EN ISO 15883-1:2006

Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006)

This part of EN ISO 15883 specifies general performance requirements for washer-disinfectors 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 may 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.

Reinigungs-Desinfektionsgeräte - Teil 1: Allgemeine Anforderungen, Begriffe und Prüfverfahren (ISO 15883-1:2006)

Dieser Teil von ISO 15883 legt allgemeine Leistungsanforderungen an Reinigungs-Desinfektionsgeräte (RDG) und deren Zubehör fest, die für die Reinigung und Desinfektion wieder verwendbarer Medizinprodukte und anderer in der medizinischen, zahnmedizinischen, pharmazeutischen und veterinärmedizinischen Praxis verwendeter Artikel vorgesehen sind. Sie legt die Leistungsanforderungen für die Reinigung und Desinfektion sowie für das Zubehör fest, die zum Erreichen der erforderlichen Leistung notwendig sein können. Ebenso werden die Verfahren und Messgeräte festgelegt, die für die Validierung, die Routineüberprüfung sowie, Routineüberwachung und die Revalidierung, die in periodischen Abständen und nach wesentlichen Reparaturen erfolgt, benötigt werden.
Die Anforderungen an die zur Behandlung spezifischer Beladungsgüter bestimmten RDG sind in folgenden Teilen dieser Norm festgelegt. Für Reinigungs-Desinfektionsgeräte, die für die Behandlung von zwei oder mehreren Arten von Beladungsgütern bestimmt sind, gelten die Anforderungen aller sie betreffenden Teile dieser Norm.
Dieser Teil von ISO 15883 legt keine Anforderungen für Geräte fest, die für die Anwendung in Wäschereien oder im Bereich der Lebensmittelzubereitung bestimmt sind.
Dieser Teil von ISO 15883 enthält keine Anforderungen an Geräte, die für die Sterilisation der Beladung bestimmt sind oder als „Sterilisatoren“ bezeichnet werden; diese sind in anderen Normen, z. B. EN 285, festgelegt.
Es ist möglich, dass die in dieser Norm festgelegten Leistungsanforderungen nicht die Inaktivierung oder Beseitigung von Erregern übertragbarer spongiformer Enzephalopathien (Prionenproteine) sicherstellen können.

Laveurs désinfecteurs - Partie 1: Exigences générales, termes et définitions et essais (ISO 15883-1:2006)

Čistilno-dezinfekcijske naprave - 1. del: Osnovne zahteve, termini, definicije in preskusi (ISO 15883-1:2006)

General Information

• Status: Withdrawn
• Publication Date: 14-Apr-2006
• Withdrawal Date: 02-Jun-2009
• ICS: 11.080.10 - Sterilizing equipment
• Technical Committee: CEN/TC 102 - Sterilizers for medical purposes
• Drafting Committee: CEN/TC 102/WG 8 - Performance requirements and testing for washer-disinfectors
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 03-Jun-2009
• Completion Date: 03-Jun-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: SIST EN ISO 15883-1:2006 - Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006)

Relations

• Splited From: prEN ISO 15883-1 - Washer-disinfectors - Part 1: General requirements, definitions and tests (ISO/DIS 15883-1:2003)
• Effective Date: 08-Mar-2023
• Replaced By: EN ISO 15883-1:2009 - Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006)
• Effective Date: 22-Dec-2008

Standards Content (Sample)

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 medica
...