SIST EN ISO 15883-4:2008

SLOVENSKI STANDARD
SIST EN ISO 15883-4:2008
01-september-2008
ýLVWLOQRGH]LQIHNFLMVNHQDSUDYHGHO=DKWHYHLQSUHVNXVL]DþLVWLOQR
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Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing
chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008)
Reinigungs-Desinfektionsgeräte - Teil 4: Anforderungen und Prüfverfahren für
Reinigungs-Desinfektionsgeräte mit chemischer Desinfektion für thermolabile Endoskope
(ISO 15883-4:2008)
Laveurs désinfecteurs - Partie 4: Exigences et essais pour les laveurs désinfecteurs
destinés a la désinfection chimique des endoscopes thermolabiles (ISO 15883-4:2008)
Ta slovenski standard je istoveten z: EN ISO 15883-4:2008
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
SIST EN ISO 15883-4:2008 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 15883-4:2008

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SIST EN ISO 15883-4:2008
EUROPEAN STANDARD
EN ISO 15883-4
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2008
ICS 11.080.10

English Version
Washer-disinfectors - Part 4: Requirements and tests for
washer-disinfectors employing chemical disinfection for
thermolabile endoscopes (ISO 15883-4:2008)
Laveurs désinfecteurs - Partie 4: Exigences et essais pour Reinigungs-Desinfektionsgeräte - Teil 4: Anforderungen
les laveurs désinfecteurs destinés à la désinfection und Prüfverfahren für Reinigungs-Desinfektionsgeräte mit
chimique des endoscopes thermolabiles (ISO 15883- chemischer Desinfektion für thermolabile Endoskope (ISO
4:2008) 15883-4:2008)
This European Standard was approved by CEN on 21 April 2008.
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: rue de Stassart, 36  B-1050 Brussels
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15883-4:2008: E
worldwide for CEN national Members.

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SIST EN ISO 15883-4:2008
EN ISO 15883-4:2008 (E)
Contents Page
Foreword.3
Annex ZA (informative) Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices .4

2

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SIST EN ISO 15883-4:2008
EN ISO 15883-4:2008 (E)
Foreword
This document (EN ISO 15883-4:2008) 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 November 2008, and conflicting national standards shall be withdrawn
at the latest by November 2008.
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 EC Directive(s).
For relationship with EC Directive(s), see informative Annex ZA, B, C or D, 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.
3

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SIST EN ISO 15883-4:2008
EN ISO 15883-4:2008 (E)
Annex ZA
(informative)

Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices
By agreement between ISO and CEN, this CEN annex is included in the DIS and the FDIS but will not appear
in the published ISO standard.
This 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 International Standard and Directive 93/42/EEC on
medical devices
Clause(s)/sub-clause(s) of this
Essential Requirements (ERs) of Qualifying remarks/Notes
International Standard
Directive 93/42/EEC
4.1.1
1, 2, 3, 4, 5, 6, 7.1, 7.2, 7.3, 7.5, 7.6, The WD shall comply with the
8.1, 9.1, 9.2, 9.3, 12.1, 12.5, 12.6, requirements of ISO 15883-1:2006
12.7.1, 12.7.3, 12.7.5, 13.1, 13.3, 13.4,
13.6
4.1.2
1, 3, 4, 6, 7.1, 7.2, 7.5, 8.1, 9.1
4.1.3 1, 3, 4, 6, 7.1,7.2, 7.5, 8.1, 9.1
4.1.4 13.3 i), 13.3 k)
4.1.5 7.3, 8.1
7.3, 8.1
4.1.6
3, 7.3, 8.1, 9.1
4.1.7
4.1.8 13.4, 13.6 h), 13.3 k), 13.3 m)
4.2 3, 7.3, 7.5, 7.6, 8.1
4.3 3, 8.1
4.4 3, 8.1
4.5 3, 8.1
4.6 3, 8.1
4.7 3, 8.1
4.8 3, 9.1, 9.2
4.9 13.1, 13.6 d)
5.1 3, 9.1, 12.7.5
4

