EN ISO 15883-1:2009

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

ISO 15883-1:2006 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 ISO 15883. For washer-disinfectors intended to process loads of two or more different types the requirements of all relevant parts of this standard apply.
ISO 15883-1:2006 does not specify requirements intended for machines for use for laundry or general catering purposes.
ISO 15883-1:2006 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.
ISO 15883-1:2006 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 ISO 15883-1:2006 may also be employed by users to demonstrate continued compliance of the installed WD throughout its working life. Guidance on a routine test programme also is given.

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

Dieser Teil von ISO 15883 legt allgemeine Leistungsanforderungen an Reinigungs-Desinfektionsgeräte
(RDG) und deren Zubehör fest, die für die Reinigung und Desinfektion wieder verwendbarer Medizinprodukte
und anderer in der medizinischen, zahnmedizinischen, pharmazeutischen und veterinärmedizinischen Praxis
verwendeter Artikel vorgesehen sind. Sie legt die Leistungsanforderungen für die Reinigung und Desinfektion
sowie für das Zubehör fest, die zum Erreichen der erforderlichen Leistung notwendig sein können. Ebenso
werden die Verfahren und Messgeräte festgelegt, die für die Validierung, die Routineüberprüfung sowie,
Routineüberwachung und die Revalidierung, die in periodischen Abständen und nach wesentlichen Reparaturen
erfolgt, benötigt werden.
Die Anforderungen an die zur Behandlung spezifischer Beladungsgüter bestimmten RDG sind in folgenden
Teilen dieser Norm festgelegt. Für Reinigungs-Desinfektionsgeräte, die für die Behandlung von zwei oder
mehreren Arten von Beladungsgütern bestimmt sind, gelten die Anforderungen aller sie betreffenden Teile
dieser Norm.
Dieser Teil von ISO 15883 legt keine Anforderungen für Geräte fest, die für die Anwendung in Wäschereien
oder im Bereich der Lebensmittelzubereitung bestimmt sind.
Dieser Teil von ISO 15883 enthält keine Anforderungen an Geräte, die für die Sterilisation der Beladung
bestimmt sind oder als „Sterilisatoren“ bezeichnet werden; diese sind in anderen Normen, z. B. EN 285, festgelegt.
Es ist möglich, dass die in dieser Norm festgelegten Leistungsanforderungen nicht die Inaktivierung oder Beseitigung
von Erregern übertragbarer spongiformer Enzephalopathien (Prionenproteine) sicherstellen können.

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

L'ISO 15883-1:2006 spécifie les exigences générales de performances pour les laveurs désinfecteurs (LD) et leurs accessoires destinés à être utilisés pour nettoyer et désinfecter des dispositifs médicaux réutilisables ou tout autre article utilisé dans le contexte d'activités médicales, pharmaceutiques, dentaires et vétérinaires. Elle spécifie les exigences de performances pour le nettoyage et la désinfection ainsi que pour les accessoires qui peuvent être nécessaires pour atteindre les performances requises. Les méthodes et l'instrumentation nécessaires pour la validation, le contrôle de routine, la surveillance et la revalidation, réalisés périodiquement et après des réparations essentielles, sont aussi spécifiées.
Les exigences pour les laveurs désinfecteurs destinés à traiter des charges spécifiques sont spécifiées dans des parties subséquentes de l'ISO 15883. Les laveurs désinfecteurs destinés à traiter des charges d'au moins deux types différents doivent satisfaire les exigences de toutes les parties applicables de la présente norme.
L'ISO 15883-1:2006 ne spécifie aucune exigence concernant les laveurs désinfecteurs utilisés en blanchisserie ou en restauration générale.
L'ISO 15883-1:2006 n'inclut aucune exigence pour les laveurs désinfecteurs destinés à stériliser la charge ou considérés comme des «stérilisateurs»: celles-ci sont spécifiées dans d'autres normes, par exemple l'EN 285.
Les exigences de performance spécifiées dans cette norme peuvent ne pas assurer l'inactivation ou l'élimination de(s) l'agent(s) infectieux (protéine du prion) des encéphalopathies spongiformes transmissibles.
L'ISO 15883-1:2006 peut être utilisée par des acheteurs potentiels et des fabricants sur la base de l'accord sur la spécification d'un LD. Les méthodes d'essai pour la démonstration de conformité aux exigences de l'ISO 15883-1:2006 peuvent également être utilisées par les utilisateurs afin de démontrer une conformité continue du LD installé, au cours de sa durée vie. Des directives sur un programme d'essai de routine sont données dans l'Annexe A.

