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SIST EN ISO 15883-6:2015

(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 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
15-Sep-2015
ICS
11.080.10 - Sterilizing equipment
Technical Committee
VAZ - Healthcare
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
27-Aug-2015
Due Date
01-Nov-2015
Completion Date
16-Sep-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
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
SIST 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
01-Oct-2015
Replaces
SIST 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
08-Jun-2022

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 15883-6:2015
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
SIST EN ISO 15883-6:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 15883-6:2015

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SIST EN ISO 15883-6:2015

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.

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SIST EN ISO 15883-6:2015
EN ISO 15883-6:2015 (E)
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
2

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SIST EN ISO 15883-6:2015
EN ISO 15883-6:2015 (E)
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.
3

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SIST EN ISO 15883-6:2015
EN ISO 15883-6:2015 (E)
Endorsement notice
The text of ISO 15883-6:2011 has been approved by CEN as EN ISO 15883-6:2015 without any modification.
4

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SIST EN ISO 15883-6:2015
EN ISO 15883-6:2015 (E)
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
5

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SIST EN ISO 15883-6:2015
EN ISO 15883-6:2015 (E)
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
6

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SIST EN ISO 15883-6:2015
EN ISO 15883-6:2015 (E)
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
7

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SIST EN ISO 15883-6:2015
EN ISO 15883-6:2015 (E)
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
ISO 15883-1:2009+A1:2014,
5.2.1
4.1.1 1.3.8 See in addition EN
ISO 15883-1:2009+A1:2014,
5.2.1
4.1.1 1.5.1 See in addition EN
ISO 15883-1:2009+A1:2014,
5.2.1
4.1.1 1.5.2 See in addition EN
ISO 15883-1:2009+A1:2014,
5.2.1
4.1.1 1.5.3 See in addition EN
ISO 15883-1:2009+A1:2014,
5.2.1
4.1.1 1.5.4 See in addition EN
ISO 15883-1:2009+A1:2014,
8

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SIST EN ISO 15883-6:2015
EN ISO 15883-6:2015 (E)
Clause(s)/sub-clause(s) of this Essential Health and Safety Qualifying remarks/Notes
European Standard Requirements (EHSRs) of
Directive 2006/42/EC
5.2.1 and 8.3
4.1.1 1.5.5 See in addition EN
ISO 15883-1:2009+A1:2014,
5.2.1
4.1.1 1.5.6 See in addition EN
ISO 15883-1:2009+A1:2014,
5.2.1 and 5.8
4.1.1 1.5.8 See in addition EN
ISO 15883-1:2009+A1:2014,
5.2.1
4.1.1 1.5.13 See in addition EN
ISO 15883-1:2009+A1:2014,
5.2.1 and 8.1 b)
Including reference to EN 61010-
2-040:2005, clause 11
4.1.1 1.5.14 See in addition EN
ISO 15883-1:2009+A1:2014,
5.2.1
Including reference to EN 61010-
2-040:2005, clause 15
4.1.1 1.6.1 See in addition EN
ISO 15883-1:2009+A1:2014,
5.1.5 and 5.2.1
4.1.1 1.6.2 See in addition EN
ISO 15883-1:2009+A1:2014,
5.1.5 and 5.2.1
4.1.1 1.6.3 See in addition EN
ISO 15883-1:2009+A1:2014,
5.2.1 and 8.2 a) and b)
4.1.1 1.6.4 See in addition EN
ISO 15883-1:2009+A1:2014,
5.2.1 and 5.4.1.6
4.1.1 1.6.5 See in addition EN
ISO 15883-1:2009+A1:2014,
4.2.1.1 and 5.1.10
4.1.1 1.7.1 See in addition EN
ISO 15883-1:2009+A1:2014,
5.2.1, 5.10.2, 5.10.3 and 5.20 h)
4.1.1 1.7.2 See in addition EN
ISO 15883-1:2009+A1:2014,
5.2.1 and 8 f)
4.1.1 1.7.3 See in addition EN
ISO 15883-1:2009+A1:2014,
5.2.1 and 9.1
4.1.1 1.7.4 See in addition EN
ISO 15883-1:2009+A1:2014,
9

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SIST EN ISO 15883-6:2015
EN ISO 15883-6:2015 (E)
Clause(s)/sub-clause(s) of this Essential Health and Safety Qualifying remarks/Notes
European Standard Requirements (EHSRs) of
Directive 2006/42/EC
Clause 7 and Clause 8
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.

