EN ISO 15883-6:2011
(Main)Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO 15883-6:2011)
Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO 15883-6:2011)
ISO 15883-6:2011 specifies particular requirements for washer-disinfectors (WDs) intended for use when the level of assurance of disinfection that is necessary can be achieved by cleaning and thermal disinfection (A0 not less than 60) and does not require an independent automated record of critical processes to be kept. It is intended to be used in conjunction with ISO 15883-1, which gives general requirements for WDs.
The range of products on which WDs of this particular type can be used is restricted to devices and equipment which are non-invasive and non-critical (i.e. not penetrating skin or contacting mucosal surfaces).
Reinigungs-Desinfektionsgeräte - Teil 6: Anforderungen und Prüfverfahren für Reinigungs-Desinfektionsgeräte mit thermischer Desinfektion für nicht invasive, nicht kritische Medizinprodukte und Zubehör im Gesundheitswesen (ISO 15883-6:2011)
Der vorliegende Teil der ISO 15883 legt besondere Anforderungen an Reinigungs-Desinfektionsgeräte (RDG)
fest, die zur Verwendung vorgesehen sind, wenn der erforderliche Desinfektionssicherheitsgrad durch Reinigung
und thermische Desinfektion (A0 nicht unter 60) erreicht werden kann und es nicht erforderlich ist, eine
unabhängige automatisierte Aufzeichnung kritischer Prozesse aufzubewahren. Er soll zusammen mit
ISO 15883-1, welche allgemeine Anforderungen an RGD festlegt, angewendet werden.
Der Produktbereich, an dem RDG dieses Typs angewendet werden können, ist auf Produkte und Zubehör
beschränkt, die nicht invasiv und nicht kritisch sind (die d. h. nicht die Haut durchdringen oder Kontakt mit den
Schleimhautoberflächen haben).
ANMERKUNG Die thermische Desinfektion kann durch Spülen der Beladung mit heißem Wasser, durch Einwirkung
von Dampf oder durch eine Kombination aus Beidem erreicht werden.
Laveurs désinfecteurs - Partie 6: Exigences et essais pour les laveurs désinfecteurs utilisant une désinfection thermique pour les dispositifs médicaux non invasifs, non critiques et pour l'équipement de soins de santé (ISO 15883-6:2011)
L'ISO 15883-6:2011 spécifie les exigences particulières des laveurs désinfecteurs destinés à être utilisés lorsque le niveau d'assurance de désinfection nécessaire peut être obtenu par nettoyage et désinfection thermique (A0 au moins égal à 60) et ne nécessite pas que soit conservé un enregistrement automatique indépendant des procédés critiques. Elle est destinée à être utilisée conjointement à l'ISO 15883-1, qui donne des exigences générales pour les laveurs désinfecteurs.
La gamme de produits sur lesquels les laveurs désinfecteurs de ce type particulier peuvent être utilisés est limitée aux dispositifs et équipements non invasifs et non critiques (c'est-à-dire qui ne traversent pas la peau et qui ne sont pas en contact avec les muqueuses).
Čistilno-dezinfekcijske naprave - 6. del: Zahteve in preskusi za čistilno-dezinfekcijske naprave s toplotno dezinfekcijo za neinvazivne, nenujne medicinske pripomočke in zdravstveno opremo (ISO 15883-6:2011)
Ta del ISO 15883 določa posebne zahteve za čistilno-dezinfekcijske naprave (WD), namenjene uporabi, kadar se stopnja zagotovitve dezinfekcije, ki je potrebna, lahko doseže s čiščenjem in toplotno dezinfekcijo (AO ni manjši od 60) in ne zahteva hranjenja neodvisnega avtomatiziranega zapisa kritičnih procesov. Namenjen je uporabi skupaj z ISO 15883-1, ki podaja splošne zahteve za WD. Razpon proizvodov, na katerih se lahko uporabijo WD-ji tega določenega tipa, je omejen na pripomočke in opremo, ki so neinvazivni in nekritični (tj. ne predirajo kože in niso v stiku s površinami sluznice).
OPOMBA: Toplotna dezinfekcija je lahko dosežena s povečevanjem tlaka z vročo vodo, izpostavljenostjo pari ali kombinacijo obeh.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2011
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GH]LQIHNFLMVNHQDSUDYHVWRSORWQRGH]LQIHNFLMR]DQHLQYD]LYQHQHQXMQHPHGLFLQVNH
SULSRPRþNHLQ]GUDYVWYHQRRSUHPR ,62
Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing
thermal disinfection for non-invasive, non-critical medical devices and healthcare
equipment (ISO 15883-6:2011)
Reinigungs-Desinfektionsgeräte - Teil 6: Anforderungen und Prüfverfahren von
Reinigungs-Desinfektionsgeräten mit thermischer Desinfektion für nichtinvasive, nicht
kritische Medizinprodukte und Zubehör im Gesundheitswesens (ISO 15883-6:2011)
Laveurs désinfecteurs - Partie 6: Exigences et essais pour les laveurs désinfecteurs
utilisant une désinfection thermale pour les dispositifs médicaux non invasifs, non
critiques et pour l'équipement de soins de santé (ISO 15883-6:2011)
Ta slovenski standard je istoveten z: EN ISO 15883-6:2011
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 15883-6
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2011
ICS 11.080.10
English Version
Washer-disinfectors - Part 6: Requirements and tests for
washer-disinfectors employing thermal disinfection for non-
invasive, non-critical medical devices and healthcare equipment
(ISO 15883-6:2011)
Laveurs désinfecteurs - Partie 6: Exigences et essais pour Reinigungs-Desinfektionsgeräte - Teil 6: Anforderungen
les laveurs désinfecteurs utilisant une désinfection
und Prüfverfahren für Reinigungs-Desinfektionsgeräte mit
thermique pour les dispositifs médicaux non invasifs, non thermischer Desinfektion für nicht invasive, nicht kritische
critiques et pour l'équipement de soins de santé (ISO Medizinprodukte und Zubehör im Gesundheitswesen (ISO
15883-6:2011) 15883-6:2011)
This European Standard was approved by CEN on 14 April 2011.
