EN ISO 15883-4:2018
(Main)Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2018)
Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2018)
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.
This document also specifies the performance requirements for the cleaning and disinfection of the washer-disinfector and its components and accessories which can be required to achieve the necessary performance criteria.
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 requalification of WD periodically and after essential repairs, are also specified.
NOTE 1 In addition, Annex A gives guidance on an appropriate division of responsibility for the range of activities covered by this document.
NOTE 2 WD complying with this document can also be used for cleaning and chemical disinfection of other thermolabile re-usable medical devices for which the device manufacturer has recommended and validated this method of disinfection.
WD complying with the requirements of this document are not intended for cleaning and disinfection of medical devices, including endoscopic accessories, which are heat stable and can be disinfected or sterilized by thermal methods (see ISO 15883-1:2006+Amd 1:2014, 4.1.5).
The specified performance requirements of this document do not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.
NOTE 3 If it is considered that prion protein might be present, particular care is needed in the choice of cleaning agents and disinfectants to ensure that the chemicals used do not react with the prion protein and/or other protein in a manner that can inhibit its removal or inactivation from the load or washer-disinfector.
NOTE 4 This document can be used by prospective purchasers and manufacturers as the basis of agreement on the specification of the WD, manufacturers of endoscopes, cleaning products, and disinfecting products.
Reinigungs-Desinfektionsgeräte - Teil 4: Anforderungen und Prüfverfahren für Reinigungs-Desinfektionsgeräte mit chemischer Desinfektion für thermolabile Endoskope (ISO 15883-4:2018)
Dieses Dokument legt die besonderen Anforderungen, einschließlich der Leistungskriterien, an Reinigungs Desinfektionsgeräte (RDG) fest, die für das Reinigen und die chemische Desinfektion von thermolabilen Endoskopen vorgesehen sind.
Dieses Dokument legt außerdem die Leistungsanforderungen an die Reinigung und die Desinfektion des Reinigungs Desinfektionsgeräts sowie von dessen Bauteilen und Zubehör fest, die zum Erreichen der erforderlichen Leistungskriterien erforderlich sein können.
Des Weiteren sind die Verfahren, Ausrüstungen und Anweisungen festgelegt, die für die Typprüfung, Werksprüfung, Validierung (Installations , Funktions und Leistungsqualifizierung nach erstmaliger Installation), Routinekontrolle und Überwachung sowie die regelmäßig und nach größeren Reparaturen durchzuführende Requalifizierung von RDG erforderlich sind.
ANMERKUNG 1 Zusätzlich gibt Anhang A einen Leitfaden für eine geeignete Aufteilung der Verantwortlichkeiten für die in diesem Dokument erfassten Tätigkeiten.
ANMERKUNG 2 RDG, die diesem Dokument entsprechen, können auch zur Reinigung und zur chemischen Desinfektion von anderen thermolabilen und wiederverwendbaren Medizinprodukten verwendet werden, bei denen der Hersteller dieser Geräte dieses Desinfektionsverfahren empfohlen und validiert hat.
RDG, die den Anforderungen dieses Dokuments entsprechen, sind nicht zum Reinigen und Desinfizieren von Medizinprodukten, einschließlich endoskopischen Zubehörs, vorgesehen, die hitzebeständig sind und durch thermische Verfahren (siehe ISO 15883 1:2006 + Amd 1:2014, 4.1.5) desinfiziert oder sterilisiert werden können.
Die in diesem Dokument festgelegten Leistungsanforderungen stellen nicht die Inaktivierung oder die Entfernung des (der) verursachenden Agens (Agenzien) (Prionenprotein) von übertragbaren spongiformen Enzephalopathien sicher.
ANMERKUNG 3 Sofern berücksichtigt wird, dass Prionenprotein vorhanden sein könnten, ist bei der Wahl der Reinigungs und Desinfektionsmittel besondere Sorgfalt erforderlich, um sicherzustellen, dass die verwendeten Chemikalien nicht mit dem Prionenprotein und/oder anderen Proteinen auf eine Weise reagieren, die deren Entfernung oder Inaktivierung aus der Beladung oder dem Reinigungs Desinfektionsgerät verhindern kann.
