EN ISO 15883-1:2009/A1:2014

SLOVENSKI STANDARD
01-oktober-2014
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Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO
15883-1:2006/Amd 1: 2014)
Reinigungs-Desinfektionsgeräte - Teil 1: Allgemeine Anforderungen, Begriffe und
Prüfverfahren (ISO 15883-1:2006/Amd 1: 2014)
Laveurs désinfecteurs - Partie 1: Exigences générales, termes et définitions et essais
(ISO 15883-1:2006/Amd 1: 2014)
Ta slovenski standard je istoveten z: EN ISO 15883-1:2009/A1:2014
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 15883-1:2009/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2014
ICS 11.080.10
English Version
Washer-disinfectors - Part 1: General requirements, terms and
definitions and tests (ISO 15883-1:2006/Amd 1:2014)
Laveurs désinfecteurs - Partie 1: Exigences générales, Reinigungs-Desinfektionsgeräte - Teil 1: Allgemeine
termes et définitions et essais (ISO 15883-1:2006/Amd Anforderungen, Begriffe und Prüfverfahren (ISO 15883-
1:2014) 1:2006/Amd 1:2014)
This amendment A1 modifies the European Standard EN ISO 15883-1:2009; it was approved by CEN on 21 June 2014.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this
amendment into the relevant 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 amendment 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
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15883-1:2009/A1:2014 E
worldwide for CEN national Members.

Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices .4

Foreword
This document (EN ISO 15883-1:2009/A1:2014) 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 Amendment to the European Standard EN ISO 15883:2009 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by January 2015, and
conflicting national standards shall be withdrawn at the latest by January 2015.
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.
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 15883-1:2006/Amd 1:2014 has been approved by CEN as EN ISO 15883-1:2009/A1:2014
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 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 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 European Standard and Directive 93/42/EEC
on medical devices
Clauses/subclauses of this Essential requirements Qualifying remarks/Notes
European Standard (ERs)of EU Directive
93/42/EEC
4,5.2.1, 5.4.1.2, 5.5.1, 5.7, 7.2 Including reference to EN 61010–2-
5.24, 5.25, 6.10, 6.11, 6.12,
040:2005, 5.4.4 b), e), f), 5.4.5 and
9.2 5.4101
4.6, 5.1, 5.2, 5.7, 6.9 7.3 Including reference to EN 61010–2-
040:2005, 5.4.3 k), m), 11.1 and
11.2
5.1.7, 5.1.8, 5.2, 5.4, 5.4.1.2, 7.5 Including reference to EN 61010–2-
5.4.5.3, 6.5.3, 5.24, 5.25, 040:2005, 5.2, 11.3 and 11.4
8.2 g), and h), 10 c)
4.5.3, 4.5.4, 5.3.2, 5.26, 6.11 7.6 Including reference to EN 61010–2-

040:2005, 5.3.4 and 11.101
4, 5.2, 5.3.1, 5.3.2, 5.4.3, 8.1
5.4.4, 5.5.1, 5.24, 5.26, 6.1,
6.2, 6.11
3, 4, 5.1.11, 5.2, 8.1 b), 8.3 9.1 Including reference to EN 61010–2-
040:2005, 5.4.3, Clause 14,
ISO 14121:1999,
EN ISO 14971:2013 and
EN 61508–1:2010
4, 5.1, 5.1.5, 5.1.9, 5.2.1, 9.2 Including reference to EN 61010–2-
5.2.2, 5.2.3, 5.4.1.9, 5.4.2, 040:2005, Clause 7,
5.4.3.4, 5.10.2, 5.10.3, ISO 14121:1999 and EN 61508–
5.27.1, 5.28, 5.29 1:2010
5.2 9.3
5.7 10.1
5.2.1, 5.2.2, 8.2 c) and d) 11.1 Including reference to EN 61010–2-
040:2005, Clause 12 and
EN 61326–1:2006
5.2.1, 5.2.2 11.4.1 Including reference to EN 61010–2-
040:2005, Clause 12 and
EN 61326–1:2006
5.2.1, 5.2.4, 5.4, 5.7.4, 5.7.6, 12.1 Including reference to EN 61010–2-
5.8., 5.11, 5.12.7, 5.12.8,
040:2005, 4.4, 7.104, 14.103 and
5.12.9, 5.12.10, 5.13.2 g), 14.104, and EN ISO 14971:2013
5.14 g), 5.17.2, 5.18, 5.20,
State of the art comprehends many
5.21
standards; note refers to
EN ISO 12100:2003,
ISO 13489-2:2003, and EN 954–
1:1997
5.2 12.5 Including reference to EN 61326–
1:2006
5.2 12.6 Including reference to EN 61010–2-
040:2005, 1.4, Clauses 4, 5 and 6,
11.6, Clause 14.
Note refers to ISO 14121:1999 and
EN 61508–1:2010
5.1, 5.2, 5.4, 5.27.1 b) 12.7.1 Including reference to EN 61010–2-