10

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SIST EN ISO 15883-6:2015

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

---------------------- Page: 13 ----------------------

SIST EN ISO 15883-6:2015
ISO 15883-6:2011(E)

COPYRIGHT PROTECTED DOCUMENT


© 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,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland

ii © ISO 2011 – All rights reserved

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SIST EN ISO 15883-6:2015
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 .
...

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Large steam sterilizers can also be used during the commercial production of medical devices.
This European Standard does not specify requirements for equipment intended to use, contain or be exposed to flammable substances or substances which could cause combustion. This European Standard does not specify requirements for equipment intended to process biological waste or human tissues.
This European Standard does not describe a quality management system for the control of all stages of the manufacture of the sterilizer.
NOTE 1   Attention is drawn to the standards for quality management systems e.g. EN ISO 13485.
NOTE 2   Environmental aspects are addressed in Annex A.

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SIST EN ISO 15883-5:2021(Main)
Washer-disinfectors - Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy (ISO 15883-5:2021)
EN ISO 15883-5:2021

This document specifies procedures and test methods used to demonstrate the cleaning efficacy of
washer-disinfectors (WD) and their accessories intended to be used for cleaning of reusable medical
devices.
NOTE 1 The requirements can be used for washer-disinfectors intended for use with other articles used in the
context of medical, dental, laboratory, pharmaceutical and veterinary practice.
NOTE 2 This document does not apply to the activities to be performed by the manufacturers of reusable
medical devices.

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SIST EN ISO 15883-4:2019(Main)
Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2018)
EN ISO 15883-4:2018

This document specifies the particular requirements, including performance criteria for washerdisinfectors
(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.

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SIST EN 13060:2015+A1:2019(Main)
Small steam sterilizers
EN 13060:2014+A1:2018

This European Standard specifies the performance requirements and test methods for small steam sterilizers and sterilization cycles which are used for medical purposes or for materials that are likely to come into contact with blood or body fluids.
This European Standard applies to automatically controlled small steam sterilizers that generate steam using electrical heaters or use steam that is generated by a system external to the sterilizer.
This European Standard applies to small steam sterilizers used primarily for the sterilization of medical devices with a chamber volume of less than 60 l and unable to accommodate a sterilization module (300 mm × 300 mm × 600 mm).
The requirements concerning the quality management and risk management are addressed by other standards (e.g. EN ISO 13485, EN ISO 14971).
This European Standard does not apply to small steam sterilizers that are used to sterilize liquids or pharmaceutical products.
This European Standard does not specify safety requirements related to risks associated with the zone in which the sterilizer is used (e.g. flammable gases).
This European Standard does not specify requirements for the validation and routine control of sterilization by moist heat.
NOTE Requirements for the validation and routine control of sterilization by moist heat are given in EN ISO 17665-1.
This European Standard does not specify requirements for other sterilization processes that also employ moist heat as part of the process (i.e. formaldehyde, ethylene oxide).

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SIST EN ISO 15883-7:2016(Main)
Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (ISO 15883-7:2016)
EN ISO 15883-7:2016

This part of ISO 15883 specifies the particular requirements for washer-disinfectors (WD) intended to be used for the cleaning and chemical disinfection, in a single operating cycle, of re-usable items such as:
a) bedframes;
b) bedside tables;
c) transport carts;
d) containers;
e) surgical tables;
f) sterilization containers;
g) surgical clogs;
h) wheelchairs, aids for the disabled.
This Part of ISO 15883 also specifies the performance requirements for the cleaning and disinfection of the washer-disinfector and its components and accessories which may be necessary in order to achieve the required performance.
Devices identified within the Scopes of ISO 15883-2:2006, ISO 15883-3:2006, ISO I5883-4:2008, and ISO 15883-6:2011 do not fall within the scope of this part of ISO 15883.
In addition, the methods are specified as well as instrumentation and instructions required for type testing, works testing, validation (installation, operation, and performance qualification on first installation), routine control and monitoring as well as re-validations required to be carried out periodically and after essential repairs.
NOTE WDs corresponding to this part of ISO 15883 can also be used for cleaning and chemical disinfection of other thermolabile and re-usable medical devices as recommended by the device manufacturer.
The performance requirements specified in this part of ISO 15883 may not ensure the inactivation or removal of the causative agent(s) (prion proteins) of Transmissible Spongiform Encephalopathies.

