SIST EN ISO 15883-2:2009
(Main)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)
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 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.
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 à la désinfection thermique des instruments chirurgicaux, du matériel d'anesthésie, des bacs, plats, récipients, ustensiles, de la verrerie, etc. (ISO 15883-2:2006)
L'ISO 15883-2:2006 spécifie les exigences particulières relatives aux laveurs désinfecteurs (LD) destinés à être utilisés pour le nettoyage et la désinfection thermique, au cours d'un seul cycle standard, des dispositifs médicaux réutilisables tels que les instruments chirurgicaux, le matériel d'anesthésie, les bacs, plats, récipients, ustensiles, de la verrerie, etc.
Les exigences de l'ISO 15883-2:2006 sont applicables conjointement avec les exigences générales spécifiées dans l'ISO 15883-1.
Les exigences de performances spécifiées dans l'ISO 15883-2:2006 peuvent ne pas assurer l'inactivation ou l'élimination de l'agent ou des agents infectieux (protéine du prion) des encéphalopathies spongiformes transmissibles.
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
Relations
Buy Standard
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 15883-2:2009
01-september-2009
1DGRPHãþD
SIST EN ISO 15883-2:2006
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 à 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 15883-2:2009
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
SIST EN ISO 15883-2:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 15883-2:2009
---------------------- Page: 2 ----------------------
SIST EN ISO 15883-2:2009
EUROPEAN STANDARD
EN ISO 15883-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2009
ICS 11.080.10 Supersedes EN ISO 15883-2:2006
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
laveurs désinfecteurs destinés à la désinfection thermique und Prüfverfahren von Reinigungs-Desinfektionsgeräten
des instruments chirurgicaux, du matériel d'anesthésie, des mit thermischer Desinfektion für chirurgische Instrumente,
bacs, plats, récipients, ustensiles, de la verrerie, etc. (ISO Anästhesiegeräte, Gefäße, Utensilien, Glasgeräte usw.
15883-2:2006) (ISO 15883-2:2006)
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 15883-2:2009: E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 15883-2:2009
EN ISO 15883-2:2009 (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 15883-2:2009
EN ISO 15883-2:2009 (E)
Foreword
The text of ISO 15883-2:2006 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
15883-2:2009 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 t
...
SLOVENSKI STANDARD
kSIST prEN ISO 15883-2:2009
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 à 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: prEN ISO 15883-2
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
kSIST prEN ISO 15883-2:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
kSIST prEN ISO 15883-2:2009
---------------------- Page: 2 ----------------------
kSIST prEN ISO 15883-2:2009
EUROPEAN STANDARD
FINAL DRAFT
prEN ISO 15883-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
January 2009
ICS 11.080.10 Will supersede EN ISO 15883-2:2006
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
laveurs désinfecteurs destinés à la désinfection thermique und Prüfverfahren von Reinigungs-Desinfektionsgeräten
des instruments chirurgicaux, du matériel d'anesthésie, des mit thermischer Desinfektion für chirurgische Instrumente,
bacs, plats, récipients, ustensiles de la verrerie, etc. (ISO Anästhesiegeräte, Gefäße, Utensilien, Glasgeräte usw.
15883-2:2006) (ISO 15883-2:2006)
This draft European Standard is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical
Committee CEN/TC 102.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
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. prEN ISO 15883-2:2009: E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
kSIST prEN ISO 15883-2:2009
prEN ISO 15883-2:2009 (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 ----------------------
kSIST prEN ISO 15883-2:2009
prEN ISO 15883-2:2009 (E)
Foreword
The text of ISO 15883-2:2006 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 prEN
ISO 15883-2:2009 by Technical Committee CEN/TC 102 “Sterilizers for medical purposes” the secretariat of
which is held by DIN.
This document is currently submitted to the Unique Acceptance Procedure.
This document will supersede EN ISO 15883-2:2006.
This document has been prepared under a mandate given to
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.