CSA Preface
This is the first edition of CAN/CSA-Z15883-1, Washer-disinfectors — Part 1: General requirements, terms and definitions and tests, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 15883-1 (first edition, 2006-04-15).
This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Sterilization, under the jurisdiction of the Strategic Steering Committee on Health Care Technology, 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.
Scope
This part of ISO 15883 specifies general performance requirements for washer-disinfectors (WD) and their accessories that are intended to be used for cleaning and disinfection of re-usable medical devices and other articles used in the context of medical, dental, pharmaceutical and veterinary practice. It specifies performance requirements for cleaning and disinfection as well as for the accessories which can be required to achieve the necessary performance. The methods and instrumentation required for validation, routine control and monitoring and re-validation, periodically and after essential repairs, are also specified.
The requirements for washer-disinfectors intended to process specific loads are specified in subsequent parts of this standard. For washer-disinfectors intended to process loads of two or more different types the requirements of all relevant parts of this standard apply.
This part of ISO 15883 does not specify requirements intended for machines for use for laundry or general catering purposes.
This part of ISO 15883 does not include requirements for machines which are intended to sterilize the load, or which are designated as sterilizers, these are specified in other standards e.g. EN 285.
The specified performance requirements of this standard may not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.
NOTE If it is considered that prion protein can be present, particular care is needed in the choice of disinfectants and cleaning agents to ensure that the chemicals used do not react with the prion protein in a manner that may inhibit its removal or inactivation.
This part of ISO 15883 may be used by prospective purchasers and manufacturers as the basis of agreement on the specification of a WD. The test methods for demonstration of compliance with the requirements of this part of ISO 15883 may also be employed by users to demonstrate continued compliance of the installed WD throughout its working life. Guidance on a routine test programme is given in Annex A.
An update to this product is available.
To receive notifications when an amendment, new edition or update is available to your standard no matter how you purchased it, please register on the Standards Update Service. After registering, enter the List ID for the relevant standard. The List ID can be found in the “CSA Standards Update” section within the first few pages of the standard you’ve purchased. Once notified, you can then update your standard accordingly.
PDF Format Purchased from the CSA Store
If you have purchased or subscribed to a standard from the CSA Store in PDF format, login to your CSA OnDemandTM account to access the updated PDF.
Paper Format Purchased or Purchased from Reseller
If you have purchased a paper copy of the standard from the CSA Store or purchased a standard in paper or PDF format from one of our resellers, login to the Standards Update Service to download the updates in PDF format.
eBook Format Purchased
If you have purchased a standard in eBook format, login to the CSA Reader App to download the updated version of the standard.
Request Copyright Permissions
