EN ISO 11139:2018

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

Contents Page
European foreword . 3

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 11139.
ISO 11139 mentions a „White Paper“ in the ISO Foreword. CEN does not endorse this „White Paper“ for
the following reasons:
 there was no official standardisation request for the preparation of such a document,
 the document has not been developed according to CEN Internal Regulations and
 the document is outside the scope of EN ISO 11139.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: 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 the United Kingdom.
Endorsement notice
The text of ISO 11139:2018 has been approved by CEN as EN ISO 11139:2018 without any modification.
INTERNATIONAL ISO
STANDARD 11139
First edition
2018-08
Sterilization of health care products —
Vocabulary of terms used in
sterilization and related equipment
and process standards
Stérilisation des produits de santé — Vocabulaire des termes utilisés
dans les normes de procédés de stérilisation et les équipements
connexes
Reference number
ISO 11139:2018(E)
©
ISO 2018
ISO 11139:2018(E)
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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.
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Published in Switzerland
ii © ISO 2018 – All rights reserved

ISO 11139:2018(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
Annex A (informative) Summary of standards in which each term is included in their
respective Clause 3 .33
Bibliography .45
ISO 11139:2018(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 to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www .iso .org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
This first edition of ISO 11139 cancels and replaces ISO/TS 11139:2006, which has been technically
revised.
The main changes compared with the previous edition are as follows:
— all the terms and definitions have been reviewed based on existing documents in the field and future
needs, and have been revised accordingly for consistency of use;
NOTE This vocabulary is now the source document for these terms.
— additional terms and definitions have been added.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/members .html.
iv © ISO 2018 – All rights reserved

ISO 11139:2018(E)
Introduction
This document provides the fundamental vocabulary for sterilization of health care products and
associated equipment. It provides the foundation for other standards on cleaning, disinfecting,
sterilizing, and aseptic processing of health care products together with associated equipment and
ancillary products used in ensuring effective application of these processes. This document is intended
to help the user to understand the vocabulary of cleaning, disinfecting, sterilizing, and aseptically
processing health care products, in order to be able to implement the related standards effectively.
This document contains the terms and definitions that apply to all standards on cleaning, disinfecting,
sterilizing, and aseptic processing of health care products together with associated equipment
and ancillary products developed by ISO/TC 198 and other European standards in the same field of
application.
The terms and definitions are arranged in alphabetical order in English.
ISO/TC 198 has produced a white paper describing the principles used to develop this compilation
of terms and definitions and proposals on its use in the development of new and revised standards
for disinfecting, sterilizing, and aseptic processing of health care products together with associated
equipment and ancillary products. This white paper is available through the International Organization
for Standardization.
The Bibliography includes the standards referenced in Annex A. If a term has been dropped in a current
revision, reference has not been made.
INTERNATIONAL STANDARD ISO 11139:2018(E)
Sterilization of health care products — Vocabulary of terms
used in sterilization and related equipment and process
standards
1 Scope
This document defines terms in the field of the sterilization of health care products including related
equipment and processes.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/
3.1
A
measure of microbiological lethality delivered by a moist heat disinfection process expressed in terms
of the equivalent time in seconds at 80 °C with reference to a microorganism with a z value of 10 K
3.2
absolute pressure
pressure for which the zero value is associated with absolute vacuum
3.3
absorbed dose
quantity of ionizing radiation energy imparted per unit mass of a specified material
3.4
access device
means by which entry to restricted parts of equipment is achieved
Note 1 to ent
...