ANMERKUNG 4 Dieses Dokument kann von potenziellen Käufern und Herstellern als Vertragsgrundlage zur Spezifikation des RDG, für Hersteller von Endoskopen sowie für Hersteller von Reinigungs und Desinfektionsprodukten verwendet werden.
Laveurs désinfecteurs - Partie 4: Exigences et essais pour les laveurs désinfecteurs destinés à la désinfection chimique des endoscopes thermolabiles (ISO 15883-4:2018)
Le présent document spécifie les exigences particulières, notamment les critères de performance, relatives aux laveurs désinfecteurs (LD) destinés à être utilisés pour le nettoyage et la désinfection chimique des endoscopes thermolabiles.
Le présent document 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 critères de performance requis.
Les méthodes, l'instrumentation et les instructions nécessaires pour les essais de type, de fonctionnement, la validation (qualification de l'installation, opérationnelle et des performances lors de la première installation), le contrôle de routine, la surveillance et la requalification des LD réalisés périodiquement et à la suite de réparations majeures sont également spécifiées.
NOTE 1 En outre, l'Annexe A donne des recommandations relatives à un partage approprié des responsabilités en ce qui concerne les différentes activités traitées par le présent document.
NOTE 2 Les LD conformes au présent document peuvent également être utilisés pour le nettoyage et la désinfection chimique d'autres dispositifs médicaux thermolabiles réutilisables pour lesquels le fabricant a recommandé et validé cette méthode de désinfection.
Les LD conformes aux exigences du présent document ne sont pas destinés à être utilisés pour le nettoyage et la désinfection des dispositifs médicaux, y compris les accessoires des endoscopes, qui sont thermostables et qui peuvent être désinfectés ou stérilisés par des méthodes thermiques (voir l'ISO 15883‑1:2006+Amd 1:2014, 4.1.5).
Les exigences de performance spécifiées dans le présent document ne permettent pas de garantir l'inactivation ou l'élimination du ou des agents pathogènes (protéine du prion) à l'origine des encéphalopathies spongiformes transmissibles.
NOTE 3 En cas de suspicion d'une possible présence de la protéine de prion sur la charge à traiter, une attention particulière est requise pour le choix des désinfectants et des détergents à employer afin de s'assurer que les produits chimiques utilisés ne réagissent pas avec la protéine du prion et/ou toute autre protéine d'une manière susceptible d'inhiber son inactivation ou son élimination de la charge ou du laveur désinfecteur.
NOTE 4 Le présent document peut être utilisé par des fabricants ou des acheteurs potentiels comme une base d'accord entre les spécifications des fabricants de LD, d'endoscopes, de produits de nettoyage et de produits désinfectants.
Čistilno-dezinfekcijske naprave - 4. del: Zahteve in preskusi za čistilno-dezinfekcijske naprave s kemično dezinfekcijo za termolabilne endoskope (ISO 15883-4:2018)
Ta dokument določa posebne zahteve, vključno s kriteriji učinkovitosti, za čistilno-dezinfekcijske naprave (WD), ki so namenjene za čiščenje in kemično dezinfekcijo termolabilnih endoskopov.
Ta dokument določa tudi zahteve za učinkovitost čiščenja in dezinfekcije čistilno-dezinfekcijske naprave in njenih sestavnih delov ter dodatkov, ki jih je mogoče zahtevati za dosego želenih kriterijev učinkovitosti.
Določene so tudi metode, instrumenti in navodila, ki so potrebni za preskušanje tipa, delovanja, validacijo (namestitev, operativno in delovno ustreznost ob prvi namestitvi), rutinsko kontrolo in nadzor ter ponovno potrditev ustreznosti čistilno-dezinfekcijske naprave v intervalih ter po nujnih popravilih.
OPOMBA 1: V dodatku A so tudi smernice o ustrezni delitvi odgovornosti za vrsto dejavnosti, ki jih zajema ta dokument.
OPOMBA 2: Čistilno-dezinfekcijsko napravo, ki je v skladu s tem dokumentom, je mogoče uporabljati tudi za čiščenje in kemično dezinfekcijo drugih termolabilnih medicinskih pripomočkov, ki jih je mogoče ponovno uporabiti, za katere je proizvajalec pripomočka priporočil in potrdil to metodo dezinfekcije.
