ISO 11139:2018/Amd 1:2024
(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
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
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
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INTERNATIONAL ISO
STANDARD 11139
First edition
2018-08
AMENDMENT 1
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
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
PROOF/ÉPREUVE
Reference number
ISO 11139:2018/Amd.1:2023(E)
© ISO 2023
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ISO 11139:2018/Amd.1:2023(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
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
PROOF/ÉPREUVE © ISO 2023 – All rights reserved
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ISO 11139:2018/Amd.1:2023(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 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 for medical purposes, 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 2023 – All rights reserved PROOF/ÉPREUVE
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ISO 11139:2018/Amd.1:2023(E)
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 microorganis
...
ISO 11139:2018/PRF Amd .1:2023(E)
ISO/TC 198/WG5
Secretariat: ANSI
Date: 2023-09-1811-03
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
Stérilisation des produits de santé — Vocabulaire des termes utilisés dans les normes de procédés de
stérilisation et les équipements connexes
AMENDMENT 1 : Amended and additional terms and definitions
---------------------- Page: 1 ----------------------
AMENDEMENT 1: Termes et définitions modifiés et supplémentaires
FDIS stage
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ISO 11139:2018/Amd.1:2023(E)
© ISO 20232018
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
EmailE-mail: copyright@iso.org
Website: www.iso.orgwww.iso.org
Published in Switzerland
© ISO 2023 – All rights reserved 3
---------------------- Page: 3 ----------------------
ISO 11139:2018/PRF Amd .1:2023(E)
Contents
Foreword iv
4 © ISO 2023 – All rights reserved
iv © ISO 2023 – All rights reserved
---------------------- Page: 4 ----------------------
ISO 11139:2018/PRF Amd .1:2023(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 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.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.htmlwww.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 for medical purposes, 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.
Field Code Changed
© ISO 2023 – All rights reserved 5
© ISO 2023 – All rights reserved v
---------------------- Page: 5 ----------------------
ISO 11139:2018/PRF Amd 1(E)
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 ne
...
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