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

General Information

• Status: Withdrawn
• Publication Date: 02-Jun-2009
• Withdrawal Date: 13-Apr-2025
• ICS: 01.040.11 - Health care technology (Vocabularies)
• ICS: 11.080.10 - Sterilizing equipment
• Technical Committee: CEN/TC 102 - Sterilizers for medical purposes
• Drafting Committee: CEN/TC 102/WG 8 - Performance requirements and testing for washer-disinfectors
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 12-Mar-2025
• Completion Date: 14-Apr-2025
• 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: SIST EN ISO 15883-1:2009 - Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006)

Relations

• Replaces: EN ISO 15883-1:2006 - Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006)
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 15883-1:2025 - Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2024)
• Effective Date: 28-Jan-2023
• Amended By: 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)
• Effective Date: 03-Sep-2011

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2009
1DGRPHãþD
SIST EN ISO 15883-1:2006
ýLVWLOQRGH]LQIHNFLMVNHQDSUDYHGHO2VQRYQH]DKWHYHWHUPLQLGHILQLFLMHLQ
SUHVNXVL,62
Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO
15883-1:2006)
Reinigungs-Desinfektionsgeräte - Teil 1: Allgemeine Anforderungen, Begriffe und
Prüfverfahren (ISO 15883-1:2006)
Laveurs désinfecteurs - Partie 1: Exigences générales, termes et définitions et essais
(ISO 15883-1:2006)
Ta slovenski standard je istoveten z: EN ISO 15883-1:2009
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
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2009
ICS 11.080.10 Supersedes EN ISO 15883-1:2006
English Version
Washer-disinfectors - Part 1: General requirements, terms and
definitions and tests (ISO 15883-1:2006)
Laveurs désinfecteurs - Partie 1: Exigences générales, Reinigungs-Desinfektionsgeräte - Teil 1: Allgemeine
termes et définitions et essais (ISO 15883-1:2006) Anforderungen, Begriffe und Prüfverfahren (ISO 15883-
1:2006)
This European Standard was approved by CEN on 16 May 2009.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15883-1:2009: 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 .4