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SIST EN ISO 15883-4:2008
EN ISO 15883-4:2008 (E)
Table ZA.1 (continued)
Clause(s)/sub-clause(s) of this
Essential Requirements (ERs) of Qualifying remarks/Notes
International Standard
Directive 93/42/EEC
5.2 3, 8.1, 13.1
5.3 7.2, 7.5, 8.1
5.4 3, 8.1
5.5 3, 8.1
5.6 2, 3
6.2 1, 2, 3, 6, 7.1, 8.1 Testing for conformity
6.3 3, 9.1 Testing for conformity
6.4 3, 7.3, 8.1, 9.1 Testing for conformity
6.5 3, 7.5, 8.1, 9.1 Testing for conformity
6.6 3, 7.5, 8.1 Testing for conformity
6.7 3, 8.1 Testing for conformity
6.8 3, 8.1 Testing for conformity
6.9 3, 8.1 Testing for conformity
6.10 3, 8.1 Testing for conformity
6.11 3, 8.1 Testing for conformity
6.12 3, 8.1
7 13 The requirements of
ISO 15883-1:2006 apply.
8 13.1, 13.3, 13.4, 13.6 In addition, the requirements of
ISO 15883-1:2006 apply.
9 5, 13 The requirements of
ISO 15883-1:2006 apply.
10 1, 3 In addition, the requirements of
ISO 15883-1:2006 apply.

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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SIST EN ISO 15883-4:2008

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SIST EN ISO 15883-4:2008

INTERNATIONAL ISO
STANDARD 15883-4
First edition
2008-05-01


Washer-disinfectors —
Part 4:
Requirements and tests for washer-
disinfectors employing chemical
disinfection for thermolabile endoscopes
Laveurs désinfecteurs —
Partie 4: Exigences et essais pour les laveurs désinfecteurs destinés à
la désinfection chimique des endoscopes thermolabiles




Reference number
ISO 15883-4:2008(E)
©
ISO 2008

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SIST EN ISO 15883-4:2008
ISO 15883-4:2008(E)
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ii © ISO 2008 – All rights reserved

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SIST EN ISO 15883-4:2008
ISO 15883-4:2008(E)
Contents Page
Foreword. v
Introduction . vi
1 Scope . 1
2 Normative references . 2
3 Terms and definitions. 2
4 Performance requirements . 3
4.1 General. 3
4.2 Systems for leak testing . 4
4.3 Cleaning. 6
4.4 Disinfecting . 7
4.5 Final (post-disinfection) rinsing . 9
4.6 Purging to remove rinse water. 9
4.7 Drying. 9
4.8 Self-disinfection. 10
4.9 Water treatment equipment . 11
5 Mechanical and process requirements . 12
5.1 Materials ― Design, manufacture and construction. 12
5.2 Device channel irrigation system. 12
5.3 Venting and drainage systems. 13
5.4 Temperature control. 14
5.5 Process chemicals. 14
5.6 Process verification. 14
5.7 Dosing systems . 14
6 Testing for conformity. 14
6.1 General. 14
6.2 Test equipment . 15
6.3 Water used for final (post-disinfection) rinsing. 15
6.4 Hardness of water used during type testing. 15
6.5 Leak test . 16
6.6 Channels non-obstruction test. 18
6.7 Channels non-connection test . 19
6.8 Load dryness. 20
6.9 Thermometric tests. 20
6.10 Chemical dosing tests. 21
6.11 Tests of cleaning efficacy . 22
6.12 Test of disinfection efficacy . 23
7 Documentation and inspection . 27
8 Information to be supplied by the manufacturer. 27
9 Marking, labelling and packaging . 28
10 Information to be requested from the purchaser by the manufacturer . 28
Annex A (informative) Summary of activities covered by this Part of ISO 15883. 29
Annex B (normative) Microbiological testing of the efficacy of chemical disinfection of the load. 31
Annex C (informative) Summary of test programmes . 34
Annex D (normative) Methods for microbiological evaluation of disinfection of liquid transport
system. 35
© ISO 2008 – All rights reserved iii

