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

This document defines terms in the field of the sterilization of health care products including related equipment and processes.

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
Publication Date
11-Sep-2018
Withdrawal Date
30-Mar-2019
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
12-Sep-2018
Completion Date
12-Sep-2018

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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

---------------------- Page: 2 ----------------------

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
...

SLOVENSKI STANDARD
oSIST prEN ISO 11139:2017
01-oktober-2017
Sterilizacija izdelkov za zdravstveno nego - Slovar - Izrazi, ki se uporabljajo pri
sterilizaciji in ustrezni opremi ter pri procesnih standardih (ISO/DIS 11139:2017)
Sterilization of health care products - Vocabulary - Terms used in sterilization and related
equipment and process standards (ISO/DIS 11139:2017)
Sterilisation von Produkten für die Gesundheitsfürsorge - Vokabular -Begriffe, die bei der
Sterilisation und zugehörigen Geräten sowie in Prozessnormen verwendet werden
(ISO/DIS 11139:2017)
Stérilisation des produits de santé - Vocabulaire (ISO/DIS 11139:2017)
Ta slovenski standard je istoveten z: prEN ISO 11139
ICS:
01.040.11 Zdravstveno varstvo Health care technology
(Slovarji) (Vocabularies)
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
oSIST prEN ISO 11139:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 11139:2017

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oSIST prEN ISO 11139:2017
© ISO 2017 – All rights reserved
ISO /TC 198

Date:  2017-06-05
ISO/DIS 11139:2017(E)
ISO/TC 198/WG 5
Secretariat:  AAMI (for ANSI)
Sterilization of health care products — Vocabulary - terms used in
sterilization and related equipment and process standards

Stérilisation des produits de santé — Vocabulaire

DIS stage

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oSIST prEN ISO 11139:2017
ISO/DIS 11139:2017(E)
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized
otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the
internet or an intranet, without prior written permission. Permission can be requested from either ISO at the
address below or ISO’s member body in the country of the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved

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oSIST prEN ISO 11139:2017
ISO/DIS 11139:2017(E)
Contents Page
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Bibliography . 46
Annex A (informative) . 50
Excluded terms . 50
Annex B (informative) . 56
Graphical example of the different time definitions in moist heat disinfection and sterilization
processes to illustrate the use of the terms . 56
Graphical representation of examples of the different period definitions used in a resistometer test . 57

© ISO 2017 – All rights reserved iii

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oSIST prEN ISO 11139:2017
ISO/DIS 11139:2017(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national
standards bodies (ISO member bodies). The work of preparing International Standards is normally
carried out through ISO technical committees. Each member body interested in a subject for which a
technical committee has been established has the right to be represented on that committee.
International organizations, governmental and non-governmental, in liaison with ISO, also take part in
the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all
matters of electrotechnical standardization.
The procedures used
...

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