CAN/CSA-ISO 15883-5:23 PDF

CSA Preface 

This is the first edition of CSA ISO 15883-5:23, Washer-disinfectors — Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 15883-5 (first edition, 2021-07). It replaces CSA Z15883-5:09 (adopted ISO/TS 15883-5:2005), Washer-disinfectors — Part 5: Test soils and methods for demonstrating cleaning efficacy. For brevity, this Standard will be referred to as “CSA ISO 15883-5” 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 the Canadian Agency for Drugs and Technologies in Health (CADTH). This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Medical Device Reprocessing, under the jurisdiction of the Strategic Steering Committee on Health 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 specifies procedures and test methods used to demonstrate the cleaning efficacy of washer-disinfectors (WD) and their accessories intended to be used for cleaning of reusable medical devices. 

NOTE 1 The requirements can be used for washer-disinfectors intended for use with other articles used in the context of medical, dental, laboratory, pharmaceutical and veterinary practice. 

NOTE 2 This document does not apply to the activities to be performed by the manufacturers of reusable medical devices.