EN ISO 15883-6:2015

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 čistilno-dezinfekcijskih naprav s toplotno dezinfekcijo za neinvazivne, nenujne medicinske pripomočke in zdravstveno opremo (ISO 15883-6:2011)

Standard ISO 15883-6:2011 določa posebne zahteve za čistilno-dezinfekcijske naprave (WD), ki so namenjene uporabi, ko je potrebno raven zagotavljanja dezinfekcije mogoče zagotoviti s čiščenjem in toplotno dezinfekcijo (A0 ne manj kot 60) ter ni potrebno neodvisno avtomatizirano shranjevanje kritičnih procesov. Standard je treba uporabljati v povezavi s standardom ISO 15883-1, ki določa splošne zahteve za čistilno-dezinfekcijske naprave.
Nabor izdelkov, pri katerih je mogoče uporabiti čistilno-dezinfekcijske naprave tega tipa, je omejen na neinvazivne in nenujne medicinske pripomočke ter zdravstveno opremo (tj. ne prodirajo skozi kožo ali se dotikajo sluznic).

General Information

• Status: Published
• Publication Date: 18-Aug-2015
• Withdrawal Date: 28-Feb-2016
• 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: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 19-Aug-2015
• Completion Date: 19-Aug-2015
• 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 15883-6:2015 - 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)

Relations

• Replaces: EN 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)
• Effective Date: 12-Aug-2015

Standards Content (Sample)

SLOVENSKI STANDARD
01-oktober-2015
1DGRPHãþD
SIST EN ISO 15883-6:2011
ýLVWLOQRGH]LQIHNFLMVNHQDSUDYHGHO=DKWHYHLQSUHVNXVLþLVWLOQR
GH]LQIHNFLMVNLKQDSUDYVWRSORWQRGH]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 für
Reinigungs-Desinfektionsgeräte mit thermischer Desinfektion für nicht invasive, nicht
kritische Medizinprodukte und Zubehör im Gesundheitswesen (ISO 15883-6:2011)
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)
Ta slovenski standard je istoveten z: EN ISO 15883-6:2015
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
August 2015
ICS 11.080.10 Supersedes EN ISO 15883-6:2011
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 4 August 2015.

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, 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: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15883-6:2015 E
worldwide for CEN national Members.

Contents Page
European foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices .5
European foreword
This document (EN ISO 15883-6:2015) has been prepared by Technical Committee ISO/TC 198 “Sterilization
of healthcare products” in collaboration with 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 February 2016, and conflicting national standards shall be withdrawn
at the latest by February 2016.
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 15883-6:2011.
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.
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
EN ISO
standard
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

