SIST EN ISO 15883-2:2009

SLOVENSKI STANDARD
01-september-2009
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SIST EN ISO 15883-2:2006
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Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing
thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes,
receivers, utensils, glassware, etc. (ISO 15883-2:2006)
Reinigungs-Desinfektionsgeräte - Teil 2: Anforderungen und Prüfverfahren von
Reinigungs-Desinfektionsgeräten mit thermischer Desinfektion für chirurgische
Instrumente, Anästhesiegeräte, Gefäße, Utensilien, Glasgeräte usw. (ISO 15883-2:2006)
Laveurs désinfecteurs - Partie 2: Exigences et essais pour laveurs désinfecteurs
destinés à la désinfection thermique des instruments chirurgicaux, du matériel
d'anesthésie, des bacs, plats, récipients, ustensiles, de la verrerie, etc. (ISO 15883-
2:2006)
Ta slovenski standard je istoveten z: EN ISO 15883-2:2009
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 15883-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2009
ICS 11.080.10 Supersedes EN ISO 15883-2:2006
English Version
Washer-disinfectors - Part 2: Requirements and tests for
washer-disinfectors employing thermal disinfection for surgical
instruments, anaesthetic equipment, bowls, dishes, receivers,
utensils, glassware, etc. (ISO 15883-2:2006)
Laveurs désinfecteurs - Partie 2: Exigences et essais pour Reinigungs-Desinfektionsgeräte - Teil 2: Anforderungen
laveurs désinfecteurs destinés à la désinfection thermique und Prüfverfahren von Reinigungs-Desinfektionsgeräten
des instruments chirurgicaux, du matériel d'anesthésie, des mit thermischer Desinfektion für chirurgische Instrumente,
bacs, plats, récipients, ustensiles, de la verrerie, etc. (ISO Anästhesiegeräte, Gefäße, Utensilien, Glasgeräte usw.
15883-2:2006) (ISO 15883-2:2006)
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 15883-2:2009: 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 15883-2:2006 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
15883-2:2009 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 15883-2:2006.
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 15883-2:2006 has been approved by CEN as a EN ISO 15883-2:2009 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 this Essential requirements (ERs) of EU 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, 8.1, 9.1, The WD shall comply with the
9.2, 9.3, 12.1, 12.5, 12.6, 12.7.1, 12.7.2, 12.7.3, requirements of ISO 15883-1:—
12.7.5, 13.1, 13.3, 13.4
4.1.2 1, 3, 4, 6, 7.1, 8.1, 9.1
4.1.3 1, 3, 4, 6, 7.1, 8.1, 9.1
4.1.5 3, 7.1
4.1.6 7.3, 8.1
4.2 3, 8.1
4.3 3, 8.1
4.4 3, 8.1
5.1 3, 8.1
5.2 3, 8.1
5.3 3, 8.1
6.1 1, 2, 3, 4, 7.1, 8.1 Testing for conformity according
to ISO 15883-1:—
6.2 3, 8.1
6.3 3, 8.1
7 9.1, 13.6
8 1, 3, 7.1, 7.2, 8.1
7.4, 8.2, 8.3, 8.4, 8.5, 8.6, 8.7, 10.1, 10.2, 10.3, not applicable
Clause 11, 12.2, 12.3, 12.4, 12.7.4, 12.8, 13.5,
- 12.1a) This relevant Essential
Requirement is not addressed in
this European Standard
4.1.1 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
4.1.1 1.1.7, 1.2.2, 1.2.3, 1.2.4, 1.2.5, This relevant EHSR are
1.3.2, 1.3.3, 1.3.4, 1.5.1, 1.5.2, addressed in this Standard
1.5.3, 1.5.5, 1.5.6, 1.5.8, 1.5.13,
1.5.14, 1.6.2, 1.6.3, 1.6.4, 1.6.5
4.1.1 1.1.3, 1.1.5, 1.1.6, 1.2.1, 1.2.6, This relevant EHSR are
1.3.1, 1.3.7, 1.3.8.1, 1.3.8.2, 1.5.4, partly addressed in this
1.6.1, 1.7.1, 1.7.2, ,1.7.3, 1.7.4 Standard
1.3.9, 1.4.1, 1.4.2, 1.4.3, 1.5.9, 4 This relevant EHSR are not
addressed in this Standard
INTERNATIONAL ISO
STANDARD 15883-2
First edition
2006-04-15
Washer-disinfectors —
Part 2:
Requirements and tests for washer-
disinfectors employing thermal
disinfection for surgical instruments,
anaesthetic equipment, bowls, dishes,
receivers, utensils, glassware, etc.
Laveurs désinfecteurs —
Partie 2: Exigences et essais pour laveurs désinfecteurs destinés à la
désinfection thermale des instruments chirurgicaux, du matériel
d'anesthésie, des récipients, des ustensiles et de la verrerie, etc.

