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CEN

EN 552:1994

(Main)

Sterilization of medical devices - Validation and routine control of sterilization by irradiation

Sterilization of medical devices - Validation and routine control of sterilization by irradiation

1.1 This European Standard specifies requirements for the validation, process control and monitoring of the radiation sterilization of medical devices. It is applicable to continuous and batch type gamma irradiators using the radionuclides 60Co or 137Cs and to irradiators using electrons, at or below an energy level of 10 MeV, generated from machine sources.  1.2 This European Standard specifies the requirements which ensure that a predetermined dose is consistently absorbed by product presented to the sterilization process.  1.3 This European Standard does not describe a quality assurance system for 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 stystem 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 covers the determination of the maximum dose but does not cover specifically the assessment of the suitability of a product for its intended use after radiation sterilization.  1.5 This European Standard does not cover radiation protection requirements associated with operating irradiation plants.  Note: Attention is drawn to the existence in some countries of national regulations laying down safety requirements when operating irradiation plants.

Sterilisation von Medizinprodukten - Validierung und Routineüberwachung für die Sterilisation mit Strahlen

Diese Europäische Norm legt die Anforderungen für die Validierung, Verfahrensregelung und- überwachung bei der Sterilisation von Medizinprodukten mit Strahlen fest. Sie ist anwendbar für kontinuierliche und chargenweise arbeitende Gammabestrahlungsanlagen, die die Radionuklide Co-60 oder Cs-137 verwenden und für Elektronen-Beschleunigeranlagen, die bei oder unter einem in der Anlage erzeugten Energieniveau von 10 MeV, arbeiten.

Stérilisation de dispositifs médicaux - Validation et contrôle de routine de la stérilisation par irradiation

La présente Norme Européenne spécifie les exigences concernant la validation, la maîtrise du procédé, et la surveillance de la stérilisation des dispositifs médicaux par irradiation. Elle est applicable aux irradiateurs gamma à fonctionnement continu et discontinu utilisant les radionucléides Co60 ou Cs137 et aux irradiateurs utilisant des électrons produits par des machines fonctionnant avec un niveau d'énergie maximale de 10 MeV.

Sterilizacija medicinskih pripomočkov - Validacija in redni nadzor sterilizacije z obsevanjem

General Information

Status
Withdrawn
Publication Date
29-Jun-1994
Withdrawal Date
14-Apr-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-Apr-2006
Completion Date
15-Apr-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 552:2000 - Sterilization of medical devices - Validation and routine control of sterilization by irradiation

Relations

Amended By
EN 552:1994/A1:1999 - Sterilization of medical devices - Validation and routine control of sterilization by irradiation
Effective Date
22-Dec-2008
Replaced By
EN ISO 11137-1:2006 - Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006)
Effective Date
22-Dec-2008
Amended By
EN 552:1994/A2:2000 - Sterilization of medical devices - Validation and routine control of sterilization by irradiation
Effective Date
22-Dec-2008
Replaced By
EN ISO 11137-3:2006 - Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects (ISO 11137-3:2006)
Effective Date
22-Dec-2008
Replaced By
EN ISO 11137-2:2006 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006)
Effective Date
22-Dec-2008

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 552:2000
01-januar-2000
6WHULOL]DFLMDPHGLFLQVNLKSULSRPRþNRY9DOLGDFLMDLQUHGQLQDG]RUVWHULOL]DFLMH]
REVHYDQMHP
Sterilization of medical devices - Validation and routine control of sterilization by
irradiation
Sterilisation von Medizinprodukten - Validierung und Routineüberwachung für die
Sterilisation mit Strahlen
Stérilisation de dispositifs médicaux - Validation et contrôle de routine de la stérilisation
par irradiation
Ta slovenski standard je istoveten z: EN 552:1994
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN 552:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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