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SIST EN 867-2:2000

(Main)

Non-biological systems for use in sterilizers - Part 2: Process indicators (Class A)

Non-biological systems for use in sterilizers - Part 2: Process indicators (Class A)

This part of EN 867 specifies requirements for steam, ethylene oxide, irradiation, dry heat and steam/formaldehyde sterilisation process indicators intended for use with individual packs of product to demonstrate that the pack has been exposed to the process. They may be designed to react to one or more of the critical process variables but may be designed to achieve their end-point reaction after exposure to sub-optimal levels of the process variable. Process indicators have a defined end-point reaction.

Nichtbiologische Systeme für den Gebrauch in Sterilisatoren - Teil 2: Prozeßindikatoren (Klasse A)

Dieser Teil von EN 867 legt Anforderungen an Prozessindikatoren für die Sterilisation mit Dampf, Ethylenoxid, Bestrahlung, trockener Wärme und Dampf/Formaldehyd fest, die für einzelne Packungen des Produktes vorgesehen sind, um nachzuweisen, dass die Verpackung diesem Verfahren ausgesetzt wurde. Sie können auf eine oder mehrere der kritischen Prozessvoariablen reagieren, können jedoch auch ihre Endpunktreaktion nach Einwirkung von Pegeln unterhalb der optimalen Pegel der Prozessvariablen erreichen. Prozessindikatoren haben eine definierte Endpunktreaktion.

Systemes non-biologiques destinés a etre utilisés dans des stérilisateurs - Partie 2: Indicateurs de procédé (Class A)

La présente partie de la norme EN 867 spécifie les exigences pour les indicateurs pour la stérilisation a la vapeur d'eau, a l'oxyde d'éthylene, par rayonnement, a la chaleur seche et a la vapeur d'eau/au formaldéhyde. Ces indicateurs sont prévus pour etre utilisés avec des paquets isolés de produit, afin de montrer que le dit paquet a été exposé au procédé. Ils peuvent etre conçus pour réagir a une ou plusieurs des variables critiques de procédé, mais peuvent etre conçus pour réaliser leur réaction de point limita apres exposition a des niveaux sous-optimaux de la variable de procédé.

Nebiološki sistemi za uporabo v sterilizatorjih - 2. del: Indikatorji postopkov (razred A)

General Information

Status
Withdrawn
Publication Date
31-Dec-1999
Withdrawal Date
31-Oct-2005
ICS
11.080.10 - Sterilizing equipment
Technical Committee
VAZ - Healthcare
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
01-Nov-2005
Due Date
01-Nov-2005
Completion Date
01-Nov-2005
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 867-2:1997 - Non-biological systems for use in sterilizers - Part 2: Process indicators (Class A)

Relations

Replaced By
SIST EN ISO 11140-1:2005 - Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)
Effective Date
22-Dec-2008

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SLOVENSKI STANDARD
SIST EN 867-2:2000
01-januar-2000
Nebiološki sistemi za uporabo v sterilizatorjih - 2. del: Indikatorji postopkov
(razred A)
Non-biological systems for use in sterilizers - Part 2: Process indicators (Class A)
Nichtbiologische Systeme für den Gebrauch in Sterilisatoren - Teil 2: Prozeßindikatoren
(Klasse A)
Systemes non-biologiques destinés a etre utilisés dans des stérilisateurs - Partie 2:
Indicateurs de procédé (Class A)
Ta slovenski standard je istoveten z: EN 867-2:1997
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
SIST EN 867-2:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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