EN ISO 14937:2000

SLOVENSKI STANDARD
SIST EN ISO 14937:2001
01-november-2001
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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
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.
...