NF EN ISO 15883-1
Washer-disinfectors - Part 1 : general requirements, terms and definitions and tests
ISO 15883-1:2006 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 ISO 15883. For washer-disinfectors intended to process loads of two or more different types the requirements of all relevant parts of this standard apply. ISO 15883-1:2006 does not specify requirements intended for machines for use for laundry or general catering purposes. ISO 15883-1:2006 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. ISO 15883-1:2006 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 ISO 15883-1:2006 may also be employed by users to demonstrate continued compliance of the installed WD throughout its working life. Guidance on a routine test programme also is given.
ISO 15883-1:2006 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 ISO 15883. For washer-disinfectors intended to process loads of two or more different types the requirements of all relevant parts of this standard apply.
ISO 15883-1:2006 does not specify requirements intended for machines for use for laundry or general catering purposes.
ISO 15883-1:2006 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.
ISO 15883-1:2006 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 ISO 15883-1:2006 may also be employed by users to demonstrate continued compliance of the installed WD throughout its working life. Guidance on a routine test programme also is given.
<p>ISO 15883-1:2006 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.</p> <p>The requirements for washer-disinfectors intended to process specific loads are specified in subsequent parts of ISO 15883. For washer-disinfectors intended to process loads of two or more different types the requirements of all relevant parts of this standard apply.</p> <p>ISO 15883-1:2006 does not specify requirements intended for machines for use for laundry or general catering purposes.</p> <p>ISO 15883-1:2006 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.</p> <p>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.</p> <p>ISO 15883-1:2006 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 ISO 15883-1:2006 may also be employed by users to demonstrate continued compliance of the installed WD throughout its working life. Guidance on a routine test programme also is given. </p>
- Avant-proposv
- Introductionvi
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1 Domaine d'application1
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2 Références normatives1
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3 Termes et définitions2
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4 Exigences de performances8
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4.1 Généralités8
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4.2 Nettoyage10
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4.3 Désinfection11
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4.4 Rinçage11
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4.5 Séchage12
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4.6 Produits chimiques12
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5 Exigences mécaniques et de procédé13
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5.1 Matériaux, conception et fabrication/construction13
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5.2 Sécurité14
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5.3 Calorifères et réservoirs14
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5.4 Portes de chargement et de déchargement et leurs contrôles15
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5.5 Canalisations et accessoires17
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5.6 Systèmes d'aspersion18
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5.7 Systèmes de dosage18
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5.8 Protection thermique de la charge19
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5.9 Limites du contrôle thermique du procédé19
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5.10 Commutateurs, indicateurs et dispositifs de signalisation20
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5.11 Vérification de procédé21
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5.12 Instrumentation et mécanismes de contrôle22
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5.13 Indicateurs de température23
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5.14 Indicateurs de pressions24
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5.15 Équipement de chronométrage24
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5.16 Indicateur de cycle24
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5.17 Instruments d'enregistrement (si installés)25
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5.18 Systèmes de contrôle27
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5.19 Désactivation de l'automate28
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5.20 Systèmes de contrôle par microprocesseur28
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5.21 Accès au logiciel29
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5.22 Système d'indication des défauts29
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5.23 Alimentation en eau29
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5.24 Évacuation et systèmes de vidange30
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5.25 Évacuation31
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5.26 Filtres à air installés sur le LD31
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5.27 Système de manutention et supports de charge utilisés à l'intérieur du LD31
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5.28 Chariots32
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5.29 Environnement33
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6 Essais de conformité33
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6.1 Généralités33
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6.2 Équipement d'essai36
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6.3 Essais sur les portes, les systèmes de verrouillage et les indications de défauts37
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6.4 Essais de qualité d'eau et de volume d'eau40
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6.5 Essais sur les canalisations41
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6.6 Essais sur l'instrumentation intégrée au LD44
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6.7 Essais sur les supports de charge44
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6.8 Essais thermométriques45
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6.9 Essais de dosage des produits chimiques48
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6.10 Essais d'efficacité du nettoyage49
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6.11 Essais de la qualité de l'air51
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6.12 Essai de séchage de la charge51
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6.13 Essai du contrôle automatique52
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7 Documentation53
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8 Informations devant être fournies par le fabricant53
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8.1 Généralités53
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8.2 Avant la livraison du LD et pour l'installation54
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8.3 À la livraison du LD55
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9 Marquage, étiquetage et emballage56
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9.1 Marquage et étiquetage56
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9.2 Emballage56
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10 Informations devant être demandées par le fabricant du LD à l'acheteur56
- Annexe A (informative) Programme d'essai58
- Annexe B (informative) Concept du Ao - Létalité comparée de procédés de désinfection par la chaleur humide62
- Annexe C (normative) Méthodes d'essai pour la détection et l'évaluation de souillure protéinique résiduelle66
- Annexe D (normative) Milieu de récupération pour l'estimation de la contamination bactérienne de l'eau72
- Bibliographie73
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