CAN/CSA-Z17510:15 (ISO 17510:2015, MOD)

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). For brevity, this Standard will be referred to as “CAN/CSA-Z17510“ throughout. 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 is considered suitable for use for conformity assessment within the stated scope of the Standard. This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Perioperative Safety, under the jurisdiction of the CSA Strategic Steering Committee on Health Care Technology & Systems, and has been formally approved by the Technical Committee. This Standard has been approved as a National Standard of Canada by the Standards Council of Canada.