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SIST EN ISO 15883-4:2008
ISO 15883-4:2008(E)
Annex E (normative) Tests for microbial contamination of post-disinfection rinse water. 40
Annex F (informative) Typical specifications of trumpet valves and connection ports. 41
Annex G (informative) Additional notes on microbiological testing of chemical disinfection
processes. 46
Bibliography . 48

iv © ISO 2008 – All rights reserved

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SIST EN ISO 15883-4:2008
ISO 15883-4:2008(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 15883-4 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
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
© ISO 2008 – All rights reserved v

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SIST EN ISO 15883-4:2008
ISO 15883-4:2008(E)
Introduction
It is recommended that this introduction be read in conjunction with the introduction to ISO 15883-1.
The washer-disinfectors specified in this part of ISO 15883 are intended to process devices which can be
immersed in water or aqueous solutions. For some devices this will require that, prior to processing, relevant
parts of the device are protected from immersion in accordance with the device manufacturer’s operating
instructions.
Fields of application within the scope of the 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.
Requirements for washer-disinfectors for other applications are specified in other parts of ISO 15883.
Safety requirements for washer-disinfectors are given in IEC 61010-2-040.
With respect to the potential adverse effects on the quality of water intended for human consumption caused
by the washer-disinfectors:
a) note that, until verifiable European criteria are adopted, existing national regulations concerning the use
and/or the characteristics of the washer-disinfectors remain in force;
b) this part of ISO 15883 provides no information as to whether the washer-disinfectors may be used without
restriction in any of the member states of the EU or EFTA.

vi © ISO 2008 – All rights reserved

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SIST EN ISO 15883-4:2008
INTERNATIONAL STANDARD ISO 15883-4:2008(E)

Washer-disinfectors —
Part 4:
Requirements and tests for washer-disinfectors employing
chemical disinfection for thermolabile endoscopes
1 Scope
This part of ISO 15883 specifies the particular requirements, including performance, for washer-disinfectors
(WDs) that are intended to be used for cleaning and chemical disinfection of thermolabile endoscopes.
This part of ISO 15883 also specifies the performance requirements for the cleaning and disinfection of the
washer-disinfector and its components and accessories which may be required to achieve the necessary
performance.
The methods, instrumentation and instructions required for type testing, works testing, validation (installation,
operational and performance qualification on first installation), routine control and monitoring and re-validation,
periodically and after essential repairs, are also specified.
NOTE 1 In addition, Annex A gives guidance on an appropriate division of responsibility for the range of activities
covered by this part of ISO 15883.
NOTE 2 WDs complying with this part of ISO 15883 can also be used for cleaning and chemical disinfection of other
thermolabile re-usable medical devices for which the device manufacturer has recommended this method of disinfection.
WDs complying with the requirements of this part of ISO 15883 are not intended for cleaning and disinfection
of medical devices, including endoscopic accessories, which are heat stable and can be disinfected or
sterilized by thermal methods (see ISO 15883-1:2006, 4.1.5).
The specified performance requirements of this part of ISO 15883 may not ensure the inactivation or removal
of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.
NOTE 3 If it is considered that prion protein might 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 from the load or washer-disinfector.
This part of ISO 15883 can be used by prospective purchasers and manufacturers as the basis of agreement
on the specification of WD manufacturers of endoscopes, cleaning products, disinfecting products, and also
by users.
© ISO 2008 – All rights reserved 1

