EN ISO 15883-1:2009
(Main)Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006)
Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006)
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.
Reinigungs-Desinfektionsgeräte - Teil 1: Allgemeine Anforderungen, Begriffe und Prüfverfahren (ISO 15883-1:2006)
Dieser Teil von ISO 15883 legt allgemeine Leistungsanforderungen an Reinigungs-Desinfektionsgeräte
(RDG) und deren Zubehör fest, die für die Reinigung und Desinfektion wieder verwendbarer Medizinprodukte
und anderer in der medizinischen, zahnmedizinischen, pharmazeutischen und veterinärmedizinischen Praxis
verwendeter Artikel vorgesehen sind. Sie legt die Leistungsanforderungen für die Reinigung und Desinfektion
sowie für das Zubehör fest, die zum Erreichen der erforderlichen Leistung notwendig sein können. Ebenso
werden die Verfahren und Messgeräte festgelegt, die für die Validierung, die Routineüberprüfung sowie,
Routineüberwachung und die Revalidierung, die in periodischen Abständen und nach wesentlichen Reparaturen
erfolgt, benötigt werden.
Die Anforderungen an die zur Behandlung spezifischer Beladungsgüter bestimmten RDG sind in folgenden
Teilen dieser Norm festgelegt. Für Reinigungs-Desinfektionsgeräte, die für die Behandlung von zwei oder
mehreren Arten von Beladungsgütern bestimmt sind, gelten die Anforderungen aller sie betreffenden Teile
dieser Norm.
Dieser Teil von ISO 15883 legt keine Anforderungen für Geräte fest, die für die Anwendung in Wäschereien
oder im Bereich der Lebensmittelzubereitung bestimmt sind.
Dieser Teil von ISO 15883 enthält keine Anforderungen an Geräte, die für die Sterilisation der Beladung
bestimmt sind oder als „Sterilisatoren“ bezeichnet werden; diese sind in anderen Normen, z. B. EN 285, festgelegt.
Es ist möglich, dass die in dieser Norm festgelegten Leistungsanforderungen nicht die Inaktivierung oder Beseitigung
von Erregern übertragbarer spongiformer Enzephalopathien (Prionenproteine) sicherstellen können.
Laveurs désinfecteurs - Partie 1: Exigences générales, termes et définitions et essais (ISO 15883-1:2006)
L'ISO 15883-1:2006 spécifie les exigences générales de performances pour les laveurs désinfecteurs (LD) et leurs accessoires destinés à être utilisés pour nettoyer et désinfecter des dispositifs médicaux réutilisables ou tout autre article utilisé dans le contexte d'activités médicales, pharmaceutiques, dentaires et vétérinaires. Elle spécifie les exigences de performances pour le nettoyage et la désinfection ainsi que pour les accessoires qui peuvent être nécessaires pour atteindre les performances requises. Les méthodes et l'instrumentation nécessaires pour la validation, le contrôle de routine, la surveillance et la revalidation, réalisés périodiquement et après des réparations essentielles, sont aussi spécifiées.
Les exigences pour les laveurs désinfecteurs destinés à traiter des charges spécifiques sont spécifiées dans des parties subséquentes de l'ISO 15883. Les laveurs désinfecteurs destinés à traiter des charges d'au moins deux types différents doivent satisfaire les exigences de toutes les parties applicables de la présente norme.
L'ISO 15883-1:2006 ne spécifie aucune exigence concernant les laveurs désinfecteurs utilisés en blanchisserie ou en restauration générale.
L'ISO 15883-1:2006 n'inclut aucune exigence pour les laveurs désinfecteurs destinés à stériliser la charge ou considérés comme des «stérilisateurs»: celles-ci sont spécifiées dans d'autres normes, par exemple l'EN 285.
Les exigences de performance spécifiées dans cette norme peuvent ne pas assurer l'inactivation ou l'élimination de(s) l'agent(s) infectieux (protéine du prion) des encéphalopathies spongiformes transmissibles.
L'ISO 15883-1:2006 peut être utilisée par des acheteurs potentiels et des fabricants sur la base de l'accord sur la spécification d'un LD. Les méthodes d'essai pour la démonstration de conformité aux exigences de l'ISO 15883-1:2006 peuvent également être utilisées par les utilisateurs afin de démontrer une conformité continue du LD installé, au cours de sa durée vie. Des directives sur un programme d'essai de routine sont données dans l'Annexe A.
