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SIST EN 867-4:2001

(Main)

Non-biological systems for use in sterilizers - Part 4: Specification for indicators as an alternative to the Bowie and Dick test for the detection of steam penetration

Non-biological systems for use in sterilizers - Part 4: Specification for indicators as an alternative to the Bowie and Dick test for the detection of steam penetration

This European Standard specifies the performance requirements for a Class B indicator to be used as an alternative
to the Bowie and Dick test for steam sterilizers for wrapped goods (instruments etc. and porous loads). An indicator complying with this European Standard incorporates a specified material which is used as a test load. This test load may, or may not, be re-usable. This European standard does not specify requirements for the test load but specifies the performance of the indicator system in combination with the test load with which it is intended to be used. The indicator specified in this European standard is intended to identify poor steam penetration but does not indicate necessarily the cause of this poor steam penetration. The Bowie and Dick Test is performed to demonstrate conformance of a steam sterilizer for wrapped goods to EN 285 and may be used as a routine test of performance of such a sterilizer (see EN 554). The method of carrying out the test is described in EN 285. This European standard does not include test methods to establish the suitability of these indicators for use in sterilizers in which the air removal stage does not include evacuation below atmospheric pressure.

Nichtbiologische Systeme für den Gebrauch in Sterilisatoren -Teil 4: Festlegungen für Indikatoren, die alternativ zum Bowie-Dick- Test für den Nachweis der Dampfdurchdringung verwendet werden

Diese Europäische Norm legt die Leistungsanforderungen für einen Klasse B-Indikator fest, der alternativ zum
Bowie-Dick-Test in Dampfsterilisatoren für verpackte Waren (Instrumente usw. und poröse Ladungen) zu verwenden
ist.
Ein Indikator, der dieser Europäischen Norm entspricht, enthält ein festgelegtes Material, welches als Prüfladung
Diese Europäische Norm legt die Leistungsanforderungen für einen Klasse B-Indikator fest, der alternativ zum Bowie-Dick-Test in Dampfsterilisatoren für verpackte Waren (Instrumente usw. und poröse Ladungen) zu verwenden ist. Ein Indikator, der dieser Europäischen Norm entspricht, enthält ein festgelegtes Material, welches als Prüfladung verwendet wird. Diese Prüfladung kann zum einmaligen oder mehrmaligen Gebrauch vorgesehen sein. Diese Europäische Norm legt keine Anforderungen an die Prüfladung fest, sondern enthält Festlegungen zu der Leistungs-fähigkeit des Indikatorsystems in Verbindung mit der Prüfladung, mit der es zu verwenden ist. Der in dieser Europäischen Norm festgelegte Indikator dient dem Nachweis unzureichender Dampfdurchdringung, zeigt jedoch nicht unbedingt deren Ursache an. Der Bowie-Dick-Test wird sowohl zur Bestätigung der Konformität eines Dampfsterilisators für verpackte Sterilisier-güter mit EN 285 als auch zur Routineprüfung der Leistungsfähigkeit solcher Sterilisatoren (siehe EN 554) durch-geführt. Das Verfahren zur Durchführung der Prüfung wird in EN 285 beschrieben. Diese Europäische Norm enthält keine Prüfverfahren, um die Eignung dieser Indikatoren für den Gebrauch in Sterilisatoren festzulegen, in denen die Luftentfernungsstufe keine Evakuierung unter den Atmosphärendruck einschließt.

Systemes non-biologiques utilisés dans les stérilisateurs - Partie 4: Spécifications relatives aux indicateurs utilisés en alternative a l'essai de Bowie-Dick pour la détection de la pénétration de vapeur d'eau

Cette Norme européenne spécifie les exigences de performances qui s'appliquent a un indicateur de classe B servant d'alternative a l'essai de Bowie-Dick pour les stérilisateurs a la vapeur d'eau utilisés pour des objets enveloppés (instruments, etc. et charges poreuses). Un indicateur conforme a cette norme européenne comporte un matériau donné utilisé comme charge d'essai. Cette charge d'essai peut etre réutilisable ou non. Cette norme européenne ne spécifie pas d'exigences relatives a la charge d'essai, mais spécifie les performances du systeme d'indicateur combiné a la charge d'essai pour laquelle il est prévu. L'indicateur spécifié dans cette norme sert a identifier une mauvaise pénétration de vapeur d'eau, mais n'en indique pas nécessairement la cause. L'essai de Bowie-Dick vise a démontrer la conformité a l'EN 285 d'un stérilisateur a la vapeur d'eau pour des objets enveloppés et peut servir d'essai systématique de performances de ce stérilisateur (voir EN 554). La méthode d'essai est décrite dans l'EN 285. Cette Norme européenne ne couvre pas les méthodes d'essai visant a déterminer l'adéquation de ces indicateurs lorsqu'ils sont destinés a etre utilisés dans des stérilisateurs pour lesquels la phase d'extraction de l'air n'inclut pas l'évacuation sous pression atmosphérique.

Nebiološki sistemi za uporabo v sterilizatorjih - 4. del: Specifikacija drugih indikatorjev namesto Bowie-Dickovega preskusa za ugotavljanje prodiranja pare

General Information

Status
Withdrawn
Publication Date
31-Oct-2001
Withdrawal Date
13-Aug-2007
ICS
11.080.10 - Sterilizing equipment
Technical Committee
VAZ - Healthcare
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
14-Aug-2007
Due Date
06-Sep-2007
Completion Date
14-Aug-2007
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
EN 867-4:2000 - Non-biological systems for use in sterilizers - Part 4: Specification for indicators as an alternative to the Bowie and Dick test for the detection of steam penetration

Relations

Replaced By
SIST EN ISO 11140-4:2007 - Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration (ISO 11140-4:2007)
Effective Date
01-Sep-2007

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SLOVENSKI STANDARD
SIST EN 867-4:2001
01-november-2001
Nebiološki sistemi za uporabo v sterilizatorjih - 4. del: Specifikacija drugih
indikatorjev namesto Bowie-Dickovega preskusa za ugotavljanje prodiranja pare
Non-biological systems for use in sterilizers - Part 4: Specification for indicators as an
alternative to the Bowie and Dick test for the detection of steam penetration
Nichtbiologische Systeme für den Gebrauch in Sterilisatoren -Teil 4: Festlegungen für
Indikatoren, die alternativ zum Bowie-Dick- Test für den Nachweis der
Dampfdurchdringung verwendet werden
Systemes non-biologiques utilisés dans les stérilisateurs - Partie 4: Spécifications
relatives aux indicateurs utilisés en alternative a l'essai de Bowie-Dick pour la détection
de la pénétration de vapeur d'eau
Ta slovenski standard je istoveten z: EN 867-4:2000
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
SIST EN 867-4:2001 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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