SIST EN ISO 15883-1:2009/A1:2014

Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006/Amd 1: 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.

Reinigungs-Desinfektionsgeräte - Teil 1: Allgemeine Anforderungen, Begriffe und Prüfverfahren (ISO 15883-1:2006/Amd 1: 2014)

N/A

Laveurs désinfecteurs - Partie 1: Exigences générales, termes et définitions et essais (ISO 15883-1:2006/Amd 1: 2014)

Čistilno-dezinfekcijske naprave - 1. del: Osnovne zahteve, termini, definicije in preskusi (ISO 15883-1:2006/Amd 1: 2014)

Določa zahteve za učinkovitost čiščenja in razkuževanja ter za pripomočke, ki jih je mogoče zahtevati za dosego želene učinkovitosti. Podane so tudi metode in instrumenti, potrebni za validacijo, rutinski nadzor ter nadzorovanje in vnovično validacijo, periodično in po nujnih popravilih. Zahteve za čistilno-razkuževalne naprave za obdelavo določenih polnjenj so podane v nadaljnjih delih tega standarda. Za čistilno-razkuževalne naprave za obdelavo polnjenj dveh ali več različnih tipov veljajo zahteve za vse ustrezne dele tega standarda. Ta del standarda ISO 15883 ne določa zahtev za stroje, ki se uporabljajo za pranje perila ali posebne namene v gostinstvu. Ta del standarda ISO 15883 ne vključuje zahtev za stroje, ki se uporabljajo za sterilizacijo polnjenja ali so načrtovani kot sterilizatorji. Te zahteve so podane v drugih standardih, npr. EN 285. Določene zahteve tega standarda morda ne zagotavljajo inaktivacije ali odstranitve vzročnih povzročiteljev (prionskih beljakovin) prenosljivih spongiformnih encefalopatij. Ta del standarda ISO 15883 lahko uporabljajo potencialni kupci in proizvajalci kot osnovo za dogovor o specifikaciji čistilno-razkuževalne naprave. Preskusne metode za prikaz skladnosti z zahtevami tega dela standarda ISO 15883 lahko uporabijo uporabniki za prikaz trajne skladnosti nameščene čistilno-razkuževalne naprave med življenjsko dobo delovanja. V dodatku A so podane smernice za rutinski program preskušanja.

General Information

• Status: Published
• Public Enquiry End Date: 19-Aug-2012
• Publication Date: 20-Aug-2014
• ICS: 11.080.10 - Sterilizing equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 06-Aug-2014
• Due Date: 11-Oct-2014
• Completion Date: 21-Aug-2014
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• 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 15883-1:2009/A1:2014 - Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006/Amd 1:2014)

Relations

• Amends: SIST EN ISO 15883-1:2009 - Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006)
• Effective Date: 01-Oct-2014
• Revises: oSIST prEN ISO 15883-1:2021 - Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO/DIS 15883-1:2020)
• Effective Date: 18-Jan-2023
• Revises: oSIST prEN ISO 15883-1:2021 - Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO/DIS 15883-1:2020)
• Effective Date: 19-Jan-2023
• Revised: oSIST prEN ISO 15883-1:2021 - Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO/DIS 15883-1:2020)
• Effective Date: 01-Jan-2021

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 15883-1:2009/A1:2014
01-oktober-2014
ýLVWLOQRGH]LQIHNFLMVNHQDSUDYHGHO2VQRYQH]DKWHYHWHUPLQLGHILQLFLMHLQ
SUHVNXVL,62$PG
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
SIST EN ISO 15883-1:2009/A1:2014 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 15883-1:2009/A1:2014

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SIST EN ISO 15883-1:2009/A1:2014

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.

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SIST EN ISO 15883-1:2009/A1:2014
EN ISO 15883-1:2009/A1:2014 (E)
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

2

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SIST EN ISO 15883-1:2009/A1:2014
EN ISO 15883-1:2009/A1:2014 (E)
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.
3

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SIST EN ISO 15883-1:2009/A1:2014
EN ISO 15883-1:2009/A1:2014 (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 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
4

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SIST EN ISO 15883-1:2009/A1:2014
EN ISO 15883-1:2009/A1:2014 (E)
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)
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SIST EN ISO 15883-1:2009/A1:2014
EN ISO 15883-1:2009/A1:2014 (E)
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
6

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SIST EN ISO 15883-1:2009/A1:2014
EN ISO 15883-1:2009/A1:2014 (E)
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.
7

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SIST EN ISO 15883-1:2009/A1:2014
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

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SIST EN ISO 15883-1:2009/A1:2014
ISO 15883-1:2006/Amd.1:2014(E)

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ii © ISO 2014 – All rights reserved

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SIST EN ISO 15883-1:2009/A1:2014
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
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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
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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
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For an explana
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