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SIST EN 1422:2014(Main)
Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
EN 1422:2014

EN 1422 specifies the requirements and the relevant tests for automatically controlled sterilizers employing ethylene oxide (EO) gas as the sterilant, either as a pure gas or a mixture with other gases, being used for the sterilization of medical devices and their accessories. This European Standard specifies requirements for ethylene oxide sterilizers (EO-sterilizers) working at super or sub-atmospheric pressure for: - the performance and design of sterilizers to ensure that the process is capable of sterilizing medical devices; - the equipment and controls of these sterilizers necessary for the validation and routine control of the sterilization processes. The test loads described in this European Standard are selected to represent a number of loads for the evaluation of the performance of EO sterilizers for medical devices. However, specific loads may require the use of other test loads.

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SIST EN 14180:2014(Main)
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
EN 14180:2014

EN 14180 specifies requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only. These sterilizers are primarily used for the sterilization of heat labile medical devices in health care facilities. This European Standard specifies minimum requirements: - for the performance and design of sterilizers to ensure that the process is capable of sterilizing medical devices; - for the equipment and controls of these sterilizers necessary for the validation and routine control of the sterilization processes.

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SIST EN ISO 15883-1:2009/A1:2014(Amendment)
Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006/Amd 1: 2014)
EN ISO 15883-1:2009/A1:2014

This part of ISO 15883 specifies general performance requirements for washer-disinfectors (WD) and their accessories that are intended to be used for cleaning and disinfection of re-usable medical devices and other articles used in the context of medical, dental, pharmaceutical and veterinary practice. It specifies performance requirements for cleaning and disinfection as well as for the accessories which can be required to achieve the necessary performance. The methods and instrumentation required for validation, routine control and monitoring and re-validation, periodically and after essential repairs, are also specified. The requirements for washer-disinfectors intended to process specific loads are specified in subsequent parts of this standard. For washer-disinfectors intended to process loads of two or more different types the requirements of all relevant parts of this standard apply. This part of ISO 15883 does not specify requirements intended for machines for use for laundry or general catering purposes. This part of ISO 15883 does not include requirements for machines which are intended to sterilize the load, or which are designated as "sterilizers", these are specified in other standards e.g. EN 285. The specified performance requirements of this standard may not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies. This part of ISO 15883 may be used by prospective purchasers and manufacturers as the basis of agreement on the specification of a WD. The test methods for demonstration of compliance with the requirements of this part of ISO 15883 may also be employed by users to demonstrate continued compliance of the installed WD throughout its working life. Guidance on a routine test programme is given in Annex A.

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SIST EN ISO 15883-1:2009(Main)
Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006)
EN ISO 15883-1:2009

This part of ISO 15883 specifies general performance requirements for washer-disinfectors (WD) and their accessories that are intended to be used for cleaning and disinfection of re-usable medical devices and other articles used in the context of medical, dental, pharmaceutical and veterinary practice. It specifies performance requirements for cleaning and disinfection as well as for the accessories which can be required to achieve the necessary performance. The methods and instrumentation required for validation, routine control and monitoring and re-validation, periodically and after essential repairs, are also specified. The requirements for washer-disinfectors intended to process specific loads are specified in subsequent parts of this standard. For washer-disinfectors intended to process loads of two or more different types the requirements of all relevant parts of this standard apply. This part of ISO 15883 does not specify requirements intended for machines for use for laundry or general catering purposes. This part of ISO 15883 does not include requirements for machines which are intended to sterilize the load, or which are designated as "sterilizers", these are specified in other standards e.g. EN 285. The specified performance requirements of this standard may not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies. This part of ISO 15883 may be used by prospective purchasers and manufacturers as the basis of agreement on the specification of a WD. The test methods for demonstration of compliance with the requirements of this part of ISO 15883 may also be employed by users to demonstrate continued compliance of the installed WD throughout its working life. Guidance on a routine test programme is given in Annex A.

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SIST EN ISO 15883-3:2009(Main)
Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006)
EN ISO 15883-3:2009

This part of ISO 15883 specifies particular requirements for washer-disinfectors (WD) that are intended to be used for emptying, flushing, cleaning and thermal disinfection of containers used to hold human waste for disposal by one operating cycle. This part of ISO 15883 is to be applied in conjunction with ISO 15883-1.

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