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)

Migrated from Progress Sheet (TC Comment) (2000-07-10): Contact Mr Vyze ext 850 when processing this project through each stage

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)

1.1 Diese Internationale Norm legt die allgemeinen Anforderungen an die Charakterisierung eines Sterilisiermittels sowie die Entwicklung, Validierung und Routineüberwachung eines Sterilisationsverfahrens für Medizinprodukte fest. Anmerkung: Obwohl der Anwendungsbereich dieser Norm auf Medizinprodukte beschränkt ist, können die beschriebenen Prinzipien auch auf andere Produkte für die Gesundheitsfürsorge angewendet werden. Diese Norm ersetzt oder modifiziert keine bereits veröffentliche Norm für besondere Sterilisationsverfahren.

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• Status: Withdrawn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: 14-Dec-2000
• 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/WG 9 - General requirements for sterilization
• 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
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 14937:2001 - 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

• 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
• Corrected By: 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
• Corrected 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

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 14937:2001
01-november-2001
6WHULOL]DFLMDL]GHONRY]D]GUDYVWYHQRQHJR6SORãQH]DKWHYH]DRSUHGHOLWHY
ODVWQRVWLVWHULOL]DFLMVNLKVUHGVWHYLQ]DUD]YRMYDOLGDFLMRWHUUXWLQVNRNRQWUROR
VWHULOL]DFLMVNLKSRVWRSNRY]DPHGLFLQVNHSULSRPRþNH,62
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
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 14937:2001 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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INTERNATIONAL ISO
STANDARD 14937
First edition
2000-12-15
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
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
Reference number
ISO 14937:2000(E)
©
ISO 2000

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ISO 14937:2000(E)
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ISO 14937:2000(E)
Contents Page
Foreword.v
Introduction.vi
1 Scope .1
2 Normative references .1
3 Terms and definitions .2
4 Quality system elements.5
4.1 General.5
4.2 Assignment of responsibilities .5
4.3 Documentation and records.5
4.4 Design control.
...