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CEN

EN ISO 15883-4:2009

(Main)

Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008)

Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008)

ISO 15883-4:2008 specifies the particular requirements, including performance, for washer-disinfectors (WDs) that are intended to be used for cleaning and chemical disinfection of thermolabile endoscopes.
ISO 15883-4:2008 also specifies the performance requirements for the cleaning and disinfection of the washer-disinfector and its components and accessories which may be required to achieve the necessary performance.
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 re-validation, periodically and after essential repairs, are also specified.
ISO 15883-4:2008 can be used by prospective purchasers and manufacturers as the basis of agreement on the specification of WD manufacturers of endoscopes, cleaning products, disinfecting products, and also by users.

Reinigungs-Desinfektionsgeräte - Teil 4: Anforderungen und Prüfverfahren für Reinigungs-Desinfektionsgeräte mit chemischer Desinfektion für thermolabile Endoskope (ISO 15883-4:2008)

Dieser Teil von ISO 15883 legt die besonderen Anforderungen an Reinigungs-Desinfektionsgeräte (RDG)
einschließlich der Leistung fest, die für das Reinigen und die chemische Desinfektion von thermolabilen
Endoskopen vorgesehen sind.
Dieser Teil von ISO 15883 legt außerdem die Leistungsanforderungen an das Reinigen und die Desinfektion
des Reinigungs-Desinfektionsgeräts sowie von dessen Bauteilen und Zubehör fest, die zum Erreichen der
erforderlichen Leistung erforderlich sein können.
Des Weiteren sind die Verfahren, Ausrüstung und Anweisungen festgelegt, die für die Typprüfung,
Werksprüfung, Validierung (Installation, Betriebs- und Leistungsbeurteilung nach erstmaliger Installation),
Routinekontrolle und Überwachung sowie die regelmäßig und nach größeren Reparaturen durchzuführende
Revalidierung erforderlich sind.
ANMERKUNG 1 Zusätzlich gibt Anhang A einen Leitfaden für eine geeignete Aufteilung der Verantwortlichkeiten für die
in diesem Teil der ISO 15883 erfassten Tätigkeiten.
ANMERKUNG 2 RDG, die diesem Teil von ISO 15883 entsprechen, können auch zum Reinigen und zur chemischen
Desinfektion von anderen thermolabilen und wiederverwendbaren medizinischen Geräten verwendet werden, bei denen
der Hersteller der Geräte dieses Desinfektionsverfahren empfohlen hat.
RDG, die den Anforderungen dieses Teils von ISO 15883 entsprechen, sind nicht zum Reinigen und
Desinfizieren medizinischer Geräte, einschließlich endoskopischen Zubehörs, vorgesehen, die hitzebeständig
sind und durch thermische Verfahren (siehe ISO 15883-1:2006, 4.1.5) desinfiziert oder sterilisiert werden
können.
Es ist möglich, dass die in diesem Teil von ISO 15883 festgelegten Leistungsanforderungen nicht die
Inaktivierung oder die Beseitigung des (der) verursachenden Agens (Agenzien) (Prionenproteine) von
transmissiblen spongiformen Enzephalopathien sicherstellen.

Laveurs désinfecteurs - Partie 4: Exigences et essais pour les laveurs désinfecteurs destinés à la désinfection chimique des endoscopes thermolabiles (ISO 15883-4:2008)

L'ISO 15883-4:2008 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.
L'ISO 15883-4:2008 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.
Les méthodes, l'instrumentation et les instructions nécessaires pour les essais de type, de fonctionnement, la validation (qualification opérationnelle de l'installation et des performances lors de la première installation), le contrôle de routine, la surveillance et la revalidation, réalisés périodiquement et après des réparations essentielles, sont également spécifiés.
L'ISO 15883-4:2008 peut être utilisée 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. Elle peut également être exploitée par les utilisateurs.

Čistilno-dezinfekcijske naprave - 4. del: Zahteve in preskusi za čistilno-dezinfekcijske naprave s kemično dezinfekcijo za termolabilne endoskope (ISO 15883-4:2008)

General Information

Status
Withdrawn
Publication Date
02-Jun-2009
Withdrawal Date
18-Dec-2018
ICS
11.080.10 - Sterilizing equipment
Technical Committee
CEN/TC 102 - Sterilizers for medical purposes
Drafting Committee
CEN/TC 102/WG 8 - Performance requirements and testing for washer-disinfectors
Current Stage
9960 - Withdrawal effective - Withdrawal
Completion Date
19-Dec-2018
Directive
2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
Ref Project
SIST EN ISO 15883-4:2009 - Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008)

Relations

Replaces
EN ISO 15883-4:2008 - Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008)
Effective Date
06-Jun-2009
Replaced By
EN ISO 15883-4:2018 - Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2018)
Effective Date
26-Dec-2018

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 15883-4:2009
01-september-2009
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SIST EN ISO 15883-4:2008
ýLVWLOQRGH]LQIHNFLMVNHQDSUDYHGHO=DKWHYHLQSUHVNXVL]DþLVWLOQR
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Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing
chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008)
Reinigungs-Desinfektionsgeräte - Teil 4: Anforderungen und Prüfverfahren für
Reinigungs-Desinfektionsgeräte mit chemischer Desinfektion für thermolabile Endoskope
(ISO 15883-4:2008)
Laveurs désinfecteurs - Partie 4: Exigences et essais pour laveurs désinfecteurs
destinés à la désinfection chimique des endoscopes thermolabiles (ISO 15883-4:2008)
Ta slovenski standard je istoveten z: EN ISO 15883-4:2009
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
SIST EN ISO 15883-4:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 15883-4:2009

---------------------- Page: 2 ----------------------

SIST EN ISO 15883-4:2009
EUROPEAN STANDARD
EN ISO 15883-4
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2009
ICS 11.080.10 Supersedes EN ISO 15883-4:2008
English Version
Washer-disinfectors - Part 4: Requirements and tests for
washer-disinfectors employing chemical disinfection for
thermolabile endoscopes (ISO 15883-4:2008)
Laveurs désinfecteurs - Partie 4: Exigences et essais pour Reinigungs-Desinfektionsgeräte - Teil 4: Anforderungen
les laveurs désinfecteurs destinés à la désinfection und Prüfverfahren für Reinigungs-Desinfektionsgeräte mit
chimique des endoscopes thermolabiles (ISO 15883- chemischer Desinfektion für thermolabile Endoskope (ISO
4:2008) 15883-4:2008)
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 15883-4:2009: E
worldwide for CEN national Members.

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SIST EN ISO 15883-4:2009
EN ISO 15883-4:2009 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

2

---------------------- Page: 4 ----------------------

SIST EN ISO 15883-4:2009
EN ISO 15883-4:2009 (E)
Foreword
The text of ISO 15883-4:2008 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
15883-4:2009 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 15883-4:2008.
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.
Accord
...

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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.
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