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CEN

EN ISO 15883-6:2015

(Main)

Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO 15883-6:2011)

Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO 15883-6:2011)

ISO 15883-6:2011 specifies particular requirements for washer-disinfectors (WDs) intended for use when the level of assurance of disinfection that is necessary can be achieved by cleaning and thermal disinfection (A0 not less than 60) and does not require an independent automated record of critical processes to be kept. It is intended to be used in conjunction with ISO 15883-1, which gives general requirements for WDs.
The range of products on which WDs of this particular type can be used is restricted to devices and equipment which are non-invasive and non-critical (i.e. not penetrating skin or contacting mucosal surfaces).

Reinigungs-Desinfektionsgeräte - Teil 6: Anforderungen und Prüfverfahren für Reinigungs-Desinfektionsgeräte mit thermischer Desinfektion für nicht invasive, nicht kritische Medizinprodukte und Zubehör im Gesundheitswesen (ISO 15883-6:2011)

Der vorliegende Teil der ISO 15883 legt besondere Anforderungen an Reinigungs-Desinfektionsgeräte (RDG)
fest, die zur Verwendung vorgesehen sind, wenn der erforderliche Desinfektionssicherheitsgrad durch Reinigung
und thermische Desinfektion (A0 nicht unter 60) erreicht werden kann und es nicht erforderlich ist, eine
unabhängige automatisierte Aufzeichnung kritischer Prozesse aufzubewahren. Er soll zusammen mit
ISO 15883-1, welche allgemeine Anforderungen an RGD festlegt, angewendet werden.
Der Produktbereich, an dem RDG dieses Typs angewendet werden können, ist auf Produkte und Zubehör
beschränkt, die nicht invasiv und nicht kritisch sind (die d. h. nicht die Haut durchdringen oder Kontakt mit den
Schleimhautoberflächen haben).
ANMERKUNG Die thermische Desinfektion kann durch Spülen der Beladung mit heißem Wasser, durch Einwirkung
von Dampf oder durch eine Kombination aus Beidem erreicht werden.

Laveurs désinfecteurs - Partie 6: Exigences et essais pour les laveurs désinfecteurs utilisant une désinfection thermique pour les dispositifs médicaux non invasifs, non critiques et pour l'équipement de soins de santé (ISO 15883-6:2011)

L'ISO 15883-6:2011 spécifie les exigences particulières des laveurs désinfecteurs destinés à être utilisés lorsque le niveau d'assurance de désinfection nécessaire peut être obtenu par nettoyage et désinfection thermique (A0 au moins égal à 60) et ne nécessite pas que soit conservé un enregistrement automatique indépendant des procédés critiques. Elle est destinée à être utilisée conjointement à l'ISO 15883-1, qui donne des exigences générales pour les laveurs désinfecteurs.
La gamme de produits sur lesquels les laveurs désinfecteurs de ce type particulier peuvent être utilisés est limitée aux dispositifs et équipements non invasifs et non critiques (c'est-à-dire qui ne traversent pas la peau et qui ne sont pas en contact avec les muqueuses).

Čistilno-dezinfekcijske naprave - 6. del: Zahteve in preskusi čistilno-dezinfekcijskih naprav s toplotno dezinfekcijo za neinvazivne, nenujne medicinske pripomočke in zdravstveno opremo (ISO 15883-6:2011)

Standard ISO 15883-6:2011 določa posebne zahteve za čistilno-dezinfekcijske naprave (WD), ki so namenjene uporabi, ko je potrebno raven zagotavljanja dezinfekcije mogoče zagotoviti s čiščenjem in toplotno dezinfekcijo (A0 ne manj kot 60) ter ni potrebno neodvisno avtomatizirano shranjevanje kritičnih procesov. Standard je treba uporabljati v povezavi s standardom ISO 15883-1, ki določa splošne zahteve za čistilno-dezinfekcijske naprave.
Nabor izdelkov, pri katerih je mogoče uporabiti čistilno-dezinfekcijske naprave tega tipa, je omejen na neinvazivne in nenujne medicinske pripomočke ter zdravstveno opremo (tj. ne prodirajo skozi kožo ali se dotikajo sluznic).

General Information

Status
Published
Publication Date
18-Aug-2015
Withdrawal Date
28-Feb-2016
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
19-Aug-2015
Completion Date
19-Aug-2015
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 15883-6:2015 - Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO 15883-6:2011)

Relations

Replaces
EN ISO 15883-6:2011 - Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO 15883-6:2011)
Effective Date
12-Aug-2015

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 15883-6:2015
01-oktober-2015
1DGRPHãþD
SIST EN ISO 15883-6:2011
ýLVWLOQRGH]LQIHNFLMVNHQDSUDYHGHO=DKWHYHLQSUHVNXVLþLVWLOQR
GH]LQIHNFLMVNLKQDSUDYVWRSORWQRGH]LQIHNFLMR]DQHLQYD]LYQHQHQXMQHPHGLFLQVNH
SULSRPRþNHLQ]GUDYVWYHQRRSUHPR ,62
Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing
thermal disinfection for non-invasive, non-critical medical devices and healthcare
equipment (ISO 15883-6:2011)
Reinigungs-Desinfektionsgeräte - Teil 6: Anforderungen und Prüfverfahren für
Reinigungs-Desinfektionsgeräte mit thermischer Desinfektion für nicht invasive, nicht
kritische Medizinprodukte und Zubehör im Gesundheitswesen (ISO 15883-6:2011)
Laveurs désinfecteurs - Partie 6: Exigences et essais pour les laveurs désinfecteurs
utilisant une désinfection thermique pour les dispositifs médicaux non invasifs, non
critiques et pour l'équipement de soins de santé (ISO 15883-6:2011)
Ta slovenski standard je istoveten z: EN ISO 15883-6:2015
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
SIST EN ISO 15883-6:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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

SIST EN ISO 15883-6:2015

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

SIST EN ISO 15883-6:2015

EUROPEAN STANDARD
EN ISO 15883-6

NORME EUROPÉENNE

EUROPÄISCHE NORM
August 2015
ICS 11.080.10 Supersedes EN ISO 15883-6:2011
English Version
Washer-disinfectors - Part 6: Requirements and tests for
washer-disinfectors employing thermal disinfection for non-
invasive, non-critical medical devices and healthcare equipment
(ISO 15883-6:2011)
Laveurs désinfecteurs - Partie 6: Exigences et essais pour Reinigungs-Desinfektionsgeräte - Teil 6: Anforderungen
les laveurs désinfecteurs utilisant une désinfection und Prüfverfahren für Reinigungs-Desinfektionsgeräte mit
thermique pour les dispositifs médicaux non invasifs, non thermischer Desinfektion für nicht invasive, nicht kritische
critiques et pour l'équipement de soins de santé (ISO Medizinprodukte und Zubehör im Gesundheitswesen (ISO
15883-6:2011) 15883-6:2011)
This European Standard was approved by CEN on 4 August 2015.

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-CENELEC 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-CENELEC Management Centre has the same
status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15883-6:2015 E
worldwide for CEN national Members.

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

SIST EN ISO 15883-6:2015
EN ISO 15883-6:2015 (E)
Contents Page
European foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices .5
2

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

SIST EN ISO 15883-6:2015
EN ISO 15883-6:2015 (E)
European foreword
This document (EN ISO 15883-6:2015) has been prepared by Technical Committee ISO/TC 198 “Sterilization
of healthcare products” in collaboration with 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 February 2016, and conflicting national standards shall be withdrawn
at the latest by February 2016.
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
...

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