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SIST EN ISO 15883-4:2008
ISO 15883-4:2008(E)
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 11731-2, Water quality — Detection and enumeration of Legionella — Part 2: Direct membrane filtration
method for waters with low bacterial counts
ISO 15883-1:2006, Washer-disinfectors — Part 1: General requirements, terms and definitions and tests
ISO/TS 15883-5:2005, Washer-disinfectors — Part 5: Test soils and methods for demonstrating cleaning
efficacy
IEC 61010-2-040, Safety requirements for electrical equipment for measurement, control, and laboratory
use ― Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical
materials
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 15883-1 and the following apply.
3.1
air break
physical separation in water supply pipes to prevent back syphonage into the water supply from a device
connected to it
NOTE See EN 1717.
3.2
inoculated carrier
supporting material on or in which a defined number of viable test organisms has been deposited
[ISO 11138-1:2006, definition 3.10]
3.3
leak test
test intended to establish that the surface covering the device and/or lining a device channel is intact to the
extent necessary to maintain a slightly positive pressure
3.4
liquid transport systems
those components of the washer-disinfector used to store, pump or transport water and/or solutions within the
washer-disinfector, excluding pipework before the air break
3.5
microbial inactivation factor
measured change in microbial population, expressed as log , caused by the lethal effect of the disinfectant
10
3.6
microbial reduction factor
measured change in microbial population expressed as log caused by the combination of the microbial
10
inactivation factor and the physical removal of microorganisms
3.7
obstruction
partial or complete blockage
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SIST EN ISO 15883-4:2008
ISO 15883-4:2008(E)
3.8
self-disinfection cycle
operating cycle under the control of the automatic controller, for use without any load in the washer-disinfector,
which is intended to disinfect all liquid transport systems’ piping, chamber(s), tanks and other components
which come into contact with the water and/or solutions used for cleaning, disinfecting and rinsing the load
NOTE This does not include disinfection of any pipework between the disinfectant supply and the control valve,
where single-use, multi-dose containers are used to provide process chemicals for use in the washer-disinfector.
3.9
thermolabile
damaged by exposure to temperatures within the range used for thermal disinfection
NOTE The minimum temperature for thermal disinfection specified in ISO 15883-1 is 65 °C.
4 Performance requirements
4.1 General
4.1.1 The WD shall conform to ISO 15883-1:2006 with the exception of the following subclauses:
⎯ 4.2.3 (washing stage);
⎯ 4.3.1 (specification for thermal disinfection);
⎯ 5.3.2.5 (microbial quality of final rinse water);
⎯ 6.4.2 (test for quality of final rinse water);
⎯ 6.5.6 (test for chamber venting to prevent pressurization by steam);
⎯ 6.7.2 (tests on trolleys for handling loads outside the WD);
⎯ 6.8.2 (load temperature test);
⎯ 6.10 (cleaning efficacy test; 6.10.2 modified by 6.11 of this part of ISO 15883).
NOTE These subclauses have been replaced or modified in this part of ISO 15883.
4.1.2 Each device, including any device channels and/or cavities, shall be processed by the WD as follows:
a) leak testing (where appropriate) in accordance with 4.2;
b) cleaning (which may include several stages) in accordance with 4.3;
c) disinfecting in accordance with 4.4;
d) final rinsing in accordance with 4.5;
e) purging of rinse water in accordance with 4.6;
f) drying (when appropriate) in accordance with 4.7.
© ISO 2008 – All rights reserved 3

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SIST EN ISO 15883-4:2008
ISO 15883-4:2008(E)
4.1.3 After the complete process in the WD the endoscope shall be free from vegetative bacteria (but not
necessarily spores) and other contamination. The combination of the cleaning process and the disinfection
process shall be designed to achieve this condition, recognising the high level of bacterial contamination that
may exist, see Bibliography [24], [25] and [26]. It shall be necessary to take into account other factors such as
the design of connectors. The WD manufacturer shall demonstrate this capability during type testing for all the
types of endoscope that the WD is designed to process.
NOTE 1 Demonstration of the capability of the complete cycle may be provided during type testing by employing a
modification of the method described in Annex B, using the organism previously established as most resistant to the
disinfectant, with real endoscope(s) and/or the method given in ISO/TS 15883-5:2005, Annex I.
NOTE 2 The efficacy of the process (including cleaning and disinfection) depends on a number of factors which include
a) the nature (characteristics) of the device being processed;
b) the extent and nature of the soiling to be removed;
c) the temperature;
d) the mechanical energy (type, output);
e) purging to remove rinse water;
f) the detergent system;
g) the nature, volume, concentration and temperature of the cleaning and disinfectant solu
...