Čistilno-dezinfekcijska naprava, ki izpolnjuje zahteve tega dokumenta, ni namenjena za čiščenje in dezinfekcijo medicinskih pripomočkov, vključno z endoskopskimi pripomočki, ki so toplotno stabilni in jih je mogoče dezinficirati ali sterilizirati s toplotnimi metodami (glej ISO 15883-1:2006+Amd 1:2014, 4.1.5).
Določene zahteve glede učinkovitosti v tem dokumentu ne zagotavljajo inaktivacije ali odstranitve
povzročiteljev (prionski protein) transmisivnih spongiformnih encefalopatij.
OPOMBA 3: Če obstaja sum, da je prisoten prionski protein, je potrebno posebej skrbno izbrati čistilna sredstva in razkužila, da se zagotovi, da uporabljene kemikalije ne reagirajo s prionskim proteinom in/ali drugimi proteini na način, ki bi morda zaviral njegovo odstranitev ali inaktivacijo v čistilno-dezinfekcijski napravi ali na njeni naloženi vsebini.
OPOMBA 4: Ta dokument lahko uporabljajo bodoči kupci in proizvajalci kot podlago za dogovor o specifikaciji za čistilno-dezinfekcijske naprave, proizvajalce endoskopov, čistilnih sredstvev in dezinfekcijskih izdelkov.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2019
1DGRPHãþD
SIST EN ISO 15883-4:2009
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 15883-4:2018)
Reinigungs-Desinfektionsgeräte - Teil 4: Anforderungen und Prüfverfahren für
Reinigungs-Desinfektionsgeräte mit chemischer Desinfektion für thermolabile Endoskope
(ISO 15883-4:2018)
Laveurs désinfecteurs - Partie 4: Exigences et essais pour les laveurs désinfecteurs
destinés à la désinfection chimique des endoscopes thermolabiles (ISO 15883-4:2018)
Ta slovenski standard je istoveten z: EN ISO 15883-4:2018
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 15883-4
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2018
EUROPÄISCHE NORM
ICS 11.080.10 Supersedes EN ISO 15883-4:2009
English Version
Washer-disinfectors - Part 4: Requirements and tests for
washer-disinfectors employing chemical disinfection for
thermolabile endoscopes (ISO 15883-4:2018)
Laveurs désinfecteurs - Partie 4: Exigences et essais Reinigungs-Desinfektionsgeräte - Teil 4:
pour les laveurs désinfecteurs destinés à la Anforderungen und Prüfverfahren für Reinigungs-
désinfection chimique des endoscopes thermolabiles Desinfektionsgeräte mit chemischer Desinfektion für
(ISO 15883-4:2018) thermolabile Endoskope (ISO 15883-4:2018)
This European Standard was approved by CEN on 17 August 2018.
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-CENELEC 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-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15883-4:2018 E
worldwide for CEN national Members.
Contents
Page
European foreword .3
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered .5
European foreword
This document (EN ISO 15883-4:2018) has been prepared by Technical Committee ISO/TC 198 "Sterilization
of health care products" in collaboration with Technical Committee CEN/TC 102 “Sterilizers and associated
equipment for processing of medical devices” 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 June 2019, and conflicting national standards shall be withdrawn at
the latest by June 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 15883-4:2009.
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 EU Directive(s).
For relationship with EU Directive(s), 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, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
The following referenced documents are indispensable for the application of this document. For undated
references, the latest edition of the referenced document (including any amendments) applies. For dated
references, only the edition cited applies. However, for any use of this standard ‘within the meaning of Annex
ZA’, the user should always check that any referenced document has not been superseded and that its
relevant contents can still be considered the generally acknowledged state-of-art.
When an IEC or ISO standard is referred to in the ISO standard text, this should be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version of the
ISO or IEC standard as listed below.
NOTE The way in which these referenced documents are cited in normative requirements determines the extent (in
whole or in part) to which they apply.
