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CEN

EN 285:1996

(Main)

Sterilization - Steam sterilizers - Large sterilizers

Sterilization - Steam sterilizers - Large sterilizers

1.1 This European Standard specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of one or more sterilization modules for wrapped goods (instruments etc. and porous loads).   Large steam sterilizers can also be used during the commercial production of medical devices.   Note: Sterilizers conforming to this standard can offer a single automatic sterilization cycle or a number of selectable automatic sterilization cycles, e.g. with different operating temperatures (see 28.3b).  1.2 This European Standard is not applicable to small steam sterilizers nor to steam sterilizers used for the sterilization of pharmaceutical products in containers.  Note: The use of sterilizers for unwrapped instruments and utensils for immediate use in aseptic areas and for fluid-sterilizers will be the subject of a separate standards.  1.3 This European Standard does not describe a quality assurance system for the control of all stages of the manufacture of the sterilizer.  Note: Attention is drawn to the standards for quality systems (see EN ISO 9001, EN ISO 9002, EN ISO 9004-1 and EN 46001 and EN 46002).

Sterilisation - Dampf-Sterilisatoren - Groß-Sterilisatoren

Diese europäische Norm legt Anforderungen und entsprechende Prüfungen für Dampf-Groß-Sterilisatoren fest, die überwiegend im Gesundheitsdienst zur Sterilisation von einer oder mehreren Sterilisationseinheiten für verpackte Güter (Instrumente usw. und poröse Güter) verwendet werden. Dampf-Groß- Sterilisatoren können auch bei der gewerblichen Herstellung von Medizinprodukten verwendet werden. Anmerkung: Sterilisatoren entsprechend dieserNorm können einen einzelnen automatischen Sterilisationszyklus oder eine Anzahl wählbarer automatischer Sterilisationszyklen besitzen.

Stérilisation - Stérilisateurs à la vapeur d'eau - Grands stérilisateurs

La présente Norme européenne spécifie les exigences et les essais relatifs aux grands stérilisateurs à la vapeur d'eau utilisés essentiellement dans le domainede santé, pour la stérilisation d'une ou plusieurs unités de stérilisation pour produits emballés (instruments, charges poreuses, etc). Les grands stérilisateurs à la vapeur d'eau peuvent être également utilisés pour la production commerciale de dispositifs médicaux. Note: Les stérilisateurs conformes à la présente Norme peuvent présenter un cycle de stérilisation automatique unique...

Sterilizacija - Parni sterilizatorji - Veliki sterilizatorji

General Information

Status
Withdrawn
Publication Date
22-Oct-1996
Withdrawal Date
30-May-2006
ICS
11.080 - Sterilization and disinfection
Technical Committee
CEN/TC 102 - Sterilizers for medical purposes
Drafting Committee
CEN/TC 102/WG 2 - Testing
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
31-May-2006
Completion Date
31-May-2006
Directive
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
Ref Project
SIST EN 285:2000 - Sterilization - Steam sterilizers - Large sterilizers

Relations

Replaced By
EN 285:2006 - Sterilization - Steam sterilizers - Large sterilizers
Effective Date
22-Dec-2008
Corrected By
EN 285:1996/AC:1998 - Sterilization - Steam sterilizers - Large sterilizers
Effective Date
22-Dec-2008

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Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Sterilizacija - Parni sterilizatorji - Veliki sterilizatorjiSterilisation - Dampf-Sterilisatoren - Groß-SterilisatorenStérilisation - Stérilisateurs a la vapeur d'eau - Grands stérilisateursSterilization - Steam sterilizers - Large sterilizers11.080.10Sterilizacijska opremaSterilizing equipmentICS:Ta slovenski standard je istoveten z:EN 285:1996SIST EN 285:2000en01-januar-2000SIST EN 285:2000SLOVENSKI
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