Foreword
The text of ISO 15883-1:2006 has been prepared by Technical Committee ISO/TC 198 “Sterilization of health
care products” of the International Organization for Standardization (ISO) and has been taken over as EN ISO
15883-1:2009 by 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 December 2009, and conflicting national standards shall be withdrawn
at the latest by March 2010.
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 15883-1:2006.
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 EC Directive.
For relationship with EC Directive, 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, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 15883-1:2006 has been approved by CEN as a EN ISO 15883-1:2009 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential Requirements of
EU Directive 93/42/EEC
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 Communities 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 Essential requirements Qualifying remarks/Notes
thisEuropean Standard (ERs)of EU Directive
93/42/EEC
1, 4, 3, 6, 7.1, 8.1, 9.1, 7.2, 9.2
2, 7.3
5.1
5.1.3
5.1.7 7.5
5.1.8 7.5
5.2 1, 2, 6, 7.1, 7.2, 7.3, 7.5, 8.1, 9.1, The WD shall comply with the
9.2, 9.3, 12.5, 12.6, 12.7.1, 12.7.2,
requirements of IEC 61010-2-045
12.7.3, 12.7.4, 12.7.5, 13.1
5.4 7.5 Refers only to leakage
5.4.1.2 7.2, 7.5
5.4.1.3 13.1
5.4.1.5 1, 2
5.4.1.6 1, 2
5.4.1.7 1, 2
5.4.1.8 1, 2
5.4.2 13.1
5.4.3 8.1
5.4.4 8.1
5.4.5.2 2
5.4.5.3 2, 7.5
Table ZA.1 (continued)
Clauses/subclauses of Essential requirements Qualifying remarks/Notes
thisEuropean Standard (ERs)of EU Directive
93/42/EEC
5.5.1 2, 7.2
5.5.2 2
5.7 3, 7.2, 7.3
5.8 2, 12.1, 12.7.5
5.9 3
5.10. 13.2
5.11.1 3
5.11.2 2, 3
5.11.3 2, 3 The choice of process verification
system shall be based on a
documented risk analysis
5.11.4 2, 3
5.12 3, 12.9
5.13 3
5.14 3
5.15 3
5.16 3
5.17 3
5.18 3
5.19 3
5.20 12.1
5.21 12.1
5.22 2, 3
5.23 3, 13.1
5.24 7.2, 7.5
5.25 7.2, 7.5
5.27 3
5.28 3
Table ZA.1 (continued)
Clauses/subclauses of Essential requirements Qualifying remarks/Notes
thisEuropean Standard (ERs)of EU Directive
93/42/EEC
5.29 3
6.1 1, 2, 3, 6, 7.1, 8.1 Testing for conformity
6.2 1, 2, 3, 6, 7.1, 8.1 Testing for conformity
6.3.5 2, 3
6.3.6 2, 3
6.3.7 2, 3
6.4 3
6.5.3 7.5
6.5.4 3
6.5.5 3
6.5.6 3
6.6 3
6.7 3
6.8 3
6.9 3, 7.3
6.10 3, 7.2, 7.5
6.11 3, 7.2, 7.5
6.12 3, 7.2, 7.5
6.13 3, 7.2, 7.5
7 13
8 13.1, 13.3, 13.4, 13.6
9 5, 13.3
10 1
- 12.1a) This relevant Essential Requirement is
not addressed in this European
Standard
7, 8, 9 13.3 a) This relevant Essential Requirement is
partly addressed in this European
Standard
- 13.6 q) This relevant Essential Requirement is
not addressed in this European
Standard
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
EN Requirements (EHSRs) of
Directive 2006/42/EC
5.1.1, 5.2, 5.3.2.1 a) 1.1.3 This relevant EHSR is partly
addressed in this Standard
9.2 1.1.5 This relevant EHSR is partly
addressed in this Standard
5.12.3, 6.6.2 1.1.6 This relevant EHSR is partly
addressed in this Standard
5.2 1.1.7 This relevant EHSR is addressed
in this Standard
5.12.1 1.2.1 This relevant EHSR is partly
addressed in this Standard
5.2, 5.18, 5.19 1.2.2 This relevant EHSR is addressed
in this Standard
5.2 1.2.3 This relevant EHSR is addressed
in this Standard
5.2, 5.18.5.19 1.2.4 This relevant EHSR is addressed
in this Standard
5.18, 5.19 1.2.5 This relevant EHSR is addressed
in this Standard
5.2 1.2.6 This relevant EHSR is partly
addressed in this Standard
5.4.1.5, 5.18.4, 5.22, 6.3.5, 6.3.7 1.3.1 This relevant EHSR is partly
addressed in this Standard
5.1, 5.2, 8.3 g) 1.3.2 This relevant EHSR is addressed
in this Standard
5.2 1.3.3 This relevant EHSR is addressed
in this Standard
5.2, 5.6 1.3.4 This relevant EHSR is addressed
in this Standard
5.2 1.3.7 This relevant EHSR is partly
addressed in this Standard
5.2 1.3.8.1 This relevant EHSR is partly
addressed in this Standard
5.2 1.3.8.2 This relevant EHSR is partly
addressed in this Standard
1.3.9 This relevant EHSR is not
addressed in this Standard
1.4.1 This relevant EHSR is not
addressed in this Standard
1.4.2 This relevant EHSR is not
addressed in this Standard
Table ZA.2 (continued)
Clause(s)/sub-clause(s) of this Essential Health and Safety Qualifying remarks/Notes
EN Requirements (EHSRs) of
Directive 2006/42/EC
1.4.3 This relevant EHSR is not
addressed in this Standard
5.2 1.5.1 This relevant EHSR is addressed
in this Standard
5.2, 6.3.1 1.5.2 This relevant EHSR is addressed
in this Standard
5.2 1.5.3 This relevant EHSR is addressed
in this Standard
5.2 1.5.4 This relevant EHSR is partly
addressed in this Standard
5.2 1.5.5 This relevant EHSR is addressed
in this Standard
5.2 1.5.6 This relevant EHSR is addressed
in this Standard
5.2 1.5.8 This relevant EHSR is addressed
in this Standard
1.5.9 This relevant EHSR is not
addressed in this Standard
5.2 1.5.13 This relevant EHSR is addressed
in this Standard
5.2, 5.4.1.7 1.5.14 This relevant EHSR is addressed
in this Standard
5.2, 8.3 g) 1.6.1 This relevant EHSR is partly
addressed in this Standard
5.1.5 1.6.2 This relevant EHSR is addressed
in this Standard
5.2 1.6.3 This relevant EHSR is addressed
in this Standard
5.1.5 1.6.4 This relevant EHSR is addressed
in this Standard
5.1.5 1.6.5 This relevant EHSR is addressed
in this Standard
5.2, 5.10, 5.10.3, 5.12.3, 5.22, 1.7.1 This relevant EHSR is partly
8.3 a), 8.3 b) addressed in this Standard
5.2 1.7.2 This relevant EHSR is partly
addressed in this Standard
5.2, 9.1 1.7.3 This relevant EHSR is partly
addressed in this Standard
5.2, 8.3, 9.1 1.7.4 This relevant EHSR is partly
addressed in this Standard
4 This relevant EHSR is not
addressed in this standard
INTERNATIONAL ISO
STANDARD 15883-1
First edition
2006-04-15
Washer-disinfectors —
Part 1:
General requirements, terms
and definitions and tests
Laveurs désinfecteurs —
Partie 1: Exigences générales, termes et définitions et essais

