EN ISO 15883-7:2016

SLOVENSKI STANDARD
01-maj-2016
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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)
Reinigungs-Desinfektionsgeräte - Teil 7: Anforderungen und Prüfverfahren für
Reinigungs-Desinfektionsgeräte mit chemischer Desinfektion für nicht invasive, nicht
kritische thermolabile Medizinprodukte und Zubehör im Gesundheitswesen (ISO 15883-
7:2016)
Laveurs désinfecteurs - Partie 7: Exigences et essais pour les laveurs désinfecteurs
utilisant la désinfection chimique pour les dispositifs médicaux et les équipements de
soins thermosensibles non invasifs et non critiques (ISO 15883-7:2016)
Ta slovenski standard je istoveten z: EN ISO 15883-7:2016
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 15883-7
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2016
EUROPÄISCHE NORM
ICS 11.080.10
English Version
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)
Laveurs désinfecteurs - Partie 7: Exigences et essais Reinigungs-Desinfektionsgeräte - Teil 7:
pour les laveurs désinfecteurs utilisant la désinfection Anforderungen und Prüfverfahren für Reinigungs-
chimique pour les dispositifs médicaux et les Desinfektionsgeräte mit chemischer Desinfektion für
équipements de soins thermosensibles non invasifs et nicht invasive, nicht kritische thermolabile
non critiques (ISO 15883-7:2016) Medizinprodukte und Zubehör im Gesundheitswesen
(ISO 15883-7:2016)
This European Standard was approved by CEN on 8 February 2016.

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
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15883-7:2016 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 15883-7:2016) 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 September 2016, and conflicting national standards
shall be withdrawn at the latest by September 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 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 11737-1 EN ISO 11737-1:2006 + ISO 11737-1:2006 +
EN ISO 11737-1:2006/AC:2009 ISO 11737-1:2006/Cor 1:2007
ISO 11737-2 EN ISO 11737-2:2009 ISO 11737-2:2009
ISO 15883-1 EN ISO 15883-1:2009 + ISO 15883-1:2006 +
EN ISO 15883-1:2009/A1:2014 ISO 15883-1:2006/Amd1:2014
ISO 15883-2 EN ISO 15883-2:2009 ISO 15883-2:2006
ISO 15883-3 EN ISO 15883-3:2009 ISO 15883-3:2006
ISO 15883-4 EN ISO 15883-4:2009 ISO 15883-4:2008
ISO 15883-6 EN ISO 15883-6:2015 ISO 15883-6:2011
ISO/TS 15883-5 CEN ISO/TS 15883-5:2005 ISO/TS 15883-5:2005
IEC 61010–2-040 EN 61010-2-040:2005 IEC 61010-2-040:2005
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 15883-7:2016 has been approved by CEN as EN ISO 15883-7:2016 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 standardization request M/023
concerning the development of European standards 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]
Essential Requirements of EU Clause(s)/subclause(s) of this Remarks/Notes
Directive 93/42/EEC European Standard
7.2 9 In addition requirements of
EN ISO 15883-1 apply.
Reference to
IEC 61010-2-040:2005, Clause 5
included in respect of packaging
only
7.3 4.1.1, 4.1.4
7.4  WD is not designed to deal with
such medical products
7.5 4.1.1 Including reference to
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.24.1
Essential Requirements of EU Clause(s)/subclause(s) of this Remarks/Notes
Directive 93/42/EEC European Standard
7.6 4.1.1, 4.7.1
8.1 4.1.1, 4.3, 4.5, 4.7.2 Including reference to
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
4.3.1
9.1 4.1.1, 4.1.3, 5.1.1, 8 a) Including reference to
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.1.9, 5.1.10, 5.6 and 5.28
9.2 4.1.1, 4.1.3, 5.1.1, 5.1.2 Including reference to
IEC 61010-2-040:2005, 5.4.3 and
7.5
9.3  WDs are unlikely to be
manufactured of or to contain
flammable or explosive substances
10.1  Not likely to apply, see MEDDEV 2.1
11  Intended hazardous radiation is
unlikely to be emitted by a WD
12.1 4.1.1
12.5 4.1.1 Including reference to
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.2.2
12.6 4.1.1 Including reference to
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.2.1
12.7.1 4.1.1 Including reference to
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.2.1
12.7.2 4.1.1 Including reference to
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.2.1
12.7.3 4.1.1 Including reference to
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.2.1
12.7.5 4.1.1 Including reference to
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.2.1
Essential Requirements of EU Clause(s)/subclause(s) of this Remarks/Notes
Directive 93/42/EEC European Standard
12.9 4.1.1
13.1 4.1.1
13.2 4.1.1 Including reference to
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.10.3
13.3 a), b), d) 4.1.1 Including reference to
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014, 9.1
13.3 i) 4.1.1 Including reference to
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.29
13.3 k) 4.1.1 Including reference to
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.2.3
13.3 I) 4.1.1 Including reference to
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014, 9.1
13.4 4.1.1 Including reference to
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
