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- Withdrawn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
- 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
Relations
- Effective Date
- 22-Dec-2008
- Effective Date
- 22-Dec-2008
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Frequently Asked Questions
EN 866-2:1997 is a standard published by the European Committee for Standardization (CEN). Its full title is "Biological systems for testing sterilizers and sterilization processes - Part 2: Particular systems for use in ethylene oxide sterilizers". This standard covers: 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.
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.
EN 866-2:1997 is classified under the following ICS (International Classification for Standards) categories: 11.080 - Sterilization and disinfection. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 866-2:1997 has the following relationships with other standards: It is inter standard links to EN ISO 11138-2:2006, EN 866-2:1997/AC:1998. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 866-2:1997 is associated with the following European legislation: EU Directives/Regulations: 90/385/EEC; Standardization Mandates: M/BC/CEN/89/9. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN 866-2:1997 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo.
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