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)

CMC - Renumber Annex ZC into Annex ZA

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• Status: Withdrawn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: 01-Mar-2005
• Withdrawal Date: 14-Oct-2009
• ICS: 11.080.01 - Sterilization and disinfection in general
• Technical Committee: CEN/TC 204 - Sterilization of medical devices
• Drafting Committee: CEN/TC 204 - Sterilization of medical devices
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 15-Oct-2009
• Completion Date: 15-Oct-2009
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
• Ref Project: SIST EN ISO 14937:2001/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)

Relations

• Replaces: EN ISO 14937:2000/AC:2003 - 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: 22-Dec-2008
• 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

Standards Content (Sample)

SLOVENSKI STANDARD
01-junij-2005
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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)
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)
Ta slovenski standard je istoveten z: EN ISO 14937:2000/AC:2005
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 14937:2000/AC
NORME EUROPÉENNE
March 2005
Mars 2005
EUROPÄISCHE NORM
März 2005
ICS 11.080.01
English version
Version Française
Deutsche Fassung
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)
Stérilisation des produits de santé - Sterilisation von Produkten für die
Exigences générales pour la caractérisation
...