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EN ISO 15883-5:2021

(Main)

Washer-disinfectors - Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy (ISO 15883-5:2021)

Washer-disinfectors - Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy (ISO 15883-5:2021)

This document specifies procedures and test methods used to demonstrate the cleaning efficacy of washer-disinfectors (WD) and their accessories intended to be used for cleaning of reusable medical devices.
NOTE 1   The requirements can be used for washer-disinfectors intended for use with other articles used in the context of medical, dental, laboratory, pharmaceutical and veterinary practice.
NOTE 2   This document does not apply to the activities to be performed by the manufacturers of reusable medical devices.

Reinigungs-Desinfektionsgeräte - Teil 5: Leistungsanforderungen und Kriterien für Prüfverfahren zum Nachweis der Reinigungswirksamkeit (ISO 15883-5:2021)

Dieses Dokument legt Verfahren und Prüfmethoden fest, die zum Nachweis der Reinigungswirksamkeit von Reinigungs-Desinfektionsgeräten (RDG) und ihres Zubehörs, die für die Reinigung von wiederverwendbaren Medizinprodukten eingesetzt werden, angewendet werden sollen.
ANMERKUNG 1 Die Anforderungen können auf Reinigungs-Desinfektionsgeräte angewendet werden, die zur Verwendung mit anderen Gegenständen bestimmt sind, die im Rahmen der medizinischen, zahnmedizinischen, labortechnischen, pharmazeutischen und veterinärmedizinischen Praxis verwendet werden.
ANMERKUNG 2 Dieses Dokument ist nicht anzuwenden für die Tätigkeiten, die von den Herstellern von wiederverwendbaren Medizinprodukten durchzuführen sind.

Laveurs désinfecteurs - Partie 5: Exigences de performance et critères des méthodes d’essai pour démontrer l’efficacité du nettoyage (ISO 15883-5:2021)

Le présent document spécifie les modes opératoires et les méthodes d’essai utilisés pour démontrer l’efficacité du nettoyage des laveurs désinfecteurs (LD) ainsi que de leurs accessoires destinés à être utilisés pour nettoyer des dispositifs médicaux réutilisables.
NOTE 1      Les exigences peuvent être utilisées pour les laveurs désinfecteurs destinés à être utilisés avec d’autres articles utilisés dans le contexte d’activités médicales, dentaires,laboratoires,  pharmaceutiques et vétérinaires.
NOTE 2      Le présent document ne s’applique pas aux activités à effectuer par les fabricants de dispositifs médicaux réutilisables.

Čistila - 5. del: Zahtevane lastnosti in merila preskusnih metod za prikaz učinka čiščenja (ISO 15883-5:2021)

General Information

Status
Published
Publication Date
17-Aug-2021
Withdrawal Date
27-Feb-2022
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
18-Aug-2021
Completion Date
18-Aug-2021
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
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 15883-5:2021 - Washer-disinfectors - Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy (ISO 15883-5:2021)

Relations

Replaces
CEN ISO/TS 15883-5:2005 - Washer-disinfectors - Part 5: Test soils and methods for demonstrating cleaning efficacy (ISO/TS 15883-5:2005)
Effective Date
25-Aug-2021

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 15883-5:2021
01-oktober-2021
Nadomešča:
SIST-TS CEN ISO/TS 15883-5:2006
Čistila - 5. del: Zahtevane lastnosti in merila preskusnih metod za prikaz učinka
čiščenja (ISO 15883-5:2021)
Washer-disinfectors - Part 5: Performance requirements and test method criteria for
demonstrating cleaning efficacy (ISO 15883-5:2021)
Reinigungs-Desinfektionsgeräte - Teil 5: Leistungsanforderungen und Kriterien für
Prüfverfahren zum Nachweis der Reinigungswirkung (ISO 15883-5:2021)
Laveurs désinfecteurs - Partie 5: Exigences de performance et critères des méthodes
d’essai pour démontrer l’efficacité du nettoyage (ISO 15883-5:2021)
Ta slovenski standard je istoveten z: EN ISO 15883-5:2021
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
SIST EN ISO 15883-5:2021 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 15883-5:2021

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SIST EN ISO 15883-5:2021


EN ISO 15883-5
EUROPEAN STANDARD

NORME EUROPÉENNE

August 2021
EUROPÄISCHE NORM
ICS 11.080.10 Supersedes CEN ISO/TS 15883-5:2005
English Version

Washer-disinfectors - Part 5: Performance requirements
and test method criteria for demonstrating cleaning
efficacy (ISO 15883-5:2021)
Laveurs désinfecteurs - Partie 5: Exigences de Reinigungs-Desinfektionsgeräte - Teil 5:
performance et critères des méthodes d'essai pour Leistungsanforderungen und Kriterien für
démontrer l'efficacité du nettoyage (ISO 15883- Prüfverfahren zum Nachweis der Reinigungswirkung
5:2021) (ISO 15883-5:2021)
This European Standard was approved by CEN on 28 February 2021.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, 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: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15883-5:2021 E
worldwide for CEN national Members.

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SIST EN ISO 15883-5:2021
EN ISO 15883-5:2021 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 15883-5:2021
EN ISO 15883-5:2021 (E)
European foreword
This document (EN ISO 15883-5:2021) has been prepared by Technical Committee ISO/TC 198
"Sterilization of health care products" in collaboration with Technical Committee CEN/TC 102
“Sterilizers and associated equipment for processing of medical devices” 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 2022, and conflicting national standards
shall be withdrawn at the latest by February 2022.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes CEN ISO/TS 15883-5:2005.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN websites.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North
...

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