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EN 866-1:1997

(Main)

Biological systems for testing sterilizers and sterilization processes - Part 1: General requirements

Biological systems for testing sterilizers and sterilization processes - Part 1: General requirements

This part of EN 866 specifies general requirements for the manufacture of biological systems to be used in testing sterilizers. The requirements of this part of EN 866 apply to all biological systems specified in subsequent Parts of EN 866, unless the requirement is modified or added to by a subsequent Part, in which case the requirement of the particular Part will apply.

Biologische Systeme für die Prüfung von Sterilisatoren und Sterilisationsverfahren - Teil 1: Allgemeine Anforderungen

Dieser Teil von EN 866 legt die allgemeinen Anforderungen an die Herstellung biologischer Systeme fest, die bei der Prüfung von Sterilisatoren zu verwenden sind. Die Anforderungen dieses Teils von EN 866 gelten für alle biologischen Systeme, die in den weiteren Teilen der EN 866 aufgeführt werden. Es sei denn, die Anforderung wurde durch einen nachfolgenden Teil verändert oder ergänzt. In diesem Fall glt die Anforderung des bestimmten Teils.

Systèmes biologiques pour l'essai des stérilisateurs et les procédés de stérilisation - Partie 1: Exigences générales

La présente partie de la norme EN 866 spécifie les exigences générales pour la fabrication de systèmes biologiques destinés à être utilisés pour l'essai des stérilisateurs. Les exigences de la présente partie de l'EN 866 s'appliquent à tous les systèmes biologiques spécifiés dans d'autres parties de cette norme européenne, sauf si l'exigence est modifiée ou complétée par une autre partie, auquel cas c'est l'exigence de cette dernière partie qui sera applicable.

Biološki sistemi za preskušanje sterilizatorjev in sterilizacijskih postopkov – 1. del: Splošne zahteve

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Withdrawn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 866-1:2000 - Biological systems for testing sterilizers and sterilization processes - Part 1: General requirements

Relations

Replaced By
EN ISO 11138-1:2006 - Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2006)
Effective Date
22-Dec-2008

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SLOVENSKI STANDARD
SIST EN 866-1:2000
01-januar-2000
Biološki sistemi za preskušanje sterilizatorjev in sterilizacijskih postopkov – 1. del:
Splošne zahteve
Biological systems for testing sterilizers and sterilization processes - Part 1: General
requirements
Biologische Systeme für die Prüfung von Sterilisatoren und Sterilisationsverfahren - Teil
1: Allgemeine Anforderungen
Systemes biologiques pour l'essai des stérilisateurs et les procédés de stérilisation -
Partie 1: Exigences générales
Ta slovenski standard je istoveten z: EN 866-1:1997
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN 866-1:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 866-1:2000

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SIST EN 866-1:2000

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SIST EN 866-1:2000

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SIST EN 866-1:2000
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