Table – Correlation between normative references and dated EN and ISO standards
Normative references Equivalent dated standard
as listed in Clause 2 of the ISO
standard
EN ISO
ISO 14971 EN ISO 14971:2012 ISO 14971:2007
ISO 15883-1 EN ISO 15883-1:2009 + A1:2014 ISO 15883-1:2006 + Amd1:2014
ISO/TS 15883-5 CEN/ISO/TS 15883-5:2005 ISO TS 15883-5:2005
IEC 61010-2-040 EN 61010-2-040:2015 IEC 61010-2-040:2015
Normative references Equivalent dated standard
as listed in Clause 2 of the ISO
standard
EN ISO
EN 12353 EN 12353:2013 --
EN 13727 EN 13727:2013+A2:2015 --
Endorsement notice
The text of ISO 15883-4:2018 has been approved by CEN as EN ISO 15883-4:2018 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered
This European Standard has been prepared under a Commission’s mandate M/023 concerning the
development of European Standards related to medical devices to provide one voluntary means of conforming
to essential requirements of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices [OJ L
169].
Once this standard is cited in the Official Journal of the European Union under that Directive, compliance with
the normative 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.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This means that
risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’ or ‘removed’,
according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential Requirements
1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZA.1 — Correspondence between this European Standard and Annex I of
Directive 93/42/EEC [OJ L 169]
Clause(s)/sub-clause(s) of this Remarks/Notes
Essential
EN
Requirements of
Directive 93/42/EEC
st
7.3, 1 part only 4.9.2 Covered only in respect of
disinfection of the incoming
water treatment equipment.
Aspects related to manufacturing
are not covered
7.6 4.6.2, 4.9.2.3 Standard clause 4.6.2 covers ER
7.6 for the ingress of oil and
particles, standard clause
4.9.2.3 for the ingress of
microbes into the endoscopes
being processed only. Aspects
related to manufacturing are not
covered.
Clause(s)/sub-clause(s) of this Remarks/Notes
Essential
EN
Requirements of
Directive 93/42/EEC
8.1 4.1.2, 4.1.3, 4.1.5, 4.1.6, 4.1.7, Covered only in respect of
4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8,
preventing patient and user
4.9, 5.2, 5.3, 5.4, 5.5
infection by the effective
reprocessing of endoscopes.
Aspects related to manufacturing
are not covered.
The last sentence of ER 8.1 is
not covered.
9.1 4.1.2, 4.1.3, 4.1.7, 4.1.8, 4.2.4,
Covered only in respect of
4.8, 4.9, 5.1, 5.2
preventing patient cross infection
by the effective reprocessing of
endoscopes.
The last sentence of ER 9.1 is
not covered.
13.6 a) 8 k) Covered for the information
required in ER 13.3 j)
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European Standard
is maintained in the list published in the Official Journal of the European Union. Users of this standard should
consult frequently the latest list published in the Official Journal of the European Union.
WARNING 2 — Other Union legislation may be applicable to the products 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)
Essential Health and Safety Clause(s)/sub-clause(s) of this Remarks/Notes
Requirements (EHSRs) of EN
Directive 2006/42/EC
nd
1.2.1, 2 dash 4.2.3, 4.2.4, 4.4.4, 4.8.4 Covered in respect of leak
detection and process
monitoring during endoscope
processing and self-disinfection
procedure.
Essential Health and Safety Clause(s)/sub-clause(s) of this Remarks/Notes
Requirements (EHSRs) of EN
Directive 2006/42/EC
1.5.4 4.1.8, 4.2.4 a), 4.2.4 b), 8
Standard clause 4.1.8 and
4.2.4a), 4.2.4 b) cover EHSR
1.5.4 in respect of connections
for process chemicals and
connection systems between the
WD and the endoscope only.
Standard clause 8 covers EHSR
1.5.4 second paragraph only.
1.6.5 4.8, 4.9 Standard clause 4.8 covers
EHSR 1.6.5 with respect to
requiring a self-disinfection
cycle, clause 4.9 to requiring a
procedure for disinfection of the
water treatment equipment to be
provided.
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European Standard
is maintained in the list published in the Official Journal of the European Union. Users of this standard should
consult frequently the latest list published in the Official Journal of the European Union.
WARNING 2 — Other Union legislation may be applicable to the products falling within the scope of this
standard.
INTERNATIONAL ISO
STANDARD 15883-4
Second edition
2018-11
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 15883-4:2018(E)
©
ISO 2018
ISO 15883-4:2018(E)
© ISO 2018
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ISO 15883-4:2018(E)
Contents Page
Foreword .vi
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