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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 15883-6:2011 has been approved by CEN as EN ISO 15883-6:2015 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices
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 the Essential Requirements of
the 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.
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 Directive 93/42/EEC
on medical devices
Clauses/subclauses of this Essential requirements (ERs) Qualifying remarks/Notes
European Standard of EU Directive 93/42/EEC
9 7.2 In addition requirements of EN
ISO 15883-1 apply.
4.1.1,8 7.2 This part shall comply also with the
requirements of EN ISO 15883-1 in
which the essential requirements
are covered
4.1.1, 4.1.5 7.3 This part shall comply also with the
requirements of EN ISO 15883-1 in
which the essential requirements
are covered
4.1.1 7.5 This part shall comply also with the
requirements of EN ISO 15883-1 in
which the essential requirements
are covered
4.1.1 7.6 This part shall comply also with the
requirements of EN ISO 15883-1 in
which the essential requirements
Clauses/subclauses of this Essential requirements (ERs) Qualifying remarks/Notes
European Standard of EU Directive 93/42/EEC
are covered
4.1.1 8.1 This part shall comply also with the
requirements of EN ISO 15883-1 in
which the essential requirements
are covered
4.1.2, 4.1.3, 4.1.5, 4.2, 4.3, 8.1
5.1, 5.2, 6.2, 6.3, 8
6.1 8.1 Testing for conformity according to
EN ISO 15883-1
4.1.1 9.1 This part shall comply also with the
requirements of EN ISO 15883-1 in
which the essential requirements
are covered
4.1.2, 4.1.3, 7 9.1
4.1.1 9.2, 9.3 This part shall comply also with the
requirements of EN ISO 15883-1 in
which the essential requirements
are covered
4.1.1 12.1 This part shall comply also with the
requirements of EN ISO 15883-1 in
which the essential requirements
are covered
4.1.1 12.5 This part shall comply also with the
requirements of EN ISO 15883-1 in
which the essential requirements
are covered
4.1.1 12.6 This part shall comply also with the
requirements of EN ISO 15883-1 in
which the essential requirements
are covered
4.1.1 12.7.1 This part shall comply also with the
requirements of EN ISO 15883-1 in
which the essential requirements
are covered
4.1.1 12.7.2 This part shall comply also with the
requirements of EN ISO 15883-1 in
which the essential requirements
are covered
4.1.1 12.7.3 This part shall comply also with the
requirements of EN ISO 15883-1 in
which the essential requirements
are covered
4.1.1 12.7.5 This part shall comply also with the
requirements of EN ISO 15883-1 in
which the essential requirements
are covered
Clauses/subclauses of this Essential requirements (ERs) Qualifying remarks/Notes
European Standard of EU Directive 93/42/EEC
4.1.1 13.1 This part shall comply also with the
requirements of EN ISO 15883-1 in
which the essential requirements
are covered
4.1.1 13.3 This part shall comply also with the
requirements of EN ISO 15883-1 in
which the essential requirements
are covered
4.1.1 13.4 This part shall comply also with the
requirements of EN ISO 15883-1 in
which the essential requirements
are covered
4.1.1 13.3 a) This relevant Essential
Requirement is partly addressed in
EN ISO 15883-1
7 13.6
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
European Standard Requirements (EHSRs) of
Directive 2006/42/EC
4.1.1 1
4.1.1 1.1.3 See in addition
EN ISO 15883-1:2009+A1:2014,
5.1.1, 5.1.2, 5.2 and 5.3.2 a)
4.1.1 1.1.5 See in addition EN
ISO 15883-1:2009+A1:2014, 9.2
4.1.1 1.1.6 See in addition EN
ISO 15883-1:2009+A1:2014,
5.12.3, 5.27.1 and 6.6.2
4.1.1 1.1.7 See in addition EN
ISO 15883-1:2009+A1:2014, 5.2
st nd
4.1.1 1.2.1, 1 and 2 dash See in addition EN
ISO 15883-1:2009+A1:2014,
5.2.2, 5.2.4, 5.12.1, 5.20 and 5.22
Clause(s)/sub-clause(s) of this Essential Health and Safety Qualifying remarks/Notes
European Standard Requirements (EHSRs) of
Directive 2006/42/EC
st
4.1.1 1.2.2, 1 dash See in addition EN
ISO 15883-1:2009+A1:2014, 5.2,
5.12.3, 5.12.8 and 5.12.9
4.1.1 1.2.3 See in addition EN
ISO 15883-1:2009+A1:2014,
5.2.1
4.1.1 1.2.4
4.1.1 1.2.5 See in addition EN
ISO 15883-1:2009+A1:2014, 5.18
and 5.19
4.1.1 1.2.6 See in addition EN
ISO 15883-1:2009+A1:2014, 5.2
and 5.4.1.9
4.1.1 1.3.1 See in addition EN
ISO 15883-1:2009+A1:2014,
5.2.1
Including reference to EN 61010-
2-040:2005, 7.3
4.1.1 1.3.2 See in addition EN
ISO 15883-1:2009+A1:2014, 5.1,
5.2.1 and 8.3 g)
4.1.1 1.3.3 See in addition EN
ISO 15883-1:2009+A1:2014,
5.2.1
4.1.1 1.3.4 See in addition EN
ISO 15883-1:2009+A1:2014,
5.1.6 and 5.2.1
Including reference to EN 61010-
2-040:2005, clause 7
4.1.1 1.3.7 See in addition EN
IS
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