SIST EN ISO 11139:2018

Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards (ISO 11139:2018)

This International Standard defines terms in the field of sterilization of healthcare products used in the standards developed by ISO/TC 198 "Sterilization of healthcare products", CEN/TC 204 "Sterilization of medical devices", and CEN/TC 102 "Sterilizers and associated equipment for processing of medical devices".

Sterilisation von Produkten für die Gesundheitsfürsorge - Vokabular, das bei der Sterilisation und zugehöriger Ausrüstung sowie in Prozessnormen verwendet wird (ISO 11139:2018)

Dieses Dokument definiert Begriffe aus dem Bereich der Sterilisation von Produkten für die Gesundheitsfürsorge einschließlich der zugehörigen Ausrüstung und Verfahren.

Stérilisation des produits de santé - Vocabulaire des termes utilisés dans les normes de procédés de stérilisation et les équipements connexes (ISO 11139:2018)

Le présent document définit les termes employés dans le domaine de la stérilisation des produits de santé, y compris les équipements et processus connexes.

Sterilizacija izdelkov za zdravstveno nego - Slovar izrazov, ki se uporabljajo pri sterilizaciji in ustrezni opremi ter pri procesnih standardih (ISO 11139:2018)

Ta mednarodni standard določa pogoje na področju sterilizacije izdelkov za zdravstveno nego, ki se uporabljajo v standardih ISO/TC 198 Sterilizacija izdelkov za zdravstveno nego, CEN/TC 204 Sterilizacija medicinskih pripomočkov ter CEN/TC 102 Sterilizatorji in povezana oprema za obdelavo medicinskih pripomočkov.

General Information

• Status: Published
• Public Enquiry End Date: 19-Oct-2017
• Publication Date: 13-Nov-2018
• Withdrawal Date: 01-Feb-2024
• ICS: 01.040.11 - Health care technology (Vocabularies)
• ICS: 11.080.01 - Sterilization and disinfection in general
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 19-Oct-2018
• Due Date: 24-Dec-2018
• Completion Date: 14-Nov-2018
• Ref Project: EN ISO 11139:2018 - Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards (ISO 11139:2018)

Relations

• Amended By: SIST EN ISO 11139:2018/A1:2024 - Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards - Amendment 1: Amended and additional terms and definitions (ISO 11139:2018/Amd 1:2024)
• Effective Date: 01-Apr-2024

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11139:2018
01-december-2018
Sterilizacija izdelkov za zdravstveno nego - Slovar izrazov, ki se uporabljajo pri
sterilizaciji in ustrezni opremi ter pri procesnih standardih (ISO 11139:2018)
Sterilization of health care products - Vocabulary of terms used in sterilization and
related equipment and process standards (ISO 11139:2018)
Sterilisation von Produkten für die Gesundheitsfürsorge - Vokabular, das bei der
Sterilisation und zugehöriger Ausrüstung sowie in Prozessnormen verwendet wird (ISO
11139:2018)
Stérilisation des produits de santé - Vocabulaire des termes utilisés dans les normes de
procédés de stérilisation et les équipements connexes (ISO 11139:2018)
Ta slovenski standard je istoveten z: EN ISO 11139:2018
ICS:
01.040.11 Zdravstveno varstvo Health care technology
(Slovarji) (Vocabularies)
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 11139:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11139:2018

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SIST EN ISO 11139:2018


EN ISO 11139
EUROPEAN STANDARD

NORME EUROPÉENNE

September 2018
EUROPÄISCHE NORM
ICS 01.040.11; 11.080.01
English Version

Sterilization of health care products - Vocabulary of terms
used in sterilization and related equipment and process
standards (ISO 11139:2018)
Stérilisation des produits de santé - Vocabulaire des Sterilisation von Produkten für die
termes utilisés dans les normes de procédés de Gesundheitsfürsorge - Vokabular, das bei der
stérilisation et les équipements connexes (ISO Sterilisation und zugehöriger Ausrüstung sowie in
11139:2018) Prozessnormen verwendet wird (ISO 11139:2018)
This European Standard was approved by CEN on 1 September 2018.

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: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11139:2018 E
worldwide for CEN national Members.

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SIST EN ISO 11139:2018
EN ISO 11139:2018 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 11139:2018
EN ISO 11139:2018 (E)
European foreword
This document (EN ISO 11139:2018) 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 March 2019, and conflicting national standards shall
be withdrawn at the latest by March 2019.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
According to CEN Internal Regulations, terms and definition are always developed for a specific subject
of the relevant standard/specification of the relevant working group. The working group uses the
advice of the terminology working group to ensure that new terms and definitions are in line with the
regulations and not in conflict with existing terms and definitions. Whenever possible, terms and
definitions can be taken form the terminology standard EN ISO 11
...