Reference number
ISO 15883-1:2006(E)
©
ISO 2006
ISO 15883-1:2006(E)
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ii © ISO 2006 – All rights reserved

ISO 15883-1:2006(E)
Contents Page
Foreword. v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 2
4 Performance requirements . 8
4.1 General. 8
4.2 Cleaning. 10
4.3 Disinfection . 10
4.4 Rinsing. 11
4.5 Drying. 11
4.6 Process chemicals. 12
5 Mechanical and process requirements . 12
5.1 Materials, design and manufacture/construction. 12
5.2 Safety . 14
5.3 Calorifiers and tanks . 14
5.4 Loading and unloading doors and their controls. 15
5.5 Pipework and fittings. 17
5.6 Spray systems. 17
5.7 Dosing systems . 18
5.8 Load temperature protection. 18
5.9 Process temperature control limits . 19
5.10 Switches, gauges and indicating devices. 20
5.11 Process verification. 20
5.12 Instrumentation and controls . 21
5.13 Temperature indicating systems. 22
5.14 Pressure indicating systems . 23
5.15 Timing equipment. 23
5.16 Operating cycle indicating equipment. 23
5.17 Recording instruments (if fitted). 23
5.18 Control systems. 25
5.19 Override of automatic control . 26
5.20 Microprocessor control systems . 27
5.21 Access to software . 27
5.22 Fault indication systems. 27
5.23 Water supply . 28
5.24 Venting and drainage systems. 28
5.25 Drainage. 29
5.26 Air filters installed within the WD. 29
5.27 Load handling and supports for use within the WD . 29
5.28 Trolleys . 30
5.29 Environment . 31
6 Testing for conformity. 31
6.1 General. 31
6.2 Test equipment . 34
6.3 Tests on doors, interlocks and fault indications. 35
6.4 Tests on water quality and water volume . 37
6.5 Tests on pipework . 39
6.6 Tests on instrumentation fitted to the WD .41
ISO 15883-1:2006(E)
6.7 Tests on load carriers. 42
6.8 Thermometric tests. 43
6.9 Chemical dosing tests . 46
6.10 Tests of cleaning efficacy . 47
6.11 Tests of air quality . 48
6.12 Load dryness test . 49
6.13 Automatic control test . 49
7 Documentation . 50
8 Information to be supplied by the manufacturer . 50
8.1 General . 50
8.2 Before delivery of the WD and for installation. 51
8.3 At delivery of the WD . 51
9 Marking, labelling and packaging . 53
9.1 Marking and labelling . 53
9.2 Packaging . 53
10 Information to be requested from the purchaser by the supplier of the WD. 53
Annex A (informative) Test programme . 55
Annex B (informative) A concept — Comparative lethality of moist heat processes . 59
Annex C (normative) Test methods for the detection and assessment of residual proteinaceous
contamination. 63
Annex D (normative) Microbiological recovery medium for estimation of bacterial contamination
of water. 68
Bibliography . 69

