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CEN

EN ISO 15883-3:2009

(Main)

Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006)

Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006)

ISO 15883-3:2006 specifies particular requirements for washer-disinfectors (WD) that are intended to be used for emptying, flushing, cleaning and thermal disinfection of containers used to hold human waste for disposal by one operating cycle.
ISO 15883-3:2006 is to be applied in conjunction with ISO 15883-1.

Reinigungs-Desinfektionsgeräte - Teil 3: Anforderungen an und Prüfverfahren für Reinigungs-Desinfektionsgeräten mit thermischer Desinfektion für Behälter für menschliche Ausscheidungen (ISO 15883-3:2006)

Dieser Teil von ISO 15883 legt besondere Anforderungen an Reinigungs-Desinfektionsgeräte (RDG) fest, die
für die Entleerung, Ausspülung, Reinigung und thermische Desinfektion von Behältern für menschliche
Ausscheidungen zur Behandlung innerhalb eines Betriebszyklus angewandt werden.
Die Anforderungen in diesem Teil gelten zusätzlich zu den in ISO 15883-1 festgelegten allgemeinen
Anforderungen.

Laveurs désinfecteurs - Partie 3: Exigences et essais pour laveurs désinfecteurs destinés à la désinfection thermique de récipients à déjections humaines (ISO 15883-3:2006)

L'ISO 15883-3:2006 spécifie les exigences particulières relatives aux laveurs désinfecteurs (LD) destinés à être utilisés pour vider, rincer, nettoyer et désinfecter thermiquement les récipients employés pour contenir les déjections humaines afin de pouvoir les réutiliser après un cycle standard.
L'ISO 15883-3:2006 s'applique conjointement avec l'ISO 15883-1.

Čistilno-dezinfekcijske naprave - 3. del: Zahteve in preskusi za čistilno-dezinfekcijske naprave s toplotno dezinfekcijo za zbiralnike človeških izločkov (ISO 15883-3:2006)

General Information

Status
Published
Publication 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
6060 - Definitive text made available (DAV) - Publishing
Start Date
03-Jun-2009
Completion Date
03-Jun-2009
Directive
2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
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 15883-3:2009 - Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006)

Relations

Replaces
EN ISO 15883-3:2006 - Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006)
Effective Date
06-Jun-2009
Revised
prEN ISO 15883-3 - Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO/DIS 15883‑3:2023)
Effective Date
18-Jan-2023

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 15883-3:2009
01-september-2009
1DGRPHãþD
SIST EN ISO 15883-3:2006
ýLVWLOQRGH]LQIHNFLMVNHQDSUDYHGHO=DKWHYHLQSUHVNXVL]DþLVWLOQR
GH]LQIHNFLMVNHQDSUDYHVWRSORWQRGH]LQIHNFLMR]D]ELUDOQLNHþORYHãNLKL]ORþNRY
,62
Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing
thermal disinfection for human waste containers (ISO 15883-3:2006)
Reinigungs-Desinfektionsgeräte - Teil 3: Anforderungen an und Prüfverfahren für
Reinigungs-Desinfektionsgeräten mit thermischer Desinfektion für Behälter für
menschliche Ausscheidungen (ISO 15883-3:2006)
Laveurs désinfecteurs - Partie 3: Exigences et essais pour laveurs désinfecteurs
destinés à la désinfection thermique de récipients à déjections humaines (ISO 15883-
3:2006)
Ta slovenski standard je istoveten z: EN ISO 15883-3:2009
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
SIST EN ISO 15883-3:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 15883-3:2009

---------------------- Page: 2 ----------------------

SIST EN ISO 15883-3:2009
EUROPEAN STANDARD
EN ISO 15883-3
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2009
ICS 11.080.10 Supersedes EN ISO 15883-3:2006
English Version
Washer-disinfectors - Part 3: Requirements and tests for
washer-disinfectors employing thermal disinfection for human
waste containers (ISO 15883-3:2006)
Laveurs désinfecteurs - Partie 3: Exigences et essais pour Reinigungs-Desinfektionsgeräte - Teil 3: Anforderungen an
laveurs désinfecteurs destinés à la désinfection thermique und Prüfverfahren für Reinigungs-Desinfektionsgeräten mit
de récipients à déjections humaines (ISO 15883-3:2006) thermischer Desinfektion für Behälter für menschliche
Ausscheidungen (ISO 15883-3:2006)
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 15883-3:2009: E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

SIST EN ISO 15883-3:2009
EN ISO 15883-3:2009 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

2

---------------------- Page: 4 ----------------------

SIST EN ISO 15883-3:2009
EN ISO 15883-3:2009 (E)
Foreword
The text of ISO 15883-3:2006 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
15883-3:2009 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 15883-3:2006.
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 A
...

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NOTE 3    If it is considered that prion protein might be present, particular care is needed in the choice of cleaning agents and disinfectants to ensure that the chemicals used do not react with the prion protein and/or other protein in a manner that can inhibit its removal or inactivation from the load or washer-disinfector.
NOTE 4    This document can be used by prospective purchasers and manufacturers as the basis of agreement on the specification of the WD, manufacturers of endoscopes, cleaning products, and disinfecting products.

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ISO 15883-1:2006 specifies general performance requirements for washer-disinfectors (WD) 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 can 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.
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