CAN/CSA-ISO 15883-6:17 (R2022)

CSA Preface

This is the first edition of CAN/CSA-ISO 15883-6, Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 15883-6 (first edition, 2011-04-15).

For brevity, this Standard will be referred to as “CAN/CSA-ISO 15883-6” throughout.

This Standard was reviewed for Canadian adoption by the SCC Mirror Committee to ISO/TC 198, under the jurisdiction of the CSA Technical Committee on Medical Device Reprocessing and the CSA Strategic Steering Committee on Health Care Technology & Systems, 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 part of ISO 15883 specifies particular requirements for washer-disinfectors (WDs) intended for use when the level of assurance of disinfection that is necessary can be achieved by cleaning and thermal disinfection (A0 not less than 60) and does not require an independent automated record of critical processes to be kept. It is intended to be used in conjunction with ISO 15883-1, which gives general requirements for WDs.

The range of products on which WDs of this particular type can be used is restricted to devices and equipment which are non-invasive and non-critical (i.e. not penetrating skin or contacting mucosal surfaces).

NOTE Thermal disinfection can be achieved by rinsing the load with hot water, exposure to steam or combination of the two.