CSA ISO/TS 22583:26

N/A
CSA Preface This is the first edition of CSA ISO/TS 22583, Requirements and recommendations for supervisors and operators of point-of-care testing (POCT) equipment , which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Technical Specification 22583 (second edition, 2024-09). For brevity, this Standard will be referred to as "CSA ISO/TS 22583" throughout. CSA Group acknowledges that the adoption of this Standard was made possible, in part, by the financial support of the governments of Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Northwest Territories, Nova Scotia, Nunavut, Ontario, Prince Edward Island, Québec, Saskatchewan, and Yukon, as administered by Canada’s Drug Agency (CDA-AMC). The ISO Technical Specification was reviewed for Canadian adoption by the CSA Technical Committee on Medical Laboratory Quality Systems, under the jurisdiction of the CSA Strategic Steering Committee on Health Care and Well-being, and has been formally approved by the Technical Committee. 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. Scope This document provides requirements and recommendations for supervisors and operators of point-of-care testing (POCT) services where POCT is performed without medical laboratory training, supervision or support. It includes the key components that should be considered to provide safe and reliable POCT results. Self-testing is excluded from this document.