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EN ISO 14937:2000/AC:2003

(Corrigendum)

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2000)

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2000)

ISO - Taking over of an ISO Technical Corrigendum

Sterilisation von Produkten für die Gesundheitsfürsorge - Allgemeine Anforderungen an die Charakterisierung eines Sterilisiermittels und an die Entwicklung, Validierung und Routineüberwachung eines Sterilisationsverfahrens für Medizinprodukte (ISO 14937:2000)

Stérilisation des produits de santé - Exigences générales pour la caractérisation d'un agent stérilisant et pour le développement, la validation et la vérification de routine d'un processus de stérilisation pour dispositifs médicaux (ISO 14937:2000)

Sterilizacija izdelkov za zdravstveno nego - Splošne zahteve za opredelitev lastnosti sterilizacijskih sredstev in za razvoj, validacijo ter rutinsko kontrolo sterilizacijskih postopkov za medicinske pripomočke (ISO 14937:2000)

General Information

Status
Withdrawn
Publication Date
16-Dec-2003
Withdrawal Date
01-Mar-2005
ICS
11.080.01 - Sterilization and disinfection in general
Technical Committee
CEN/TC 204 - Sterilization of medical devices
Drafting Committee
CEN/TC 204/WG 9 - General requirements for sterilization
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
02-Mar-2005
Completion Date
02-Mar-2005
Ref Project
SIST EN ISO 14937:2001/AC:2004 - Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2000)

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Corrects
EN ISO 14937:2000 - Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2000)
Effective Date
08-Jun-2022
Replaced By
EN ISO 14937:2009 - Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)
Effective Date
17-Oct-2009
Replaced By
EN ISO 14937:2000/AC:2005 - Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2000)
Effective Date
08-Jun-2022

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EN ISO 14937:2001/AC:2004EN ISO 14937:2001/AC:2004
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EN ISO 14937:2001/AC:2004
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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.SUHGHOLWHYSterilisation von Produkten für die Gesundheitsfürsorge - Allgemeine Anforderungen an die Charakterisierung eines Sterilisiermittels und an die Entwicklung, Validierung und Routineüberwachung eines Sterilisationsverfahrens für Medizinprodukte (ISO 14937:2000)Stérilisation des produits de santé - Exigences générales pour la caractérisation d'un agent stérilisant et pour le développement, la validation et la vérification de routine d'un processus de stérilisation pour dispositifs médicaux (ISO 14937:2000)Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2000)11.080.01Sterilizacija in dezinfekcija na splošnoSterilization and disinfection in generalICS:Ta slovenski standard je istoveten z:EN ISO 14937:2000/AC:2003SIST EN ISO 14937:2001/AC:2004en01-februar-2004SIST EN ISO 14937:2001/AC:2004SLOVENSKI
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SIST EN ISO 14937:2001/AC:2004



EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 14937:2000/ACDecember 2003Décembre 2003Dezember 2003ICS: 11.080.01English versionVersion FrançaiseDeutsche FassungSterilization of health care products - General requirements forcharacterization of a sterilizing agent and the development,validation and routine control of a sterilization process formedical devices (ISO 14937:2000)Stérilisation des produits de santé - Exigences générales pour lacaractérisation d'un agent stérilisant et pour le développement, lavalidation et la vérification de routine d'un processus destérilisation pour dispositifs médicaux (ISO 14937:2000)Sterilisation von Produkten für die Gesundheitsfürsorge -Allgemeine Anforderungen an die Charakterisierung einesSterilisiermittels und an die Entwicklung, Validierung undRoutineüberwachung eines Sterilisationsverfahrens fürMedizinprodukte (ISO 14937:2000)This corrigendum becomes effective on 17 December 2003 for incorporation in the three officiallanguage versions of the EN.Ce corrigendum prendra effet le 17 décembre 2003 pour incorporation dans les trois versionslinguistiques officielles de l'EN.Die Berichtigung tritt am 17. Dezember 2003 zur Einarbeitung in die drei offiziellen Sprachfassungender EN in Kraft.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2003 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members.Tous droits d'exploitation sous quelque forme et de quelque manière que ce soit réservés dans le monde entier auxmembres nationaux du CEN.Alle Rechte der Verwertung, gleich in welcher Form und in welchem Verfahren, sind w
...

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1.1.1    This document specifies requirements for the development, validation and routine control of a low temperature steam and formaldehyde (LTSF) sterilization process for medical devices using a mixture of low temperature steam and formaldehyde as sterilizing agent and which operates below ambient pressure.
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1.1.2    This document is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized and the organizations with responsibility for sterilizing medical devices (see ISO 14937:2009, Table E.1).
1.2    Exclusions
1.2.1    This document does not specify requirements for the development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.
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1.2.4    This document does not specify requirements for occupational safety associated with the design and operation of LTSF sterilization facilities.
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