Čistilno-dezinfekcijske naprave - 1. del: Osnovne zahteve, termini, definicije in preskusi (ISO 15883-1:2006)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2009
1DGRPHãþD
SIST EN ISO 15883-1:2006
ýLVWLOQRGH]LQIHNFLMVNHQDSUDYHGHO 2VQRYQH]DKWHYHWHUPLQLGHILQLFLMHLQ
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Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO
15883-1:2006)
Reinigungs-Desinfektionsgeräte - Teil 1: Allgemeine Anforderungen, Begriffe und
Prüfverfahren (ISO 15883-1:2006)
Laveurs désinfecteurs - Partie 1: Exigences générales, termes et définitions et essais
(ISO 15883-1:2006)
Ta slovenski standard je istoveten z: EN ISO 15883-1:2009
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 15883-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2009
ICS 11.080.10 Supersedes EN ISO 15883-1:2006
English Version
Washer-disinfectors - Part 1: General requirements, terms and
definitions and tests (ISO 15883-1:2006)
Laveurs désinfecteurs - Partie 1: Exigences générales, Reinigungs-Desinfektionsgeräte - Teil 1: Allgemeine
termes et définitions et essais (ISO 15883-1:2006) Anforderungen, Begriffe und Prüfverfahren (ISO 15883-
1:2006)
This European Standard was approved by CEN on 16 May 2009.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15883-1:2009: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
Foreword
The text of ISO 15883-1:2006 has been prepared by Technical Committee ISO/TC 198 “Sterilization of health
care products” of the International Organization for Standardization (ISO) and has been taken over as EN ISO
15883-1:2009 by Technical Committee CEN/TC 102 “Sterilizers for medical purposes” the secretariat of which
is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by December 2009, and conflicting national standards shall be withdrawn
at the latest by March 2010.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 15883-1:2006.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EC Directive.
For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 15883-1:2006 has been approved by CEN as a EN ISO 15883-1:2009 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential Requirements of
EU Directive 93/42/EEC
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC on medical
devices
Clauses/subclauses of Essential requirements Qualifying remarks/Notes
thisEuropean Standard (ERs)of EU Directive
93/42/EEC
1, 4, 3, 6, 7.1, 8.1, 9.1, 7.2, 9.2
2, 7.3
5.1
5.1.3
5.1.7 7.5
5.1.8 7.5
5.2 1, 2, 6, 7.1, 7.2, 7.3, 7.5, 8.1, 9.1, The WD shall comply with the
9.2, 9.3, 12.5, 12.6, 12.7.1, 12.7.2,
requirements of IEC 61010-2-045
12.7.3, 12.7.4, 12.7.5, 13.1
5.4 7.5 Refers only to leakage
5.4.1.2 7.2, 7.5
5.4.1.3 13.1
5.4.1.5 1, 2
5.4.1.6 1, 2
5.4.1.7 1, 2
5.4.1.8 1, 2
5.4.2 13.1
5.4.3 8.1
5.4.4 8.1
5.4.5.2 2
5.4.5.3 2, 7.5
Table ZA.1 (continued)
Clauses/subclauses of Essential requirements Qualifying remarks/Notes
thisEuropean Standard (ERs)of EU Directive
93/42/EEC
5.5.1 2, 7.2
5.5.2 2
5.7 3, 7.2, 7.3
5.8 2, 12.1, 12.7.5
5.9 3
5.10. 13.2
5.11.1 3
5.11.2 2, 3
5.11.3 2, 3 The choice of process verification
system shall be based on a
documented risk analysis
5.11.4 2, 3
5.12 3, 12.9
5.13 3
5.14 3
5.15 3
5.16 3
5.17 3
5.18 3
5.19 3
5.20 12.1
5.21 12.1
5.22 2, 3
5.23 3, 13.1
5.24 7.2, 7.5
5.25 7.2, 7.5
5.27 3
5.28 3
Table ZA.1 (continued)
Clauses/subclauses of Essential requirements Qualifying remarks/Notes
thisEuropean Standard (ERs)of EU Directive
93/42/EEC
5.29 3
6.1 1, 2, 3, 6, 7.1, 8.1 Testing for conformity
6.2 1, 2, 3, 6, 7.1, 8.1 Testing for conformity
6.3.5 2, 3
6.3.6 2, 3
6.3.7 2, 3
6.4 3
6.5.3 7.5
6.5.4 3
6.5.5 3
6.5.6 3
6.6 3
6.7 3
6.8 3
6.9 3, 7.3
6.10 3, 7.2, 7.5
6.11 3, 7.2, 7.5
6.12 3, 7.2, 7.5
6.13 3, 7.2, 7.5
7 13
8 13.1, 13.3, 13.4, 13.6
9 5, 13.3
10 1
- 12.1a) This relevant Essential Requirement is
not addressed in this European
Standard
7, 8, 9 13.3 a) This relevant Essential Requirement is
partly addressed in this European
Standard
- 13.6 q) This relevant Essential Requirement is
not addressed in this European
Standard
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the
scope of this standard.
For devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC on Machinery,
in accordance with Article 3 of Directive 93/42/EEC the following table ZA.2 details the relevant essential
requirements of Directive 2006/42/EC on Machinery to the extent to which they are more specific than those
of Directive 93/42/EEC along with the corresponding clauses of this European Standard. Table ZA.2,
however, does not imply any citation in the OJEU under the machinery directive and thus does not provide
presumption of conformity for the machinery directive.
Table ZA.2 – Relevant Essential Health and Safety Requirements from Directive 2006/42/EC on
machinery that are addressed by this European Standard
(according to article 3 of amended Directive 93/42/EEC)
Clause(s)/sub-clause(s) of this Essential Health and Safety Qualifying remarks/Notes
EN Requirements (EHSRs) of
Directive 2006/42/EC
5.1.1, 5.2, 5.3.2.1 a) 1.1.3 This relevant EHSR is partly
addressed in this Standard
9.2 1.1.5 This relevant EHSR is partly
addressed in this Standard
5.12.3, 6.6.2 1.1.6 This relevant EHSR is partly
addressed in this Standard
5.2 1.1.7 This relevant EHSR is addressed
in this Standard
5.12.1 1.2.1 This relevant EHSR is partly
addressed in this Standard
5.2, 5.18, 5.19 1.2.2 This relevant EHSR is addressed
in this Standard
5.2 1.2.3 This relevant EHSR is addressed
in this Standard
5.2, 5.18.5.19 1.2.4 This relevant EHSR is addressed
in this Standard
5.18, 5.19 1.2.5 This relevant EHSR is addressed
in this Standard
5.2 1.2.6 This relevant EHSR is partly
addressed in this Standard
5.4.1.5, 5.18.4, 5.22, 6.3.5, 6.3.7 1.3.1 This relevant EHSR is partly
addressed in this Standard
5.1, 5.2, 8.3 g) 1.3.2 This relevant EHSR is addressed
in this Standard
5.2 1.3.3 This relevant EHSR is addressed
in this Standard
5.2, 5.6 1.3.4 This relevant EHSR is addressed
in this Standard
5.2 1.3.7 This relevant EHSR is partly
addressed in this Standard
5.2 1.3.8.1 This relevant EHSR is partly
addressed in this Standard
5.2 1.3.8.2 This relevant EHSR is partly
addressed in this Standard
1.3.9 This relevant EHSR is not
addressed in this Standard
1.4.1 This relevant EHSR is not
addressed in this Standard
1.4.2 This relevant EHSR is not
addressed in this Standard
Table ZA.2 (continued)
Clause(s)/sub-clause(s) of this Essential Health and Safety Qualifying remarks/Notes
EN Requirements (EHSRs) of
Directive 2006/42/EC
1.4.3 This relevant EHSR is not
addressed in this Standard
5.2 1.5.1 This relevant EHSR is addressed
in this Standard
5.2, 6.3.1 1.5.2 This relevant EHSR is addressed
in this Standard
5.2 1.5.3 This relevant EHSR is addressed
in this Standard
5.2 1.5.4 This relevant EHSR is partly
addressed in this Standard
5.2 1.5.5 This relevant EHSR is addressed
in this Standard
5.2 1.5.6 This relevant EHSR is addressed
in this Standard
5.2 1.5.8 This relevant EHSR is addressed
in this Standard
1.5.9 This relevant EHSR is not
addressed in this Standard
5.2 1.5.13 This relevant EHSR is addressed
in this Standard
5.2, 5.4.1.7 1.5.14 This relevant EHSR is addressed
in this Standard
5.2, 8.3 g) 1.6.1 This relevant EHSR is partly
addressed in this Standard
5.1.5 1.6.2 This relevant EHSR is addressed
in this Standard
5.2 1.6.3 This relevant EHSR is addressed
in this Standard
5.1.5 1.6.4 This relevant EHSR is addressed
in this Standard
5.1.5 1.6.5 This relevant EHSR is addressed
in this Standard
5.2, 5.10, 5.10.3, 5.12.3, 5.22, 1.7.1 This relevant EHSR is partly
8.3 a), 8.3 b) addressed in this Standard
5.2 1.7.2 This relevant EHSR is partly
addressed in this Standard
5.2, 9.1 1.7.3 This relevant EHSR is partly
addressed in this Standard
5.2, 8.3, 9.1 1.7.4 This relevant EHSR is partly
addressed in this Standard
4 This relevant EHSR is not
addressed in this standard
INTERNATIONAL ISO
STANDARD 15883-1
First edition
2006-04-15
Washer-disinfectors —
Part 1:
General requirements, terms
and definitions and tests
Laveurs désinfecteurs —
Partie 1: Exigences générales, termes et définitions et essais
Reference number
ISO 15883-1:2006(E)
©
ISO 2006
ISO 15883-1:2006(E)
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ISO 15883-1:2006(E)
Contents Page
Foreword. v
Introduction .
...
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