iv © ISO 2006 – All rights reserved

ISO 15883-1:2006(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 15883-1 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]
ISO 15883-1:2006(E)
Introduction
This part of ISO 15883 is the first of a series of standards specifying the performance of washer-disinfectors
and specifies the general requirements for performance applicable to all washer-disinfectors. The
requirements given in this part of ISO 15883 are applicable to all washer-disinfectors specified in subsequent
parts of the ISO 15883 series, except insofar as they may be modified or added to by a subsequent part, in
which case the requirements of that particular part will apply.
Fields of application within the scope of ISO 15883 series include laboratory, veterinary, dental and
pharmaceutical applications and other specific applications, such as washer-disinfectors for bedsteads and
transport carts and the disinfection of crockery and cutlery intended for use with immunologically
compromised patients.
Washer-disinfectors should be used only for processing the type of loads specified by the manufacturer of the
washer-disinfector.
In selecting the appropriate washer-disinfector, reference should be made both to this part of ISO 15883 and
to the relevant subsequent parts of ISO 15883 series. It is the user’s responsibility to ensure that the choice of
type of washer-disinfector, operating cycle or quality of services or process chemicals is appropriate for any
particular load.
Safety requirements for washer-disinfectors are given in IEC 61010-2-045.
This part of ISO 15883 has been prepared on the basis that each individual washer-disinfector will be subject
to validation tests (commissioning and performance qualification on first installation) and that in use continued
compliance will be established by periodic tests carried out by, or on behalf of, the user.
Verification of cleaning efficacy is a key aspect of establishing satisfactory performance of a washer-
disinfector. The current state of knowledge has not permitted development of a single test method. As an
interim measure reference has been made to test methods which are currently being applied in a number of
different countries. The specification for these test methods including their test soils can be found in
ISO/TS 15883-5. It remains the intention of the Technical Committee of TC 198 to develop a single test
method.
In respect of the potential adverse effects on the quality of water intended for human consumption caused by
the washer-disinfector:
a) it should be noted that, until verifiable European criteria are adopted, existing national regulations
concerning the use and/or the characteristics of the washer-disinfector remain in force;
b) the ISO 15883 series of standards provides no information as to whether the washer-disinfector may be
used without restrictions in any of the member states of the EU or EFTA.
vi © ISO 2006 – All rights reserved

INTERNATIONAL STANDARD ISO 15883-1:2006(E)

