EN ISO 15883-4:2008
(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)
This European standard specifies the particular requirements for washer-disinfectors intended to be used for cleaning and disinfection of thermolabile re-usable medical devices including flexible endoscopes used in the context of medical, dental, pharmaceutical and veterinary practice. This standard also specifies the performance requirements for the cleaning and disinfection of the accessories which may be required for type testing, works testing, validation, routine control and monitoring and re-validation, periodically and after essential repairs are also specified.
Reinigungs-Desinfektionsgeräte - Teil 4: Anforderungen und Prüfverfahren für Reinigungs-Desinfektionsgeräte mit chemischer Desinfektion für thermolabile Endoskope (ISO/FDIS 15883-4:2007)
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)
La présente partie du prEN ISO 15883 spécifie les exigences de performances particulières pour les laveurs-désinfecteurs (LD) destinés à être utilisés pour le nettoyage et la désinfection chimique des endoscopes thermosensibles.
NOTE 1 Les LD conformes à cette partie du prEN ISO 15883 peuvent également être utilisés pour le nettoyage et la désinfection chimique d'autres dispositifs médicaux réutilisables thermosensibles pour lesquels le fabricant du dispositif a recommandé cette méthode de désinfection.
Les LD conformes aux exigences de cette partie ne sont pas destinés au nettoyage et à la désinfection des dispositifs médicaux, y compris les accessoires des endoscopes, qui sont thermostables et peuvent être désinfectés ou stérilisés par des méthodes thermiques (voir prEN ISO 15883-1:2003, 4.1.5).
Les exigences de performances spécifiées dans cette Partie ne sont pas destinées à assurer l'inactivation ou l'élimination de l'(des) agent(s) causal(s) (protéine du prion) des encéphalopathies spongiformes transmissibles.
NOTE 2 De nombreux désinfectants sont connus pour fixer les protéines et il convient d'en tenir compte lorsque la présence de la protéine du prion est possible.
Čistilno-dezinfekcijske naprave - 4. del: Zahteve in preskusi za čistilno-dezinfekcijske naprave s kemično dezinfekcijo za termolabilne endoskope (ISO 15883-4:2008)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-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 les laveurs désinfecteurs
destinés a la désinfection chimique des endoscopes thermolabiles (ISO 15883-4:2008)
Ta slovenski standard je istoveten z: EN ISO 15883-4:2008
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
May 2008
ICS 11.080.10
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 21 April 2008.
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: rue de Stassart, 36 B-1050 Brussels
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15883-4:2008: E
worldwide for CEN national Members.
Contents Page
Foreword.3
Annex ZA (informative) Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices .4
Foreword
This document (EN ISO 15883-4:2008) has been prepared by Technical Committee CEN/TC 102 “Sterilizers
for medical purposes”, the secretariat of which is held by DIN, in collaboration with Technical Committee
ISO/TC 198 "Sterilization of health care products ".
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 November 2008, and conflicting national standards shall be withdrawn
at the latest by November 2008.
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 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(s).
For relationship with EC Directive(s), see informative Annex ZA, B, C or D, 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.
Annex ZA
(informative)
Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices
By agreement between ISO and CEN, this CEN annex is included in the DIS and the FDIS but will not appear
in the published ISO standard.
This 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 International Standard and Directive 93/42/EEC on
medical devices
Clause(s)/sub-clause(s) of this
Essential Requirements (ERs) of Qualifying remarks/Notes
International Standard
Directive 93/42/EEC
4.1.1
1, 2, 3, 4, 5, 6, 7.1, 7.2, 7.3, 7.5, 7.6, The WD shall comply with the
8.1, 9.1, 9.2, 9.3, 12.1, 12.5, 12.6, requirements of ISO 15883-1:2006
12.7.1, 12.7.3, 12.7.5, 13.1, 13.3, 13.4,
13.6
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
7.3, 8.1
4.1.6
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)
Clause(s)/sub-clause(s) of this
Essential Requirements (ERs) of Qualifying remarks/Notes
International Standard
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.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of 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, manufacture and construction. 12
5.2 Device channel irrigation system. 12
5.3 Venting and drainage systems. 13
5.4 Temperature control. 14
5.5 Process chemicals. 14
5.6 Process verification. 14
5.7 Dosing systems . 14
6 Testing for conformity. 14
6.1 General. 14
6.2 Test equipment . 15
6.3 Water used for final (post-disinfection) rinsing. 15
6.4 Hardness of water used during type testing. 15
6.5 Leak test .
...
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