8.1 b)
13.6 a)  Including reference to
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014, 9.1
13.6 b) 8 f) Including reference to
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014, 8.3
13.6 c) 4.1.4, 4.3.4 Including reference to
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
8.2 h)
13.6 d) 8 a), c), h) Including reference to
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
6.1.3.2, 8.1 and 8.3 g)
13.6 q) 8 Including reference to
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
Clause 8
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 Qualifying remarks/Notes
Requirements (EHSRs) of European Standard
Directive 2006/42/EC
1 4.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.2.3 and 5.2.4
1.1.2 4.1.1, 5.1.1, 5.1.2 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014, 5.1
1.1.3 4.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.1.1, 5.1.2, 5.2 and 5.3.2 a)
1.1.5 4.1.1 See in addition
EN ISO 15883-1:2009, 9.2
1.1.6 4.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.12.3, 5.27.1 and 6.6.2
1.1.7 4.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014, 5.2
1.2.1, 1st dash and 2nd dash 4.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.2.2, 5.2.4, 5.12.1, 5.20 and 5.22
1.2.2, 1st dash 4.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014, 5.2,
5.12.3, 5.12.8 and 5.12.9
1.2.3 4.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.2.1
1.2.4.1 4.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.2.1 and 5.19
Essential Health and Safety Clause(s)/sub-clause(s) of this Qualifying remarks/Notes
Requirements (EHSRs) of European Standard
Directive 2006/42/EC
1.2.5 4.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.18 and 5.19
1.2.6 4.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014, 5.2
and 5.4.1.9
1.3.1 4.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.2.1
Including reference to
EN 61010-2-040:2005, 7.3
1.3.2 4.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014, 5.1,
5.2.1 and 8.3 g)
1.3.3 4.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.2.1
1.3.4 4.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.1.6 and 5.2.1
Including reference to
EN 61010-2-040:2005, Clause 7
1.3.7 4.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.2.1
1.3.8 4.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.2.1
1.3.9 4.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.2.1
1.5.1 4.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.2.1
1.5.2 4.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.2.1
Essential Health and Safety Clause(s)/sub-clause(s) of this Qualifying remarks/Notes
Requirements (EHSRs) of European Standard
Directive 2006/42/EC
1.5.3 4.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.2.1
1.5.4 4.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.2.1 and 8.3
1.5.5 4.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.2.1
1.5.6 4.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.2.1 and 5.8
1.5.7 4.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.2.1
1.5.8 4.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.2.1
1.5.9 4.1.1 See in addition
EN ISO 15883-1:2009, 5.2.1
1.5.13 4.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.2.1 and 8.1 b)
Including reference to
EN 61010-2-040:2005, Clause 11
1.5.14 4.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.2.1
Including reference to
EN 61010-2-040:2005, Clause 15
1.5.15 4.1.1, 5.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.2.1
1.5.16 4.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.2.1
Essential Health and Safety Clause(s)/sub-clause(s) of this Qualifying remarks/Notes
Requirements (EHSRs) of European Standard
Directive 2006/42/EC
1.6.1 4.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.1.5 and 5.2.1
1.6.2 4.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.1.5 and 5.2.1
1.6.3 4.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.2.1 and 8.2 a) and b)
1.6.4 4.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.2.1 and 5.4.1.6
1.6.5 4.1.1, 4.5 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
4.2.1.1 and 5.1.10
1.7.1 4.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.2.1, 5.10.2, 5.10.3 and 5.20 h)
1.7.2 4.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.2.1 and 8 f)
1.7.3 4.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.2.1 and 9.1
1.7.4 4.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
Clause 7 and Clause 8
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 product(s) falling within the scope of
this standard.
INTERNATIONAL ISO
STANDARD 15883-7
First edition
2016-02-01
Washer-disinfectors —
Part 7:
Requirements and tests for washer-
disinfectors employing chemical
disinfection for non-invasive, non-
critical thermolabile medical devices
and healthcare equipment
Laveurs désinfecteurs —
Partie 7: Exigences et essais pour les laveurs désinfecteurs utilisant la
désinfection chimique pour les dispositifs médicaux et les équipements
de soins thermosensibles non invasifs et non critiques
Reference number
ISO 15883-7:2016(E)
©
ISO 2016
ISO 15883-7:2016(E)
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
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the requester.
