SIST EN ISO 11139:2018/A1:2024
(Amendment)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)
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)
Sterilisation von Produkten für die Gesundheitsfürsorge - Vokabular, das bei der Sterilisation und zugehöriger Ausrüstung sowie in Prozessnormen verwendet wird - Änderung 1 (ISO 11139:2018/Amd 1:2024)
Stérilisation des produits de santé - Vocabulaire des termes utilisés dans les normes de procédés de stérilisation et les équipements connexes - Amendement 1: Termes et définitions modifiés et supplémentaires (ISO 11139:2018/Amd 1:2024)
Sterilizacija izdelkov za zdravstveno nego - Slovar izrazov, ki se uporabljajo pri sterilizaciji in ustrezni opremi ter pri procesnih standardih - Dopolnilo A1: Spremenjeni in dodatni izrazi in definicije (ISO 11139:2018/Amd 1:2024)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-april-2024
Sterilizacija izdelkov za zdravstveno nego - Slovar izrazov, ki se uporabljajo pri
sterilizaciji in ustrezni opremi ter pri procesnih standardih - Dopolnilo A1:
Spremenjeni in dodatni izrazi in definicije (ISO 11139:2018/Amd 1:2024)
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)
Sterilisation von Produkten für die Gesundheitsfürsorge - Vokabular, das bei der
Sterilisation und zugehöriger Ausrüstung sowie in Prozessnormen verwendet wird -
Änderung 1 (ISO 11139:2018/Amd 1:2024)
Stérilisation des produits de santé - Vocabulaire des termes utilisés dans les normes de
procédés de stérilisation et les équipements connexes - Amendement 1: Termes et
définitions modifiés et supplémentaires (ISO 11139:2018/Amd 1:2024)
Ta slovenski standard je istoveten z: EN ISO 11139:2018/A1:2024
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 11139:2018/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
January 2024
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 - Amendment 1: Amended and additional terms
and definitions (ISO 11139:2018/Amd 1:2024)
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 - Sterilisation und zugehöriger Ausrüstung sowie in
Amendement 1: Termes et définitions modifiés et Prozessnormen verwendet wird - Änderung 1 (ISO
supplémentaires (ISO 11139:2018/Amd 1:2024) 11139:2018/Amd 1:2024)
This amendment A1 modifies the European Standard EN ISO 11139:2018; it was approved by CEN on 1 July 2023.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant 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 amendment 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye 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
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11139:2018/A1:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 11139:2018/A1:2024) 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 Amendment to the European Standard EN ISO 11139:2018 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by July 2024, and
conflicting national standards shall be withdrawn at the latest by July 2024.
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.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 11139:2018/Amd 1:2024 has been approved by CEN as EN ISO 11139:2018/A1:2024
without any modification.
International
Standard
ISO 11139
First edition
Sterilization of health care
2018-08
products — Vocabulary of terms
used in sterilization and related
AMENDMENT 1
equipment and process standards
2024-01
AMENDMENT 1: Amended and
additional terms and definitions
Stérilisation des produits de santé — Vocabulaire des termes
utilisés dans les normes de procédés de stérilisation et les
équipements connexes
AMENDEMENT 1: Termes et définitions modifiés et
supplémentaires
Reference number
ISO 11139:2018/Amd.1:2024(en) © ISO 2024
ISO 11139:2018/Amd.1:2024(en)
© ISO 2024
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.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 11139:2018/Amd.1:2024(en)
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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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 www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products, in
collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/TC 102,
Sterilizers and associated equipment for processing of medical devices, in accordance with the Agreement on
technical cooperation between ISO and CEN (Vienna Agreement).
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.
iii
ISO 11139:2018/Amd.1:2024(en)
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
3.111 exposure phase
Replace the term and the text of the definition with the following:
3.111
exposure stage
cycle stage between the introduction of the sterilizing agent or disinfecting agent into the chamber and
when its microbicidal effect has become negligible
Note 1 to entry: The exposure stage comprises that part of the process for which microbial lethality is claimed.
3.113.2 F value
BIO
Replace the text of the definition with the following:
3.113.2
F value
BIO
expression of the resistance of a biological indicator calculated as the product of the logarithm to base 10 of
the initial population of microorganisms and the D value
Add the following new entry 3.113.4 F value:
BIOLOGICAL
3.113.4
F value
BIOLOGICAL
expression of the delivered lethality of a process, measured in terms of actual kill of microorganisms on or
in a biological indicator (BI) challenge system
Note 1 to entry: F can be calculated by multiplying the D value by the difference between the log to the
BIOLOGICAL 121
base ten of the starting population and the log to the base ten of the enumerated population after processing.
3.133 holding time
Replace the text of the definition with the following:
3.133
holding time
period during which process or cycle parameters are maintained within their specified tolerances for
defined cycle stages
Add the following new entry 3.133.1 holding time:
ISO 11139:2018/Amd.1:2024(en)
3.133.1
holding time
period for which the temperatures at the reference measurement point, and at all
points within the load, are continuously within the sterilization temperature band
3.151 labelling
Replace the text of the definition with the following:
3.151
labelling
label, instructions for use and any other information related to identification, technical description, intended
purpose and proper use of the medical device, but excluding shipping documents
[SOURCE: ISO 13485:2016, 3.8]
3.166 medical device
Added "in or on the human body" in the paragraph after the list, as follows:
3.166
medical device
instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, or software material,
or other similar or related article, intended by the manufacturer to be used, alone or in combination, for
human beings, for one or more of the specific medical purpose(s) of:
— diagnosis, prevention, monitoring, treatment, or alleviation of disease;
— diagnosis, monitoring, treatment, alleviation of, or compensation for an injury;
— investigation, replacement, modification, or support of the anatomy, or of a physiological process;
— supporting or sustaining life;
— control of conception;
— disinfection of medical devices;
— providing information by means of in vitro examination of specimens derived from the human body;
and which does not achieve its primary intended action by pharmacological, immunological, or metabolic
means, in or on the human body, but which may be assisted in its intended function by such means
Note 1 to entry: Products which may be considered to be medical devices in some jurisdictions, but not in others
include:
— items specifically intended for cleaning or sterilization of medical devices;
— pouches, reel goods, sterilization wrap, and reusable containers for packaging of medical devices for sterilization;
— disinfection substances;
— aids for persons with disabilities;
— devices incorporating animal and/or human tissues;
— devices for in vitro fertilization or assisted reproduction technologies.
3.214 processing
ISO 11139:2018/Amd.1:2024(en)
Add new entry number and definition as follows:
3.214.1
processing
activity performed in the preparation, manipulation, preservation for
storage and packaging of a biological or tissue-based product
Renumber 3.214 processing as:
3.214.2
processing
3.254 simulated product
Replace the text of the definition with the following:
3.254
simulated product
item intended to represent specified c
...
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