CAN/CSA-ISO 15883-7:17 (R2022)

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Performance requirements
5 Mechanical requirements
6 Testing for conformity
7 Documentation
8 Information to be provided by the manufacturer
9 Marking, labelling, and packaging
10 Information to be requested from the purchaser by the
   manufacturer
Annex A (normative) - Summary of test programmes
Annex B (normative) - Methods for microbiological
        evaluation of disinfection of liquid transport
        system
Annex C (normative) - Tests for microbiological
        contamination of post-disinfection rinse water
Annex D (normative) - Preparation and evaluation of
        indicators for microbiological testing of the
        efficacy of chemical disinfection of the load
Annex E (informative) - Examples of test locations
        for the tests with biological indicators
Bibliography

Defines the particular requirements for washer-disinfectors (WD) intended to be used for the cleaning and chemical disinfection, in a single operating cycle, of reusable items.

CSA Preface This is the first edition of CAN/CSA-ISO 15883-7, Washer-disinfectors — Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 15883-7 (first edition, 2016-02-01). For brevity, this Standard will be referred to as “CAN/CSA-ISO 15883-7” 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 the particular requirements for washer-disinfectors (WD) intended to be used for the cleaning and chemical disinfection, in a single operating cycle, of reusable items such as the following: a) bedframes; b) bedside tables; c) transport carts; d) containers; e) surgical tables; f) sterilization containers; g) surgical clogs; h) wheelchairs, aids for the disabled. This part of ISO 15883 also specifies the performance requirements for the cleaning and disinfection of the washer-disinfector and its components and accessories which may be necessary in order to achieve the required performance. Devices identified within the scopes of ISO 15883-2, ISO 15883-3, ISO I5883-4, and ISO 15883-6 do not fall within the scope of this part of ISO 15883. In addition, the methods are specified, as well as instrumentation and instructions required for type testing, works testing, validation (installation, operation, and performance qualification on first installation), routine control, and monitoring, as well as requalifications required to be carried out periodically and after essential repairs. NOTE WDs corresponding to this part of ISO 15883 can also be used for cleaning and chemical disinfection of other thermolabile and reusable devices as recommended by the device manufacturer. The performance requirements specified in this part of ISO 15883 may not ensure the inactivation or removal of the causative agent(s) (prion proteins) of Transmissible Spongiform Encephalopathies.