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CEN

prEN ISO 15883-2

(Main)

Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices (ISO/DIS 15883-2:2023)

Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices (ISO/DIS 15883-2:2023)

ISO 15883-2:2006 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.
The requirements in ISO 15883-2:2006 apply in addition to the general requirements specified in ISO 15883-1.
The specified performance requirements of ISO 15883-2:2006 may not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.

Reinigungs-Desinfektionsgeräte - Teil 2: Anforderungen und Prüfverfahren von Reinigungs-Desinfektionsgeräten mit thermischer Desinfektion für kritische und semikritische Medizinprodukte (ISO/DIS 15883-2:2023)

Dieses Dokument legt besondere Anforderungen an Reinigungs-Desinfektionsgeräte (RDG) fest, die für die Reinigung und thermische Desinfektion wiederverwendbarer Medizinprodukte wie chirurgische Instrumente, Anästhesiegeräte, Schüsseln, Schalen, Auffanggefäße, Utensilien und Glaswaren in einem einzigen Prozessablauf bestimmt sind.
Die in diesem Dokument festgelegten Anforderungen gelten zusätzlich zu den in ISO/DIS 15883 1:2020 festgelegten allgemeinen Anforderungen.
Die in diesem Dokument festgelegten Leistungsanforderungen stellen die Inaktivierung oder die Beseitigung des (der) verursachenden Agens (Agenzien) (Prionenproteine) von transmissiblen spongiformen Enzephalopathien möglicherweise nicht sicher.

Laveurs désinfecteurs - Partie 2: Exigences et essais pour laveurs désinfecteurs destinés à la désinfection thermique des dispositifs médicaux critiques et semi-critiques (ISO/DIS 15883-2:2023)

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 kritične in polkritične medicinske pripomočke (ISO/DIS 15883-2:2023)

General Information

Status
Not Published
Publication Date
24-Nov-2024
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
4599 - Dispatch of FV draft to CMC - Finalization for Vote
Start Date
22-Mar-2024
Completion Date
22-Mar-2024
Directive
2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
Mandate
M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
Ref Project
oSIST prEN ISO 15883-2:2023 - Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices (ISO/DIS 15883-2:2023)

Relations

Revises
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
18-Jan-2023

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SLOVENSKI STANDARD
oSIST prEN ISO 15883-2:2023
01-julij-2023
Čistilno-dezinfekcijske naprave - 2. del: Zahteve in preskusi za čistilno-
dezinfekcijske naprave s toplotno dezinfekcijo za kritične in polkritične
medicinske pripomočke (ISO/DIS 15883-2:2023)
Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing
thermal disinfection for critical and semi-critical medical devices (ISO/DIS 15883-2:2023)
Reinigungs-Desinfektionsgeräte - Teil 2: Anforderungen und Prüfverfahren von
Reinigungs-Desinfektionsgeräten mit thermischer Desinfektion für kritische und
semikritische Medizinprodukte (ISO/DIS 15883-2:2023)
Laveurs désinfecteurs - Partie 2: Exigences et essais pour laveurs désinfecteurs
destinés à la désinfection thermique des dispositifs médicaux critiques et semi-critiques
(ISO/DIS 15883-2:2023)
Ta slovenski standard je istoveten z: prEN ISO 15883-2
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
oSIST prEN ISO 15883-2:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 15883-2:2023

---------------------- Page: 2 ----------------------
oSIST prEN ISO 15883-2:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 15883-2
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
2023-04-24 2023-07-17
Washer-disinfectors —
Part 2:
Requirements and tests for washer-disinfectors employing
thermal disinfection for critical and semi-critical medical
devices
ICS: 11.080.10
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 15883-2:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

---------------------- Page: 3 ----------------------
oSIST prEN ISO 15883-2:2023
ISO/DIS 15883-2:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 15883-2
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:

Washer-disinfectors —
Part 2:
Requirements and tests for washer-disinfectors employing
thermal disinfection for critical and semi-critical medical
devices
ICS: 11.080.10
This document is circulated as received from the committee secretariat.
COPYRIGHT PROTECTED DOCUMENT
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: +41 22 749 01 11
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: copyright@iso.org
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 15883-2:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
  © ISO 2023 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

---------------------- Page: 4 ----------------------
oSIST prEN ISO 15883-2:2023
ISO/DIS 15883-2:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope .
...

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