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CEN

EN 554:1994

(Main)

Sterilization of medical devices - Validation and routine control of sterilization by moist heat

Sterilization of medical devices - Validation and routine control of sterilization by moist heat

1.1 This European Standard specifies the requirements for the process development, validation, process control and monitoring of the sterilization of medical devices using moist heat.  1.2 The method is based on the monitoring of physical factors that cause the product to become sterile and presuppose that prior to validation the sterilizer and its installation comply with an appropriate specification.   Note: Specifications for sterilizers are being prepared by CEN/TC 102.  1.3 This European Standard does not describe a quality assurance system for the control of all stages of manufacture.   Note: Attention is drawn to the standards for quality systems (see EN 46001 or EN 46002) which control all stages of manufacture including the sterilization process. It is not a requirement of this standard to have a complete quality system during manufacture but certain elements of such a system are required and these are normatively referenced at appropriate places in the text.   1.4 This European Standard does not address the routine testing of samples (sterility testing) or the use of biological indicators as, except in a limited number of special applications, these practices are of limited value in moist heat sterilization. In such special applications, they should be regarded as additional to the measurement of physical parameters.

Sterilisation von Medizinprodukten - Validierung und Routineüberwachung für die Sterilisation mit feuchter Hitze

Diese europäische Norm legt die Anforderungen an die Verfahrensentwicklung, Validierung, Verfahrensregelung und Überwachung der Sterilisation von Medizin- produkten unter Verwendung von feuchter Hitze fest. Die Methode beruht auf der Überwachung der physikalischen Faktoren, die für die Sterilität des Produkts verantwortlich sind und setzt voraus, dass der Sterilisator und seine Installation vor der Validierung mit einer geeigneten Spezifikation übereinstimmen.

Stérilisation de dispositifs médicaux - Validation et contrôle de routine pour la stérilisation à la vapeur d'eau

La présente Norme Européenne spécifie les exigences concernant la mise au point, la  validation et le contrôle et la surveillance du procédé de stérilisation des dispositifs médicaux à la vapeur. La méthode utilisée repose sur le contôle des facteurs physiques qui entrainent la stérilité du produit et elle présuppose que, avant la validation, le stérilisateur et son installation soientconformes à une spécification appropriée.

Sterilizacija medicinskih pripomočkov - Validacija in redni nadzor sterilizacije z vlažno toploto

General Information

Status
Withdrawn
Publication Date
29-Jun-1994
Withdrawal Date
14-Aug-2006
ICS
11.080 - Sterilization and disinfection
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-Aug-2006
Completion Date
15-Aug-2006
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
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/BC/CEN/89/9 - Joint Standardization request to CEN/CENELEC concerning harmonized standards relating to horizontal aspects in the field of medical devices
Ref Project
SIST EN 554:2000 - Sterilization of medical devices - Validation and routine control of sterilization by moist heat

Relations

Replaced By
EN ISO 17665-1:2006 - Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)
Effective Date
22-Dec-2008

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 554:2000
01-januar-2000
6WHULOL]DFLMDPHGLFLQVNLKSULSRPRþNRY9DOLGDFLMDLQUHGQLQDG]RUVWHULOL]DFLMH]
YODåQRWRSORWR
Sterilization of medical devices - Validation and routine control of sterilization by moist
heat
Sterilisation von Medizinprodukten - Validierung und Routineüberwachung für die
Sterilisation mit feuchter Hitze
Stérilisation de dispositifs médicaux - Validation et contrôle de routine pour la stérilisation
a la vapeur d'eau
Ta slovenski standard je istoveten z: EN 554:1994
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN 554:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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