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SIST EN ISO 15883-1:2009
01-september-2009
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SIST EN ISO 15883-1:2006
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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
SIST EN ISO 15883-1:2009 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
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SIST EN ISO 15883-1:2009
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.
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SIST EN ISO 15883-1:2009
EN ISO 15883-1:2009 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
2
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SIST EN ISO 15883-1:2009
EN ISO 15883-1:2009 (E)
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.
3
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SIST EN ISO 15883-1:2009
EN ISO 15883-1:2009 (E)
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
4
1, 4, 3, 6, 7.1, 8.1, 9.1, 7.2, 9.2
2, 7.3
5.1
4
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
4
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SIST EN ISO 15883-1:2009
EN ISO 15883-1:2009 (E)
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
5
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SIST EN ISO 15883-1:2009
EN ISO 15883-1:2009 (E)
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.
6
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SIST EN ISO 15883-1:2009
EN ISO 15883-1:2009 (E)
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
7
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SIST EN ISO 15883-1:2009
EN ISO 15883-1:2009 (E)
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
8
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SIST EN ISO 15883-1:2009
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
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SIST EN ISO 15883-1:2009
ISO 15883-1:2006(E)
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ii © ISO 2006 – All rights reserved
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SIST EN ISO 15883-1:2009
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 2006 – All rights reserved iii
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SIST EN ISO 15883-1:2009
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
0
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
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SIST EN ISO 15883-1:2009
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 2006 – All rights reserved v
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SIST EN ISO 15883-1:2009
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 permit
...