EN ISO 11138-1:2006

Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2006)

ISO 11138-1:2006 provides general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes.ISO 11138-1:2006 specifies basic and common requirements that are applicable to all subsequent parts of ISO 11138. Requirements for biological indicators for particular specified processes are provided in the subsequent parts of ISO 11138. If no specific subsequent part is provided, this part applies.

Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren - Teil 1: Allgemeine Anforderungen (ISO 11138-1:2006)

1.1   Allgemeines
1.1.1   Dieser Teil von ISO 11138 enthält allgemeine Anforderungen an die Herstellung, Kennzeichnung, Prüfverfahren und Leistungsmerkmale bei biologischen Indikatoren, einschließlich beimpfter Keimträger und Suspensionen und deren Bestandteilen, die bei der Validierung und Routineüberwachung von Sterilisations¬verfahren verwendet werden sollen.
1.1.2   Dieser Teil von ISO 11138 legt grundlegende und allgemeine Anforderungen fest, die für alle Folgeteile der ISO 11138 gelten. Anforderungen an biologische Indikatoren für besonders festgelegte Verfahren sind in den Folgeteilen der ISO 11138 enthalten. Wenn kein spezifischer Folgeteil erarbeitet wird, gilt dieser Teil.
ANMERKUNG   Nationale oder regionale Bestimmungen können gelten.
1.2   Nicht erfasste Gebiete
Dieser Teil der ISO 11138 gilt nicht für mikrobiologische Prüfsysteme für Verfahren, die auf der physikalischen Beseitigung von Mikroorganismen beruhen, z. B. Filtrationsverfahren oder Verfahren, bei denen die physikalische und/oder mechanische Keimentfernung mit einer mikrobiologischen Inaktivierung verbunden wird, wie bei der Anwendung von Wasch-Desinfektionsgeräten oder dem Durchspülen und Bedampfen von Leitungen. Dieser Teil der ISO 11138 könnte jedoch Elemente enthalten, die für solche mikrobiologischen Prüfsysteme von Bedeutung sind.

Stérilisation des produits de santé - Indicateurs biologiques - Partie 1: Exigences générales (ISO 11138-1:2006)

L'ISO 11138-1:2006 fournit les exigences générales relatives à la production, à l'étiquetage, aux méthodes d'essai et fournit les caractéristiques de performance des indicateurs biologiques, notamment les porte-germes inoculés et les suspensions et leurs composants, à utiliser dans la validation et la surveillance de routine des procédés de stérilisation.
L'ISO 11138-1:2006 spécifie les exigences fondamentales et communes applicables à toutes les autres parties de l'ISO 11138. Les exigences relatives aux indicateurs biologiques pour des procédés particuliers spécifiés sont précisées dans les autres parties de l'ISO 11138. En l'absence d'autre partie spécifique, la présente partie s'applique.

Sterilizacija izdelkov za zdravstveno nego - Biološki indikatorji - 1. del: Splošne zahteve (ISO 11138-1:2006)

General Information

• Status: Withdrawn
• Publication Date: 30-Jun-2006
• Withdrawal Date: 28-Mar-2017
• ICS: 11.080.01 - Sterilization and disinfection in general
• Technical Committee: CEN/TC 102 - Sterilizers for medical purposes
• Drafting Committee: CEN/TC 102 - Sterilizers for medical purposes
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 29-Mar-2017
• 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
• 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: SIST EN ISO 11138-1:2006 - Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2006)

Relations

• Replaces: EN 866-1:1997 - Biological systems for testing sterilizers and sterilization processes - Part 1: General requirements
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 11138-1:2017 - Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017)
• Effective Date: 13-May-2014

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11138-1:2006
01-september-2006
1DGRPHãþD
SIST EN 866-1:2000
Sterilizacija izdelkov za zdravstveno nego - Biološki indikatorji - 1. del: Splošne
zahteve (ISO 11138-1:2006)
Sterilization of health care products - Biological indicators - Part 1: General requirements
(ISO 11138-1:2006)
Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren - Teil 1:
Allgemeine Anforderungen (ISO 11138-1:2006)
Stérilisation des produits de santé - Indicateurs biologiques - Partie 1: Exigences
générales (ISO 11138-1:2006)
Ta slovenski standard je istoveten z: EN ISO 11138-1:2006
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 11138-1:2006 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11138-1:2006

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SIST EN ISO 11138-1:2006
EUROPEAN STANDARD
EN ISO 11138-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2006
ICS 11.080.01 Supersedes EN 866-1:1997
English Version
Sterilization of health care products - Biological indicators - Part
1: General requirements (ISO 11138-1:2006)
Stérilisation des produits de santé - Indicateurs biologiques Sterilisation von Produkten für die Gesundheitsfürsorge -
- Partie 1: Exigences générales (ISO 11138-1:2006) Biologische Indikatoren - Teil 1: Allgemeine Anforderungen
(ISO 11138-1:2006)
This European Standard was approved by CEN on 7 June 2006.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the Central Secretariat or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11138-1:2006: E
worldwide for CEN national Members.

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SIST EN ISO 11138-1:2006

EN ISO 11138-1:2006 (E)





Foreword


This document (EN ISO 11138-1:2006) has been prepared by Technical Committee ISO/TC 198
"Sterilization of health care products" in collaboration with Technical Committee CEN/TC 102
"Sterilizers for medical purposes", the secretariat of which is held by DIN.

This European Standard shall be given the status of a national standard, either by publication of
an identical text or by endorsement, at the latest by January 2007, and conflicting national
standards shall be withdrawn at the latest by January 2007.

This document supersedes EN 866-1:1997.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.


Endorsement notice

The text of ISO 11138-1:2006 has been approved by CEN as EN ISO 11138-1:2006 without any
modifications.

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SIST EN ISO 11138-1:2006


INTERNATIONAL ISO
STANDARD 11138-1
Second edition
2006-07-01

Sterilization of health care products —
Biological indicators —
Part 1:
General requirements
Stérilisation des produits de santé — Indicateurs biologiques —
Partie 1: Exigences générales




Reference number
ISO 11138-1:2006(E)
©
ISO 2006

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SIST EN ISO 11138-1:2006
ISO 11138-1:2006(E)
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