Washer-disinfectors — Part 1: General requirements, terms and definitions and tests
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Organisme d'élaboration de normes:
Programme de travail:
Numéro de référence:
CAN/CSA-Z15883-1-09, Proposed Reaffirmation
Statut:
En cours d'élaboration
Date de début de la période de commentaires OEN:
Date de fin de la période de commentaires des OEN:
Affiché le:
Porté:
Champ d’application
1 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.
Note : L’information ci-dessus a été recueillie et est diffusée par le Conseil canadien des normes (CCN) pour les besoins de son système de notification centralisé et transparent pour l’élaboration de nouvelles normes. Le système permet aux organismes d’élaboration de normes (OEN) accrédités par le CCN et aux membres du public d’être informés des nouveaux travaux d’élaboration de normes au Canada. Il donne aussi aux OEN accrédités la possibilité de repérer et de résoudre les cas de doubles emplois éventuels dans les normes et les travaux de normalisation.
Les OEN sont eux-mêmes responsables du contenu et de l’exactitude de l’information présentée ici. Cette information n’existe que dans la langue dans laquelle elle a été fournie au CCN.