Reference number
ISO 15883-2:2006(E)
©
ISO 2006
ISO 15883-2:2006(E)
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ii © ISO 2006 – All rights reserved

ISO 15883-2:2006(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references. 1
3 Terms and definitions. 2
4 Performance requirements . 2
4.1 General. 2
4.2 Cleaning. 3
4.3 Disinfecting. 3
4.4 Temperature of internal surfaces of processed devices. 4
5 Mechanical and control requirements. 4
5.1 Load connectors . 4
5.2 Control systems. 5
5.3 Process verification. 5
6 Testing for conformity. 5
6.1 General. 5
6.2 Tests for soil removal from chamber walls, load carrier and load . 5
6.3 Thermometric tests. 6
7 Information to be supplied by the manufacturer. 8
8 Information to be requested from the purchaser by the supplier of the WD. 8
Annex A (informative) Summary of test programmes . 9
Bibliography . 10

ISO 15883-2:2006(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 15883-2 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]
iv © ISO 2006 – All rights reserved

ISO 15883-2:2006(E)
Introduction
It is recommended that this Introduction be read in conjunction with the introduction to ISO 15883-1:2006.
This part of ISO 15883 is the second of a series of standards specifying the performance of washer-
disinfectors and specifies the general requirements for performance applicable to instrument washer-
disinfectors. The requirements given in this part apply to washer-disinfectors used for cleaning and thermal
disinfection of medical devices intended for re-use such as:
⎯ surgical instruments;
⎯ powered devices;
⎯ instrument trays;
⎯ instruments for minimally invasive surgery;
⎯ lumen devices and tubing;
⎯ rigid endoscopes;
⎯ anaesthetic and respiratory equipment;
⎯ bowls, dishes and receivers;
⎯ glassware;
⎯ containers for transit.
Fields of application within the scope of the ISO 15883 series of standards 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 the ISO 15883
series of standards.
When processed in the instrument washer-disinfector, the medical devices might be intended for immediate
use or might be intended for packing and sterilization. In both cases, the efficacy of the cleaning and
disinfection is of major importance. In either case, this is for the well being of the patient. In the latter case, it is
also for the safety of the staff who handles the instruments in the process of inspection, testing and packing as
well as ensuring that the sterilization process is not unduly challenged by residual soil.
The efficacy of disinfection can be impaired if soil removal is incomplete before the start of the disinfection
process. Users should be aware that some medical devices might require pre-treatment e.g. soaking,
brushing, ultra sonic pre-cleaning, lumen irrigation or any combination of these techniques. Reference should
be made to the medical manufacturer's instructions for reprocessing (see also ISO 17664).
Safety requirements for washer-disinfectors are given in IEC 61010-2-045.
ISO 15883-2:2006(E)
In respect of the potential adverse effects on the quality of water intended for human consumption caused by
the washer-disinfectors:
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-disinfectors remain in force;
b) the ISO 15883 series of standards 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 2006 – All rights reserved

INTERNATIONAL STANDARD ISO 15883-2:2006(E)

Washer-disinfectors —
Part 2:
Requirements and tests for washer-disinfectors employing
thermal disinfection for surgical instruments, anaesthetic
equipment, bowls, dishes, receivers, utensils, glassware, etc.
1 Scope
This part of ISO 15883 specifies particular requirements for washer-disinfectors (WD) that are intended for
use for the cleaning and thermal disinfection, in a single operating cycle, of re-usable medical devices such as
surgical instruments, anaesthetic equipment, bowls, dishes and receivers, utensils and glassware.
NOTE 1 Thermal disinfection can be achieved by rinsing the load with hot water, exposure to steam or combination of
the two.
The requirements specified in this part of ISO 15883 are applicable in conjunction with the general
requirements specified in ISO 15883-1.
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 2 If it is considered that prion protein can be present, particular care is needed in
...