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)

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
• Directive: 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

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2009
1DGRPHãþD
SIST EN ISO 15883-4:2008
ýLVWLOQRGH]LQIHNFLMVNHQDSUDYHGHO=DKWHYHLQSUHVNXVL]DþLVWLOQR
GH]LQIHNFLMVNHQDSUDYHVNHPLþQRGH]LQIHNFLMR]DWHUPRODELOQHHQGRVNRSH,62

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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

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 15883-4:2008 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.
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 15883-4:2008 has been approved by CEN as a EN ISO 15883-4:2009 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 (ERs) of EU Qualifying remarks/Notes
this International Directive 93/42/EEC
Standard
4.1.1
1, 2, 3, 4, 5, 6, 7.1, 7.2, 7.3, 7.5, 7.6, 8.1, 9.1, The WD shall comply with the
9.2, 9.3, 12.1, 12.5, 12.6, 12.7.1, 12.7.3, 12.7.5, requirements of ISO 15883-
13.1, 13.3, 13.4, 13.6 1:2006
4.1.2
1, 3, 4, 6, 7.1, 7.2, 7.5, 8.1, 9.1
4.1.3 1, 3, 4, 6, 7.1,7.2, 7.5, 8.1, 9.1
4.1.4 13.3 i), 13.3 k)
4.1.5 7.3, 8.1
4.1.6 7.3, 8.1
3, 7.3, 8.1, 9.1
4.1.7
4.1.8
13.4, 13.6 h), 13.3 k), 13.3 m)
4.2 3, 7.3, 7.5, 7.6, 8.1
4.3 3, 8.1
4.4 3, 8.1
4.5 3, 8.1
4.6 3, 8.1
4.7 3, 8.1
4.8
3, 9.1, 9.2
4.9 13.1, 13.6 d)
5.1
3, 9.1, 12.7.5
Table ZA.1 (continued)
Clauses/subclauses of this Essential requirements (ERs) Qualifying remarks/Notes
European Standard of EU Directive 93/42/EEC
5.2 3, 8.1, 13.1
5.3 7.2, 7.5, 8.1
5.4 3, 8.1
5.5 3, 8.1
5.6 2, 3
6.2 1, 2, 3, 6, 7.1, 8.1 Testing for conformity
6.3 3, 9.1 Testing for conformity
6.4 3, 7.3, 8.1, 9.1 Testing for conformity
6.5 3, 7.5, 8.1, 9.1 Testing for conformity
6.6 3, 7.5, 8.1 Testing for conformity
6.7 3, 8.1 Testing for conformity
6.8 3, 8.1 Testing for conformity
6.9 3, 8.1 Testing for conformity
6.10 3, 8.1 Testing for conformity
6.11 3, 8.1 Testing for conformity
6.12 3, 8.1
7 13 The requirements of ISO 15883-1:2006
apply.
8 13.1, 13.3, 13.4, 13.6 In addition, the requirements of
ISO 15883-1:2006 apply.
9 5, 13 The requirements of ISO 15883-1:2006
apply.
10 1, 3 In addition, the requirements of
ISO 15883-1:2006 apply.
- 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
4.1.1 1.1.7, 1.2.2, 1.2.3, 1.2.4, 1.2.5, 1.3.2, This relevant EHSR are
1.3.3, 1.3.4, 1.5.1, 1.5.2, 1.5.3, 1.5.5, addressed in this Standard
1.5.6, 1.5.8, 1.5.13, 1.5.14, 1.6.2,
1.6.3, 1.6.4, 1.6.5
4.1.1 1.1.3, 1.1.5, 1.1.6, 1.2.1, 1.2.6, 1.3.1, This relevant EHSR are partly
1.3.7, 1.3.8.1, 1.3.8.2, 1.5.4, 1.6.1, addressed in this Standard
1.7.1, 1.7.2, ,1.7.3, 1.7.4
1.3.9, 1.4.1, 1.4.2, 1.4.3, 1.5.9, 4 This relevant EHSR are not
addressed in this Standard
INTERNATIONAL ISO
STANDARD 15883-4
First edition
2008-05-01
Washer-disinfectors —
Part 4:
Requirements and tests for washer-
disinfectors employing chemical
disinfection for thermolabile endoscopes
Laveurs désinfecteurs —
Partie 4: Exigences et essais pour les laveurs désinfecteurs destinés à
la désinfection chimique des endoscopes thermolabiles

Reference number
ISO 15883-4:2008(E)
©
ISO 2008
ISO 15883-4:2008(E)
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ISO 15883-4:2008(E)
Contents Page
Foreword. v
Introduction . vi
1 Scope . 1
2 Normative references . 2
3 Terms and definitions. 2
4 Performance requirements . 3
4.1 General. 3
4.2 Systems for leak testing . 4
4.3 Cleaning. 6
4.4 Disinfecting . 7
4.5 Final (post-disinfection) rinsing . 9
4.6 Purging to remove rinse water. 9
4.7 Drying. 9
4.8 Self-disinfection. 10
4.9 Water treatment equipment . 11
5 Mechanical and process requirements . 12
5.1 Materials ― Design, manufactur
...