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, 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
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15883-6:2011: 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 .4
Foreword
This document (EN ISO 15883-6:2011) has been prepared by Technical Committee ISO/TC 198 "Sterilization
of health care products" in collaboration with 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 October 2011, and conflicting national standards shall be withdrawn at
the latest by October 2011.
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 EU Directive.
For relationship with EU 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, Croatia, 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 15883-6:2011 has been approved by CEN as a EN ISO 15883-6:2011 without any
modification.
Annex ZA
(informative)
Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42/EEC
This International 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 Union under that Directive and has been
implemented as a national standard in at least one Member State, 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.
Table ZA.1 — Correspondence between this International Standard and Directive 93/42/EEC
on medical devices
Clauses/subclauses of this Essential requirements (ERs)of EU
Qualifying remarks/Notes
International Standard Directive 93/42/EEC
This part shall comply also with the
1, 2, 3, 4, 5, 6, 7.1, 7.2, 7.3, 7.5, 7.6, 8.1,
requirements of EN ISO 15883-1 in
4.1.1 9.1, 9.2, 9.3, 12.1, 12.5, 12.6, 12.7.1,
which the essential requirements are
12.7.2, 12.7.3, 12.7.5, 13.1, 13.3, 13.4
covered
This relevant Essential Requirement is
4.1.1 13.3 a)
partly addressed in EN ISO 15883-1
4.1.2 1, 3, 4, 6, 7.1, 8.1, 9.1
4.1.3 1, 3, 4, 6, 7.1, 8.1, 9.1
4.1.5 7.3, 8.1
4.2 3, 8.1
4.3 3, 8.1
5.1 3, 8.1
5.2 3, 8.1
Testing for conformity according to
6.1 1, 2, 3, 4, 7.1, 8.1
ISO 15883-1
6.2 3, 8.1
6.3 3, 8.1
7 9.1, 13.6
8 1, 3, 7.1, 7.2, 8.1
This relevant Essential Requirement is
— 12.1a)
not addressed
This relevant Essential Requirement is
— 13.6 q)
not addressed
WARNING: Other requirements and other EU Directives 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, Table ZA.2 details the relevant essential
requirements of Directive 2006/42/EC to the extent to which they are more specific than those of Directive
93/42/EEC, along with the corresponding clauses of this International Standard. Table ZA.2, however, does
not imply any citation in the Official Journal of the European Communities under the machinery directive and
thus does not provide presumption of conformity with that 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)/subclause(s)
Requirements (EHSRs) of Qualifying remarks/Notes
of this EN
Directive 2006/42/EC
1.1.7, 1.2.2, 1.2.3, 1.2.4, 1.2.5, 1.3.2,
1.3.3, 1.3.4, 1.5.1, 1.5.2, 1.5.3, 1.5.5, These relevant Essential Requirements
4.1.1
1.5.6, 1.5.8, 1.5.13, 1.5.14, 1.6.2, 1.6.3, are addressed
1.6.4, 1.6.5
1.1.3, 1.1.5, 1.1.6, 1.2.1, 1.2.6, 1.3.1,
These relevant Essential Requirements
4.1.1 1.3.7, 1.3.8.1, 1.3.8.2, 1.5.4, 1.6.1, 1.7.1,
are partly addressed
1.7.2, 1.7.3, 1.7.4
These relevant Essential Requirements
— 1.3.9, 1.4.1, 1.4.2, 1.4.3, 1.5.9, 4
are not addressed
INTERNATIONAL ISO
STANDARD 15883-6
First edition
2011-04-15
Washer-disinfectors —
Part 6:
Requirements and tests for
washer-disinfectors employing thermal
disinfection for non-invasive, non-critical
medical devices and healthcare
equipment
Laveurs désinfecteurs —
Partie 6: Exigences et essais pour les laveurs désinfecteurs utilisant
une désinfection thermique pour les dispositifs médicaux non invasifs,
non critiques et pour l'équipement de soins de santé
Reference number
ISO 15883-6:2011(E)
©
ISO 2011
ISO 15883-6:2011(E)
© ISO 2011
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
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ISO 15883-6:2011(E)
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.1
3 Terms and definitions .2
4 Performance requirements.2
4.1 General .2
4.2 Cleaning .3
4.3 Disinfecting .3
5 Mechanical and control requirements.4
5.1 Control systems .4
5.2 Process verification .4
6 Testing for conformity .4
6.1 General .4
6.2 Tests for soil removal from chamber walls, load carrier and load.4
6.3 Thermometric tests .5
7 Information to be supplied by the manufacturer .5
8 Information to be requested from the purchaser by the supplier of the WD .5
Annex A (informative) Summary of test programmes.6
Bibliography.7
ISO 15883-6:2011(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft In
...
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