SIST EN ISO 15883-1:2006

SLOVENSKI STANDARD
SIST EN ISO 15883-1:2006
01-julij-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 15883-1:2006
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
SIST EN ISO 15883-1:2006 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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EUROPEAN STANDARD
EN ISO 15883-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2006
ICS 11.080.10

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, Definitionen und Prüfungen (ISO 15883-
1:2006)
This European Standard was approved by CEN on 16 March 2006.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, 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: rue de Stassart, 36  B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15883-1:2006: E
worldwide for CEN national Members.

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EN ISO 15883-1:2006 (E)





Foreword


This document (EN ISO 15883-1:2006) has been prepared by Technical Committee CEN/TC 102
"Sterilizers for medical purposes", the secretariat of which is held by DIN, in collaboration with
Technical Committee ISO/TC 198 "Sterilization of health care products".

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 October 2006, and conflicting national standards
shall be withdrawn at the latest by October 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 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, 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.

2

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EN ISO 15883-1:2006 (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 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 this Essential requirements (ERs) Qualifying remarks/Notes
European Standard of EU Directive 93/42/EEC

4 1, 4, 3, 6, 7.1, 8.1, 9.1, 7.2, 9.2
5.1 2, 7.3
5.1.3 4
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, The WD shall comply with the
9.1, 9.2, 9.3, 12.5, 12.6, 12.7.1, requirements of IEC 61010-2-045
12.7.2, 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
3

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EN ISO 15883-1:2006 (E)

Table ZA.1 (continued)

Clauses/subclauses of this Essential requirements (ERs) Qualifying remarks/Notes
European Standard of EU Directive 93/42/EEC

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
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
4

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EN ISO 15883-1:2006 (E)


Table ZA.1 (continued)

Clauses/subclauses of this Essential requirements (ERs) Qualifying remarks/Notes
European Standard 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
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.

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

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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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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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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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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

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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
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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
0
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

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ISO 15883-1:2006(E)
3.5
calibration
set of operations that establish, under specified condit
...