040:2005, 7.2, 7.3 and 7.4.101
5.2 12.7.2 Including reference to EN 61010–2-
040:2005, Clause 8
5.2 12.7.3 Including reference to EN 61010–2-
040:2005, 12.5.1
5.2 12.7.4 Including reference to EN 61010–2-
040:2005, Clause 6
5.2, 5.8 12.7.5 Including reference to EN 61010–2-
040:2005, 10.1
5.10, 5.12 12.9 Including reference to
IEC 60417:2004, ISO 7000:2012
and IEC 80416–1:2008
5.2, 5.4.1.3, 5.4.2, 5.23, 7, 8, 13.1 Including reference to EN 61010–2-
9.1 040:2005, Clause 5
5.10.3 13.2 Including reference to
IEC 60417:2004, ISO 7000:2012
and IEC 80416–1:2008
9.1 b) and c) 13.3 k)
9.1 a) 13.3 I)
8.1 b) 13.4
8 k), 8 a), 8 j), 13.6 a)
5.2.3, 7, 8, 9.1 13.6 a), b), c), d) Including reference to EN 61010–2-
040:2005, 5.1.2
8.1, 6.1.3 13.6 i)
8.3 j) 13.6 q)
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
5.2.3, 5.2.4 1
5.1.1, 5.2, 5.3.2.1 a) 1.1.3
9.2 1.1.5
5.12.3, 6.6.2 1.1.6
5.2 1.1.7
5.12.1 1.2.1
5.2, 5.18, 5.19 1.2.2
5.2 1.2.3
5.2, 5.18, 5.19 1.2.4
5.18, 5.19 1.2.5
5.2 1.2.6
5.4.1.5, 5.18.4, 5.22, 6.3.5, 6.3.7 1.3.1
5.1, 5.2, 8.3 g) 1.3.2
5.2 1.3.3
5.2, 5.6 1.3.4
5.2 1.3.7
5.2 1.5.1
5.2, 6.3.1 1.5.2
5.2 1.5.3
5.2 1.5.4
5.2 1.5.5
5.2 1.5.6
5.2 1.5.8
5.2 1.5.13
5.2, 5.4.1.7 1.5.14
5.2, 8.3 g) 1.6.1
5.1.5 1.6.2
5.2 1.6.3
5.1.5 1.6.5
5.2, 5.10, 5.10.3, 5.12.3, 5.22, 1.7.1
8.3 a), 8.3 b)
5.2 1.7.2
5.2, 9.1 1.7.3
5.2, 8.3, 9.1 1.7.4
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this
standard.
INTERNATIONAL ISO
STANDARD 15883-1
First edition
2006-04-15
AMENDMENT 1
2014-07-15
Washer-disinfectors —
Part 1:
General requirements, terms and
definitions and tests
AMENDMENT 1
Laveurs désinfecteurs —
Partie 1: Exigences générales, termes et définitions et essais
AMENDEMENT 1
Reference number
ISO 15883-1:2006/Amd.1:2014(E)
©
ISO 2014
ISO 15883-1:2006/Amd.1:2014(E)

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ISO 15883-1:2006/Amd.1:2014(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. 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. 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
The committee responsible for this document is ISO/TC 198, Sterilization of health care products in
collaboration with European Committee for Standardization (CEN) Technical Committee TC 102,
Sterilizers for medical purposes, in accordance with the Agreement on technical cooperation between
ISO and CEN (Vienna Agreement).
...