Washer-disinfectors —
Part 1:
General requirements, terms and definitions and tests
1 Scope
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.
NOTE If it is considered that prion protein can be present, particular care is needed in the choice of disinfectants and
cleaning agents to ensure that the chemicals used do not react with the prion protein in a manner that may inhibit its
removal or inactivation.
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.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 228-1, Pipe threads where pressure-tight joints are not made on the threads — Part 1: Dimensions,
tolerances and designation
ISO 7000, Graphical symbols for use on equipment — Index and synopsis
ISO 15883-1:2006(E)
ISO 10012, Measurement management systems — Requirements for measurement processes and
measuring equipment
ISO 14644-3:2005, Cleanrooms and associated controlled environments — Part 3: Test methods
ISO 14971, Medical devices — Application of risk management to medical devices
ISO/TS 15883-5:2005, Washer-disinfectors — Part 5: Test soils and methods for demonstrating cleaning
efficacy
IEC 60417-DB, Graphical symbols for use on equipment
IEC 60584-1:1995, Thermocouples — Part 1: Reference tables
IEC 60751:1983, Industrial platinum resistance thermometer sensors
IEC 61010-2-045, Safety requirements for electrical equipment for measurement, control, and laboratory
use — Part 2-045: Particular requirements for washer disinfectors used in medical, pharmaceutical, veterinary
and laboratory fields
IEC 80416-1, Basic principles for graphical symbols for use on equipment — Part 1: Creation of symbol
originals
European Pharmacopeia, European Directorate for the Quality of Medicines, Council of Europe, Strasbourg,
France
United States Pharmacopeia, USP Pharmacopeia, Rockville, USA
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
A
equivalent time in seconds at 80 °C, delivered by the disinfection process, with reference to a microorganism
with a z value of 10 K
NOTE See Annex B.
3.2
automatic controller
device that, in response to pre-determined cycle variables, operates the apparatus sequentially through the
required stages of the process or processes
3.3
bedpan washer-disinfector
washer-disinfector intended to be used for the emptying, flushing, cleaning and thermal disinfecting of human
waste containers
3.4
bioburden
population of viable microorganisms on a product and/or its container
2 © ISO 2006 – All rights reserved

ISO 15883-1:2006(E)
3.5
calibration
set of operations that establish, under specified conditions, the relationship between values of a quantity
indicated by a measuring instrument or measuring system, or values represented by a material measure or a
reference material, and the corresponding values realized by standard
[EN 285:1996, definition 3.5]
3.6
calorifier
closed vessel, in which water is indirectly heated, by the flow of heated fluid through a heat exchanger, under
a pressure greater than atmospheric
3.7
chamber
that part of the washer-disinfector in which the load is processed
NOTE The chamber does not include steam generators, pipework, e.g. drain and fittings from which it can be isolated.
3.8
chemical disinfection
disinfection achieved by the action of one or more chemicals the primary purpose of which is to be
microbicidal
3.9
cleaning
removal of contamination from an item to the extent necessary for its further processing and its intended
subsequent use
3.10
continuous process machine
machine which automatically transports the load through each stage of the operating cycle
3.11
critical process variables
those process variables for which the values during an operating cycle have been identified by the
manufacturer as sufficient to ensure that the cycle meets the performance defined during validation
3.12
cycle complete
indication that the washing and disinfection cycle has been satisfactorily completed and that the disinfected
load is ready for removal from the chamber
3.13
cycle control recorder
a device which records the values of one or more control variables as seen by the automatic controller
3.14
D value
exposure time required under a defined set of conditions to cause a 1-logarithm or 90 % reduction in the
population of a particular microorganism
3.15
dead volume
volume of pipework which is not purged by the usual flow of liquids during the operating cycle
ISO 15883-1:2006(E)
3.16
disinfection
reduction of the number of viable microorganisms on a product to a level previously specified as appropriate
for its intended further handling or use
3.17
disinfection temperature
minimum temperature of the disinfection temperature band
3.18
disinfection temperature band
range of temperatures, expressed as the disinfection temperature (3.17) and the maximum allowable
temperature which may prevail throughout the load during the disinfection time
3.19
disinfection time
period for which the critical process variable(s) (e.g. temperature of the load, disinfectant concentration in the
chamber) are maintained at or above that specified for disinfection
3.20
door
device provided as a means of closing and sealing the chamber
3.21
double-ended washer-disinfector
washer-disinfector with separate doors for loading and unloading
3.22
endoscope washer-disinfector
washer-disinfector intended to clean and disinfect loads containing flexible endoscopes
3.23
fail safe
attribute of washer-disinfector design, or its associated services, that ensures that a single fault condition will
not give rise to a safety hazard
3.24
fault
recognition by the automatic controller that at least one of the pre-set process variables for the washer-
disinfector cycle have not been attained
3.25
fluid
liquid, gas or vapour
3.26
flushing
removal of gross contamination and/or the contents of a load item, but not necessarily contamination adhering
to the surface of the load item, by displacement with water
3.27
free draining
allowing the unimpeded flow of liquids under the influence of gravity towards the discharge point
3.28
holding time
period during which the critical process variables are maintained at or above the values specified
4 © ISO 2006 – All rights reserved