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ii © ISO 2016 – All rights reserved

ISO 15883-7:2016(E)
Contents Page
Foreword .v
Introduction .vi
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 Disinfection . 3
4.4 Final rinsing . 5
4.5 Self-disinfection . 5
4.6 Drying . 6
4.7 Water treatment equipment. 6
4.7.1 General. 6
4.7.2 Disinfection of water treatment equipment . 6
4.7.3 Maintenance of piping . 7
5 Mechanical requirements . 7
5.1 Materials — Design, manufacture, and assembly . 7
5.2 Process verification . 7
6 Testing for conformity . 7
6.1 General . 7
6.2 Test load . 8
6.2.1 Loading with standard goods . 8
6.2.2 Loading with special goods . 8
6.3 Water used for rinsing following disinfection . . 8
6.4 Load dryness . 8
6.4.1 General. 8
6.4.2 Procedure . 8
6.4.3 Results . 8
6.5 Thermometric tests . 8
6.5.1 General. 8
6.5.2 Load temperature test . . 8
6.6 Chemical dosing tests . 9
6.6.1 General. 9
6.6.2 Reused process chemicals . 9
6.7 Tests of cleaning efficacy . 9
6.7.1 General. 9
6.7.2 Materials . 9
6.7.3 Procedure .10
6.7.4 Results .10
6.8 Test of disinfection efficacy .10
6.8.1 General.10
6.8.2 Preliminary tests on chemical disinfectants .10
6.8.3 Self-disinfection tests .11
6.8.4 Chemical disinfection of the load.12
7 Documentation .12
8 Information to be provided by the manufacturer .12
9 Marking, labelling, and packaging .13
10 Information to be requested from the purchaser by the manufacturer .13
Annex A (normative) Summary of test programmes .14
ISO 15883-7:2016(E)
Annex B (normative) Methods for microbiological evaluation of disinfection of liquid
transport system.16
Annex C (normative) Tests for microbiological contamination of post-disinfection rinse water .21
Annex D (normative) Preparation and evaluation of indicators for microbiological testing
of the efficacy of chemical disinfection of the load .22
Annex E (informative) Examples of test locations for the tests with biological indicators .26
Bibliography .30
iv © ISO 2016 – All rights reserved

ISO 15883-7:2016(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
ISO 15883-7 was prepared by the European Committee for Standardization (CEN) Technical Committee
CEN/TC 102, Sterilizers for medical purposes, in collaboration with Technical Committee ISO/TC 198,
Sterilization of health care products, in accordance with the Agreement on technical cooperation
between ISO and CEN (Vienna Agreement).
ISO 15883 consists of the following parts, under the general title Washer-disinfectors:
— Part 1: General requirements, terms and definitions and tests
— Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical
instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
— Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human
waste containers
— Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for
thermolabile endoscopes
— Part 5: Test soils and methods for demonstrating cleaning efficacy [Technical Specification]
— Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive,
non-critical medical devices and healthcare equipment
— 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(E)
Introduction
It is intended that this introduction is to be read in conjunction with the introduction to ISO 15883-1.
This part of ISO 15883 is the seventh of a series specifying the performance of washer-disinfectors.
It specifies the particular requirements for performance applicable to washer-disinfectors employing
chemical disinfection for non-invasive, non-critical thermolabile medical devices, and healthcare
equipment. Its requirements apply to washer-disinfectors used for cleaning and disinfection of
thermolabile equipment for use without further treatment in healthcare settings. Such reusable
equipment needs to be cleaned and disinfected, but processing in a washer-disinfector for surgical
instruments (see ISO 15883-2), for human waste containers (see ISO 15883-3), for endoscopes
(see ISO 15883-4), or for non-invasive, non-critical medical devices, and healthcare equipment
employing thermal disinfection (see ISO 15883-6) is inappropriate and/or impractical. Examples of
such equipment are bedsteads and bedside furniture, trolleys and transport carts, operating tables,
footwear, wheelchairs, or aids for the disabled.
Requirements for washer-disinfectors for other applications are specified in other parts of ISO 15883.
In respect to any potential adverse effects on the quality of water intended for human consumption
caused by use of the washer-disinfector, it is noteworthy that
a) until verifiable international criteria are adopted, the existing national regulations concerning
the use and/or characteristics of the washer-disinfector remain in force (e.g. the requirement of
backflow prevention), and
b) the ISO 15883 series of standards provides no information as to whether the washer-disinfector
may be used without restriction in any of the ISO member states.
