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CEN

EN 866-2:1997

(Main)

Biological systems for testing sterilizers and sterilization processes - Part 2: Particular systems for use in ethylene oxide sterilizers

Biological systems for testing sterilizers and sterilization processes - Part 2: Particular systems for use in ethylene oxide sterilizers

This part of EN 866 specifies requirements for inoculated carriers and biological indicators intended for use in assessing the performance of sterilizers employing ethylene oxide gas as the sterilant. These are intended for use in sterilizers employing pure ethylene oxide gas or admixtures of the gas with diluent gases, over a sterilizing temperature range of 20°C to 65°C.

Biologische Systeme für die Prüfung von Sterilisatoren und Sterilisationsverfahren - Teil 2: Spezielle Systeme für den Gebrauch in Ethylenoxid-Sterilisatoren

Dieser Teil von EN 866 legt die Anforderungen an beimpfte Keimträger und biologische Indikatoren fest, die für die Beurteilung der Leistungsfähigkeit von Sterilisatoren mit Ethylenoxidgas als Sterilisiermittel vorgesehen sind. Sie sind für Sterilisatoren bestimmt, bei denen reines Ethylenoxidgas oder Mischungen des Gases mit Verdünnungsgasen bei Sterilisiertemperaturen von 20° C bis 65°C verwendet wird.

Systèmes biologiques pour l'essai des stérilisateurs et les procédés de stérilisation - Partie 2: Systèmes particuliers destinés à être utilisés dans des stérilisateurs à l'oxyde d'éthylène

La présente partie de l'EN 866 spécifie les exigences pour les porte-germes inoculés et les indicateurs biologiques dont l'utilisation est prévue pour l'évaluation de la performance de stérilisateurs employant de l'oxyde d'éthylène gazeux comme agent de stérilisation. Leur utilisation est prévu dans des stérilisateurs employant de l'oxyde pur d'éthylène gazeux ou des mélanges avec des gaz diluant, sur une plage de température de stérilisation comprise entre 20°C et 65°C.

Biološki sistemi za preskušanje sterilizatorjev in sterilizacijskih postopkov – 2. del: Posebni sistemi za uporabo sterilizacije z etilenoksidom

General Information

Status
Withdrawn
Publication Date
18-Feb-1997
Withdrawal Date
30-Jun-2006
ICS
11.080 - Sterilization and disinfection
Technical Committee
CEN/TC 102 - Sterilizers for medical purposes
Drafting Committee
CEN/TC 102/WG 7 - Biological and chemical indicators
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
01-Jul-2006
Completion Date
01-Jul-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
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 866-2:2000 - Biological systems for testing sterilizers and sterilization processes - Part 2: Particular systems for use in ethylene oxide sterilizers

Relations

Corrected By
EN 866-2:1997/AC:1998 - Biological systems for testing sterilizers and sterilization processes - Part 2: Particular systems for use in ethylene oxide sterilizers
Effective Date
22-Dec-2008
Replaced By
EN ISO 11138-2:2006 - Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006)
Effective Date
22-Dec-2008

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 866-2:2000
01-januar-2000
Biološki sistemi za preskušanje sterilizatorjev in sterilizacijskih postopkov – 2. del:
Posebni sistemi za uporabo sterilizacije z etilenoksidom
Biological systems for testing sterilizers and sterilization processes - Part 2: Particular
systems for use in ethylene oxide sterilizers
Biologische Systeme für die Prüfung von Sterilisatoren und Sterilisationsverfahren - Teil
2: Spezielle Systeme für den Gebrauch in Ethylenoxid-Sterilisatoren
Systemes biologiques pour l'essai des stérilisateurs et les procédés de stérilisation -
Partie 2: Systemes particuliers destinés a etre utilisés dans des stérilisateurs a l'oxyde
d'éthylene
Ta slovenski standard je istoveten z: EN 866-2:1997
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN 866-2:2000 en
2003-01.Slovenski inštitut za standardizacijo.
...

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