SIST EN ISO 15883-2:2006

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)

This part of prEN ISO 15883 specifies particular requirements for washer disinfectors (WD) that are intended to be used for the cleaning and thermal disinfection, in a single operating cycle, of re-usable medical devices such as surgical instruments, anaesthetic equipment, hollowware, utensils and glassware.
NOTE   Thermal disinfection may be achieved by rinsing the load with hot water, exposure to steam or combination of the two.
The requirements in this part apply in addition to the general requirements specified in prEN ISO 15883-1:2002.

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)

Dieser Teil von ISO 15883 legt besondere Anforderungen an Reinigungs-Desinfektionsgeräte (RDG) fest, die für die Reinigung und thermische Desinfektion wieder verwendbarer medizinischer Produkte  wie chirurgische Instrumente, Anästhesiezubehör/-materialien, Schüsseln, Schalen, Auffanggefäße, Utensilien und Glaswaren  in einem einzigen Prozessablauf  bestimmt sind.
ANMERKUNG 1   Die thermische Desinfektion kann durch Spülen der Beladung mit heißem Wasser, die Einwirkung von Dampf oder Kombination beider erreicht werden.
Die Anforderungen in diesem Teil von ISO 15883 gelten zusätzlich zu den in ISO 15883 1 festgelegten allgemeinen Anforderungen.
Die in diesem Teil von ISO 15883 festgelegten Leistungsanforderungen können nicht die Inaktivierung oder Beseitigung von Erregern übertragbarer Spongiformer Enzephalopathien (Prionenproteine) sicherstellen.
ANMERKUNG 2   Wenn daran zu denken ist, dass Prionenproteine vorhanden sein können, ist bei der Wahl der Desinfektions  und Reinigungsmittel besondere Sorgfalt erforderlich, um sicherzustellen, dass die verwendeten Chemikalien nicht mit dem Prionenprotein auf eine Weise reagieren, die dessen Beseitigung oder Inaktivierung verhindern kann.

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)

La présente partie du prEN ISO 15883 détermine les exigences spécifiques pour les laveurs-désinfecteurs destinés a etre utilisés pour nettoyer et désinfecter thermiquement, au cours d'un seul cycle standard, les dispositifs médicaux réutilisables tels que les instruments chirurgicaux, le matériel d'anesthésie, les articles de faience, les ustensiles et la verrerie.
NOTE   La désinfection thermique peut etre effectuée en rinçant la charge a l'eau chaude, en l'exposant a la vapeur ou par combinaison de ces deux méthodes.
Les exigences de cette partie s'ajoutent a celles spécifiées dans le prEN ISO 15883 1:2002.

Čistilno-dezinfekcijske naprave - 2. del: Zahteve in preskusi za čistilno-dezinfekcijske naprave s toplotno dezinfekcijo za kirurške instrumente, anestezijsko opremo, posode idr. (ISO 15883-2:2006)

General Information

• Status: Withdrawn
• Publication Date: 30-Jun-2006
• Withdrawal Date: 06-Jul-2009
• ICS: 11.080.10 - Sterilizing equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 07-Jul-2009
• Due Date: 30-Jul-2009
• Completion Date: 07-Jul-2009
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN ISO 15883-2:2006 - 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)

Relations

• Replaced By: SIST EN ISO 15883-2:2009 - 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)
• Effective Date: 01-Sep-2009

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 15883-2:2006
01-julij-2006
ýLVWLOQRGH]LQIHNFLMVNHQDSUDYHGHO=DKWHYHLQSUHVNXVL]DþLVWLOQR
GH]LQIHNFLMVNHQDSUDYHVWRSORWQRGH]LQIHNFLMR]DNLUXUãNHLQVWUXPHQWH
DQHVWH]LMVNRRSUHPRSRVRGHLGU,62
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
SIST EN ISO 15883-2:2006 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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EUROPEAN STANDARD
EN ISO 15883-2
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.

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EN ISO 15883-2:2006 (E)




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.

2

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EN ISO 15883-2:2006 (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
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,
14
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.

3

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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

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

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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 2006 – All rights reserved iii

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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

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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 2006 – All rights reserved v

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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

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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 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.
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 4017, Hexagon head screws — Product grades A and B
ISO 5356-2, Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-
bearing connectors
ISO 5361, Anaesthetic and respiratory equipment — Tracheal tubes and connectors
ISO 5362, Anaesthetic reservoir bags
ISO 5367, Breathing tubes intended for use with anaesthetic apparatus and ventilators
ISO 15883-1:2006, Washer-disinfectors — Part 1: General requirements, definitions and tests
ISO 17664, Sterilization of medical devices — Information to be provided by the manufacturer for the
processing of resterilizable medical devices
© ISO 2006 – All rights reserved 1

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ISO 15883-2:2006(E)
ISO/TS 15883-5:2005, Washer-disinfectors — Part 5: Test soils and methods for demonstrating cleaning
efficacy
EN 10088-2, Stainless steels — Part 2: Technical delivery conditions for sheet/plate and strip for general
purposes
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 15883-1
...