vi © ISO 2016 – All rights reserved

INTERNATIONAL STANDARD ISO 15883-7:2016(E)
Washer-disinfectors —
Part 7:
Requirements and tests for washer-disinfectors employing
chemical disinfection for non-invasive, non-critical
thermolabile medical devices and healthcare equipment
1 Scope
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 reusable items such as
the following:
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, ISO 15883-3, ISO I5883-4, and ISO 15883-6 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 requalifications 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 reusable 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.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 15883-7:2016(E)
ISO 15883-1:2006+A1:2014, Washer-disinfectors — Part 1: General requirements, terms and
definitions and tests
ISO 15883-4, Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing
chemical disinfection for thermolabile endoscopes
ISO 15883-6, Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing
thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment
ISO/TS 15883-5:2005, Washer-disinfectors — Part 5: Test soils and methods for demonstrating
cleaning efficacy
EN 10088-1, Stainless steels — Part 1: List of stainless steels
EN 10088-2, Stainless steels — Part 2: Technical delivery conditions for sheet/plate and strip of corrosion
resisting steels for general purposes
IEC 61010-2-040:2005, Safety requirements for electrical equipment for measurement, control and
laboratory use — Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat
medical materials
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 15883-1, ISO 15883-4, and
ISO 15883-6 apply.
4 Performance requirements
4.1 General
4.1.1 The WD shall conform to ISO 15883-1:2006+A1:2014 except for the following subclauses:
— 4.3.1 (which refers to thermal disinfection);
— 5.9 [process temperature control limits, excluding 5.9 d) and e)];
— 5.11 (process verification).
4.1.2 The WD shall be designed to clean and chemically disinfect the range of reusable items specified.
4.1.3 When necessary, the WD shall be provided with means to facilitate the correct alignment of the
load in the washing chamber.
4.1.4 The means to control the volume of the process chemical(s) admitted (see ISO 15883-
1:2006+A1:2014, 5.7.4 and 5.7.5) shall be adjustable by means of a key, code, or tool. The accuracy of the
dosing system shall be at least ±10 % or as specified and tested for conformity (see 6.6).
4.1.5 The automatic controller shall ensure that the final concentration of disinfectants are within the
limits specified.
NOTE Confirmation of the concentration of disinfectant can include the measurement of the volume of
disinfectant and water admitted together with a certificate of conformity from the disinfectant supplier for the
concentration of the disinfectant, together with data to support the shelf life, expiry date, etc.
2 © ISO 2016 – All rights reserved

ISO 15883-7:2016(E)
4.2 Cleaning
4.2.1 Cleaning shall be tested in accordance with the requirements of ISO 15883-1 using the test soils
and methods described in ISO/TS 15883-5 that are relevant to the loads to be processed.
4.2.2 During the washing stage:
a) the washing stage starts when the temperature at the control sensor of the WD is not less than the
specified washing temperature;
b) the washing temperature band shall have the lower limit defined by the washing temperature
and an upper limit of not greater than the specified washing temperature +10 °C (see
ISO 15883-1:2006+A1:2014, 4.2.3).
4.2.3 Cleaning efficacy shall be determined in accordance with 6.7.
4.2.4 If the WD is designed to allow the reuse of the cleaning solution on two or more consecutive
operating cycles, then care shall be taken to ensure that the efficacy and safety (e.g. accumulation of
foreign material, device compatibility) of the cleaning solution is not impaired. This shall include at least
the following:
a) specified methods which shall be used to ensure that the cleaning solution has retained the required
cleaning efficacy. These methods shall be based on validation studies, which would normally be
carried out by the cleaning solution manufacturer, to determine a suitable parameter, parameters
and/or indicators/markers that may be monitored. Suitable parameters may include the concentration
of the active ingredient and other ingredients that may also affect performance (e.g. pH);
NOTE Minor changes in formulation of the cleaning solution can have a significant effect on its stability,
cleaning efficacy, etc.
b) recommendations to the user for the maximum period or number of operating cycles for which the
cleaning solution may be used. This shall be based on validated experimental data;
c) where validated use conditions (maximum period or number of operating cycles) are exceeded, the
automatic controller shall
— operate an audible and visible alarm and prevent the use of the operating cycle until the cleaning
solution is changed, or
— effect an automatic change of the cleaning solution in the WD.
4.3 Disinfection
4.3.1 The cycle shall include a chemical disinfection stage, which may be combined with the cleaning
and shall be deemed to have been achieved when testing requirements in 6.8 are met.
4.3.2 The requirements and tests in this part of ISO 15883 are based on the use of aqueous disinfectant
solutions. Other systems based on gaseous disinfectants are not excluded; equivalent tests are required.
These shall include the following:
a) disinfectant(s) to be used, for which in vitro efficacy has been demonstrated based on relevant
published standards;
ISO 15883-7:2016(E)
For the purpose of efficacy testing, a validated neutralization method shall be used. This method can be
provided by the disinfectant manufacturer.
b) when tested on surfaces for the minimum exposure time at the minimum concentra
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