EN ISO 11138-4:2017

Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2017)

2016-12-13: Decision 458 on de-harmonization of EN ISO 11138 series taken on 2016-12-09.

Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren - Teil 4: Biologische Indikatoren für Sterilisationsverfahren mit trockener Hitze (ISO 11138-4:2017)

Dieses Dokument legt spezifische Anforderungen an Prüfkeime, Suspensionen, beimpfte Keimträger, biologische Indikatoren und Prüfverfahren fest, die für die Anwendung bei der Beurteilung der Leistung von Sterilisationsverfahren vorgesehen sind, die trockene Hitze als sterilisierendes Agens bei Sterilisiertemperaturen im Bereich von 120 °C bis 180 °C anwenden.
ANMERKUNG 1   Anforderungen an die Validierung und Überwachung von Sterilisationsverfahren mit trockener Hitze sind in ISO 20857 angegeben.
ANMERKUNG 2   Anforderungen an die Sicherheit am Arbeitsplatz können in nationalen oder regionalen Bestimmungen festgelegt sein.

Stérilisation des produits de santé - Indicateurs biologiques - Partie 4: Indicateurs biologiques pour la stérilisation à la chaleur sèche (ISO 11138-4:2017)

Sterilizacija izdelkov za zdravstveno nego - Biološki indikatorji - 4. del: Biološki indikatorji za sterilizacijske postopke s suho toploto (ISO 11138-4:2017)

Ta dokument določa zahteve za preskusne organizme, suspenzije, vcepljene prenašalce in biološke indikatorje ter preskusne metode za uporabo pri vrednotenju učinkovitosti sterilizacijskih postopkov, ki kot sterilizacijsko sredstvo uporabljajo suho toploto pri temperaturah za sterilizacijo v razponu od 120 °C do 180 °C.
OPOMBA 1: zahteve za potrjevanje in nadzor sterilizacijskih postopkov s suho toploto zagotavlja standard ISO 20857.
OPOMBA 2: zahteve za varnost na delovnem mestu lahko zagotavljajo nacionalni ali regionalni predpisi.

General Information

• Status: Published
• Publication Date: 28-Mar-2017
• Withdrawal Date: 29-Sep-2017
• ICS: 11.080.01 - Sterilization and disinfection in general
• ICS: 11.080.20 - Disinfectants and antiseptics
• Technical Committee: CEN/TC 102 - Sterilizers for medical purposes
• Drafting Committee: CEN/TC 102 - Sterilizers for medical purposes
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 29-Mar-2017
• Completion Date: 29-Mar-2017
• 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 11138-4:2017 - Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2017)

Relations

• Replaces: EN ISO 11138-4:2006 - Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2006)
• Effective Date: 04-Apr-2017

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11138-4:2017
01-junij-2017
1DGRPHãþD
SIST EN ISO 11138-4:2006
Sterilizacija izdelkov za zdravstveno nego - Biološki indikatorji - 4. del: Biološki
indikatorji za sterilizacijske postopke s suho toploto (ISO 11138-4:2017)
Sterilization of health care products - Biological indicators - Part 4: Biological indicators
for dry heat sterilization processes (ISO 11138-4:2017)
Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren - Teil 4:
Biologische Indikatoren für Sterilisationsverfahren mit Heißluft (ISO 11138-4:2017)
Stérilisation des produits de santé - Indicateurs biologiques - Partie 4: Indicateurs
biologiques pour la stérilisation à la chaleur sèche (ISO 11138-4:2017)
Ta slovenski standard je istoveten z: EN ISO 11138-4:2017
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 11138-4:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11138-4:2017

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SIST EN ISO 11138-4:2017


EN ISO 11138-4
EUROPEAN STANDARD

NORME EUROPÉENNE

March 2017
EUROPÄISCHE NORM
ICS 11.080.20 Supersedes EN ISO 11138-4:2006
English Version

Sterilization of health care products - Biological indicators
- Part 4: Biological indicators for dry heat sterilization
processes (ISO 11138-4:2017)
Stérilisation des produits de santé - Indicateurs Sterilisation von Produkten für die
biologiques - Partie 4: Indicateurs biologiques pour la Gesundheitsfürsorge - Biologische Indikatoren - Teil 4:
stérilisation à la chaleur sèche (ISO 11138-4:2017) Biologische Indikatoren für Sterilisationsverfahren mit
Heißluft (ISO 11138-4:2017)
This European Standard was approved by CEN on 19 January 2017.

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 CEN-CENELEC Management Centre 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 CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11138-4:2017 E
worldwide for CEN national Members.

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SIST EN ISO 11138-4:2017
EN ISO 11138-4:2017 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 11138-4:2017
EN ISO 11138-4:2017 (E)
European foreword
This document (EN ISO 11138-4:2017) has been prepared by Technical Committee ISO/TC 198
“Sterilization of health care products in collaboration with Technical Committee CEN/TC 102
“Sterilizers and associated equipment for processing of medical devices”, 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 September 2017 and conflicting national standards
shall be withdrawn at the latest by September 2017.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
This document supersedes EN ISO 11138-4:2006.
The standard is a full technical revision of the previous version. The following amendments have been
made in comparison with EN ISO 11138-4:2006:
— requirements on determination of resistance characteristics (9.6) revised.
EN ISO 11138 consists of the following parts, under the general title Sterilization of health care
products — Biological indicators:
— Part 1: General requirements
— Part 2: Bi
...