NF EN ISO 15883-4

Le présent document spécifie les exigences particulières, notamment les performances, relatives aux laveurs désinfecteurs (LD) destinés à être utilisés pour le nettoyage et la désinfection chimique des endoscopes thermosensibles. Il spécifie également les exigences de performance relatives au nettoyage et à la désinfection du laveur désinfecteur ainsi que de ses composants et accessoires qui peuvent être nécessaires pour atteindre les performances voulues. Le présent document peut être utilisé par des fabricants ou des acheteurs potentiels comme une base d'accord entre les spécifications des fabricants d'endoscopes, de produits de nettoyage et de produits désinfectants. Il peut également être exploité par les utilisateurs. Le présent document est une norme harmonisée rentrant dans le cadre de la Directive UE 93/42/CEE relative aux dispositifs médicaux.

<p>This document specifies the particular requirements, including performance criteria for washer-disinfectors (WD) that are intended to be used for cleaning and chemical disinfection of thermolabile endoscopes.</p> <p>This document also specifies the performance requirements for the cleaning and disinfection of the washer-disinfector and its components and accessories which can be required to achieve the necessary performance criteria.</p> <p>The methods, instrumentation and instructions required for type testing, works testing, validation (installation, operational and performance qualification on first installation), routine control and monitoring, and requalification of WD periodically and after essential repairs, are also specified.</p> <p>NOTE 1 In addition, Annex A gives guidance on an appropriate division of responsibility for the range of activities covered by this document.</p> <p>NOTE 2 WD complying with this document can also be used for cleaning and chemical disinfection of other thermolabile re-usable medical devices for which the device manufacturer has recommended and validated this method of disinfection.</p> <p>WD complying with the requirements of this document are not intended for cleaning and disinfection of medical devices, including endoscopic accessories, which are heat stable and can be disinfected or sterilized by thermal methods (see ISO 15883-1:2006+Amd 1:2014, 4.1.5).</p> <p>The specified performance requirements of this document do not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.</p> <p>NOTE 3 If it is considered that prion protein might be present, particular care is needed in the choice of cleaning agents and disinfectants to ensure that the chemicals used do not react with the prion protein and/or other protein in a manner that can inhibit its removal or inactivation from the load or washer-disinfector.</p> <p>NOTE 4 This document can be used by prospective purchasers and manufacturers as the basis of agreement on the specification of the WD, manufacturers of endoscopes, cleaning products, and disinfecting products.</p>