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CEN

EN ISO 15883-1:2009/A1:2014

(Amendment)

Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006/Amd 1:2014)

Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006/Amd 1:2014)

2013-08-02 EMA: Draft for // vote received in ISO/CS (see notification of 2013-08-02 in dataservice).
2012-02-14 EMA: WI allocated to WG 8 as per TC secretary request.
2012-01-06 EMA: Draft for // ENQ received in ISO/CS (see notification of 2011-12-06 in dataservice).

Reinigungs-Desinfektionsgeräte - Teil 1: Allgemeine Anforderungen, Begriffe und Prüfverfahren (ISO 15883-1:2006/Amd 1:2014)

N/A

Laveurs désinfecteurs - Partie 1: Exigences générales, termes et définitions et essais (ISO 15883-1:2006/Amd 1:2014)

Čistilno-dezinfekcijske naprave - 1. del: Osnovne zahteve, termini, definicije in preskusi (ISO 15883-1:2006/Amd 1: 2014)

Določa zahteve za učinkovitost čiščenja in razkuževanja ter za pripomočke, ki jih je mogoče zahtevati za dosego želene učinkovitosti. Podane so tudi metode in instrumenti, potrebni za validacijo, rutinski nadzor ter nadzorovanje in vnovično validacijo, periodično in po nujnih popravilih. Zahteve za čistilno-razkuževalne naprave za obdelavo določenih polnjenj so podane v nadaljnjih delih tega standarda. Za čistilno-razkuževalne naprave za obdelavo polnjenj dveh ali več različnih tipov veljajo zahteve za vse ustrezne dele tega standarda. Ta del standarda ISO 15883 ne določa zahtev za stroje, ki se uporabljajo za pranje perila ali posebne namene v gostinstvu. Ta del standarda ISO 15883 ne vključuje zahtev za stroje, ki se uporabljajo za sterilizacijo polnjenja ali so načrtovani kot sterilizatorji. Te zahteve so podane v drugih standardih, npr. EN 285. Določene zahteve tega standarda morda ne zagotavljajo inaktivacije ali odstranitve vzročnih povzročiteljev (prionskih beljakovin) prenosljivih spongiformnih encefalopatij. Ta del standarda ISO 15883 lahko uporabljajo potencialni kupci in proizvajalci kot osnovo za dogovor o specifikaciji čistilno-razkuževalne naprave. Preskusne metode za prikaz skladnosti z zahtevami tega dela standarda ISO 15883 lahko uporabijo uporabniki za prikaz trajne skladnosti nameščene čistilno-razkuževalne naprave med življenjsko dobo delovanja. V dodatku A so podane smernice za rutinski program preskušanja.

General Information

Status
Published
Publication Date
15-Jul-2014
Withdrawal Date
30-Jan-2015
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
16-Jul-2014
Completion Date
16-Jul-2014
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 15883-1:2009/A1:2014 - Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006/Amd 1: 2014)

Relations

Amends
EN ISO 15883-1:2009 - Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006)
Effective Date
03-Sep-2011

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EN ISO 15883-1:2009/A1:2014EN ISO 15883-1:2009/A1:2014
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EN ISO 15883-1:2009/A1:2014
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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 15883-1:2009/A1:2014
01-oktober-2014
ýLVWLOQRGH]LQIHNFLMVNHQDSUDYHGHO2VQRYQH]DKWHYHWHUPLQLGHILQLFLMHLQ
SUHVNXVL ,62$PG
Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO
15883-1:2006/Amd 1: 2014)
Reinigungs-Desinfektionsgeräte - Teil 1: Allgemeine Anforderungen, Begriffe und
Prüfverfahren (ISO 15883-1:2006/Amd 1: 2014)
Laveurs désinfecteurs - Partie 1: Exigences générales, termes et définitions et essais
(ISO 15883-1:2006/Amd 1: 2014)
Ta slovenski standard je istoveten z: EN ISO 15883-1:2009/A1:2014
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
SIST EN ISO 15883-1:2009/A1:2014 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 15883-1:2009/A1:2014

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

SIST EN ISO 15883-1:2009/A1:2014

EUROPEAN STANDARD
EN ISO 15883-1:2009/A1

NORME EUROPÉENNE

EUROPÄISCHE NORM
July 2014
ICS 11.080.10
English Version
Washer-disinfectors - Part 1: General requirements, terms and
definitions and tests (ISO 15883-1:2006/Amd 1:2014)
Laveurs désinfecteurs - Partie 1: Exigences générales, Reinigungs-Desinfektionsgeräte - Teil 1: Allgemeine
termes et définitions et essais (ISO 15883-1:2006/Amd Anforderungen, Begriffe und Prüfverfahren (ISO 15883-
1:2014) 1:2006/Amd 1:2014)
This amendment A1 modifies the European Standard EN ISO 15883-1:2009; it was approved by CEN on 21 June 2014.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this
amendment into the relevant 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 amendment 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
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15883-1:2009/A1:2014 E
worldwide for CEN national Members.

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SIST EN ISO 15883-1:2009/A1:2014
EN ISO 15883-1:2009/A1:2014 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices .4

2

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

SIST EN ISO 15883-1:2009/A1:2014
EN ISO 15883-1:2009/A1:2014 (E)
Foreword
This document (EN ISO 15883-1:2009/A1:2014) has been prepared by Technical Committee ISO/TC 198
“Sterilization of health care products” in collaboration with Technical Committee CEN/TC 102 “Sterilizers for
medical purposes” the secretariat of which is held by DIN.
This Amendment to the European Standard EN ISO 15883:2009 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by January 2015, and
conflicting national standards shall be withdrawn at the latest by January 2015.
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 has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.
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, Fin
...

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