EN ISO 15883-2:2006

SLOVENSKI STANDARD
01-julij-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 a 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 15883-2:2006
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
April 2006
ICS 11.080.10
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 an
laveurs désinfecteurs destinés à la désinfection thermale und Prüfungen von Reinigungs-Desinfektionsgeräten mit
des instruments chirurgicaux, du matériel d'anesthésie, des thermischer Desinfektion für chirurgische Instrumente,
récipients, des ustensiles et de la verrerie, etc. (ISO 15883- Anästhesiegeräte, Gefäße, Utensilien, Glasgeräte usw.
2:2006) (ISO 15883-2:2006)
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 15883-2:2006: E
worldwide for CEN national Members.

Foreword
This document (EN ISO 15883-2:2006) 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.

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
International Standard of EU 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,
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of 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
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