISO 17510:2015, first edition, 2015-08-01, with Canadian deviations)
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This is the first edition of CAN/CSA-Z17510, Medical devices — Sleep apnoea breathing therapy — Masks and application accessories, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 17510 (first edition, 2015-08-01). It replaces CAN/CSA-Z17510-2-10 (adopted ISO 17510-2:2007).
This Standard is intended to be used in conjunction with CAN/CSA-C22.2 No. 60601-1:14, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance (adopted IEC 60601-1:2005+A1:2012, with Canadian deviations).
This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group
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.
This International Standard does not cover oral appliances.