ISO 15883-1:2006(E)
3.29
human waste
excretions and body fluids including faeces, urine, blood, pus, vomit and mucus
3.30
human waste container
re-usable vessel for holding and transporting human waste
3.31
installation qualification
IQ
process of obtaining and documenting evidence that equipment has been provided and installed in
accordance with its specification
[ISO/TS 11139:2001, definition 2.20]
3.32
instrument washer-disinfector
washer-disinfector intended to clean and disinfect loads containing surgical instruments, anaesthetic
accessories, bowls, dishes, receivers, utensils, glassware and similar items
3.33
load
collective term used to describe all the goods, equipment and materials that are put into a washer-disinfector
at any one time for the purpose of cleaning and disinfecting it by an operating cycle
3.34
loading door
door in a double-ended washer-disinfector through which the load is put into the washer-disinfector prior to
processing
3.35
medical device
any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software,
material or other similar or relative article, intended by the manufacturer to be used, alone or in combination,
for human beings for one more of the specific purpose(s) of
⎯ diagnosis, prevention, monitoring, treatment, or alleviation of disease;
⎯ diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury;
⎯ investigation, replacement, modification or support of the anatomy or of a physiological process;
⎯ supporting or sustaining life;
⎯ control of conception;
⎯ disinfection of medical devices;
⎯ providing information for medical purposes by means of in vitro examination of specimens derived from
the human body,
and which does not achieve its primary intended action in or on the human body by pharmacological,
immunological or metabolic means, but which may be assisted in its function by such means
[ISO 13485:2003, definition 3.7]
ISO 15883-1:2006(E)
3.36
microbial reduction factor
extent to which the bioburden is reduced in tenfold increments expressed as logarithms (base 10)
3.37
monitoring
measurement of physical variables and comparison of the values obtained with the values specified for the
process
3.38
normal operation
operation of the washer-disinfector in accordance with the manufacturer’s instructions and with all process
parameters within the limits specified by the manufacturer
3.39
operating cycle
complete set of stages that is carried out in the sequence as regulated by the automatic controller
3.40
operating pressure
gauge pressure at which a vessel is operated during normal use
3.41
operational qualification
OQ
process of obtaining and documenting evidence that installed equipment operates within predetermined limits
when used in accordance with its operational procedures
[ISO/TS 11139:2001, definition 2.24]
3.42
override
system by which the operating cycle can be interrupted or modified as necessary
3.43
performance qualification
PQ
process of obtaining and documenting evidence that the equipment, as installed and operated in accordance
with operational procedures, consistently performs in accordance with predetermined criteria and thereby
yields product meeting its specification
[ISO/TS 11139:2001, definition 2.26]
NOTE The performance qualification for washer-disinfectors would concern the number of items cleaned and
disinfected to the required standard.
3.44
process chemical
formulation of chemical compounds intended for use in a washer-disinfector
NOTE Process chemicals include for example detergents, surfactants, rinse aids, disinfectants, enzymatic cleaners.
3.45
process variable
physical and chemical properties that influence the efficacy of all stages of the process
EXAMPLE Times, temperatures, disinfectant concentration, pressures and flows.
6 © ISO 2006 – All rights reserved

ISO 15883-1:2006(E)
3.46
process verification recorder
device that, independently of the automatic controller, records values obtained for some, or all, of the control
variables
3.47
recorder
system fitted to the washer-disinfector, or connected to the washer-disinfector, producing a permanent record
of information graphically, digitally or electronically
3.48
re-qualification
repeat of part or all of the validation test requirements for the purpose of confirming process reliability
3.49
rinsing
removal of process residues by displacement and dilution with water
3.50
routine test
periodic checking and testing carried out to establish that the operational performance of the washer-
disinfector remains within the limits established during validation
3.51
steam generator
vessel designed to contain water and a heating system (e.g. a steam coil or a fully immersed electric element)
which is used to heat water to its vapour state
3.52
tank
process vessel, integral to the washer-disinfector, designed to h
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