SIST EN ISO 11139:2018/oprA1:2023
(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 definition (ISO 11139:2018/DAM 1:2023)
Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards - Amendment 1: Amended and additional terms and definition (ISO 11139:2018/DAM 1:2023)
Sterilisation von Produkten für die Gesundheitsfürsorge - Vokabular, das bei der Sterilisation und zugehöriger Ausrüstung sowie in Prozessnormen verwendet wird - Änderung 1 (ISO 11139:2018/DAM 1:2023)
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 supplémentaire (ISO 11139:2018/DAM 1:2023)
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/DAM 1:2023)
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11139:2018/oprA1:2023
01-maj-2023
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/DAM 1:2023)
Sterilization of health care products - Vocabulary of terms used in sterilization and
related equipment and process standards - Amendment 1: Amended and additional
terms and definition (ISO 11139:2018/DAM 1:2023)
Sterilisation von Produkten für die Gesundheitsfürsorge - Vokabular, das bei der
Sterilisation und zugehöriger Ausrüstung sowie in Prozessnormen verwendet wird -
Änderung 1 (ISO 11139:2018/DAM 1:2023)
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 supplémentaire (ISO 11139:2018/DAM 1:2023)
Ta slovenski standard je istoveten z: EN ISO 11139:2018/prA1
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/oprA1:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11139:2018/oprA1:2023
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SIST EN ISO 11139:2018/oprA1:2023
DRAFT AMENDMENT
ISO 11139:2018/DAM 1
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
2023-03-07 2023-05-30
Sterilization of health care products — Vocabulary of terms
used in sterilization and related equipment and process
standards
AMENDMENT 1: Amended and additional terms and definition
ICS: 11.080.01; 01.040.11
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO 11139:2018/DAM 1:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023
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SIST EN ISO 11139:2018/oprA1:2023
ISO 11139:2018/DAM 1:2023(E)
DRAFT AMENDMENT
ISO 11139:2018/DAM 1
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
Sterilization of health care products — Vocabulary of terms
used in sterilization and related equipment and process
standards
AMENDMENT 1: Amended and additional terms and definition
ICS: 11.080.01; 01.040.11
This document is circulated as received from the committee secretariat.
COPYRIGHT PROTECTED DOCUMENT
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
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or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
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ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: +41 22 749 01 11
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: copyright@iso.org
NATIONAL REGULATIONS.
Website: www.iso.org ISO 11139:2018/DAM 1:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
© ISO 2023 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023
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SIST EN ISO 11139:2018/oprA1:2023
ISO 11139:2018/DAM 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 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
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
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
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SIST EN ISO 11139:2018/oprA1:2023
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SIST EN ISO 11139:2018/oprA1:2023
ISO 11139:2018/DAM 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 definition
3.111
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 the agent is removed or neutralised
3.113.2
Delete 3.113.2 and renumber 3.113.3 to 3.113.2.
3.133
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
3.151
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
Replace the text of the definition with the following:
1
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SIST EN ISO 11139:2018/oprA1:2023
ISO 11139:2018/DAM 1:2023(E)
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 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.
[SOURCE: ISO 13485:2016, 3.11, modified — “In or on the human body” has been added to the definition
and the first two list items in Note 1 to entry have been added]
3.214
Renumber as follows:
3.214.2
processing
activity to prepare a new or used health care product for its intended
use
3.230
Delete.
3.231
Delete.
2
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SIST EN ISO 11139:2018/oprA1:2023
ISO 11139:2018/DAM 1:2023(E)
3.254
Replace the text of the definition with the following:
3.254
simulated product
item intended to represent specified characteristics of a product or product family used to demonstrate
a defined performance of a process related to these characteristics
3.293.1
Replace the text of the definition with the following:
3.293.1
temperature band
range of temperatures expressed as the minimum and maximum temperatures in the
usable chamber space during a holding time
Note 1 to entry: An operating cycle can comprise more than one holding time
3.296
Replace the text of the definition with the following:
3.296
terminally sterilized
exposed to a successful sterilization process in its sterile barrier system
Clause 3
Add the following:
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
3.214.1
processing
activity performed in the preparation, manipulation, preservation
for storage and packaging of a biological or tissue-based product
3.328
acceptance range
range within which the statistic under consideration lies with a specified probability
when the process is in a state of control
3.329
accompanying information
information accompanying or marked on a medical device or accessory and containing information for
the user or those accountable for the installation, use, maintenance, decommissioning and disposal of
the medical device or accessory, particularly regarding safe use
Note 1 to entry: The accompanying information can be regarded as part of the medical device or accessory.
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SIST EN ISO 11139:2018/oprA1:2023
ISO 11139:2018/DAM 1:2023(E)
Note 2 to entry: The accompanying information can consist of the label, marking, instructions for use, technical
description, installation manual, quick reference guide, etc.
Note 3 to entry: Accompanying information is not necessarily a written or printed document but could involve
auditory, visual, or tactile materials and multiple media types (e.g. CD/DVD-ROM, USB stick, website).
Note 4 to entry: The label can include the information on the packaging of the medical device.
Note 5 to entry: E-documentation can include any or all types of information supplied by the manufacturer
partially or entirely.
Note 6 to entry: Marketing information is also known as promotional material.
[SOURCE: ISO 20417:2021, 3.2, modified — the term “processing” has been removed, Note 1 to entry
has been modified to exclude a requirement, Note 4 to entry has been deleted, and Notes 5 to 7 have
been renumbered 4 to 6]
3.330
biologic
product that is synthesized from living organisms, or their products, and used as a diagnostic,
preventive or therapeutic agent
3.331
companion tissue
tissue from the same donor(s) that is not intended to be used for transplantation
3.332
contained product sterilization
validated process where indirect contact of a heating medium on the external surfaces of contained
product to create moist heat internally to achieve the specified requirements for sterility within the
contained product
3.333
critical medical device
item, processed in a washer-disinfector, intended to be introduced directly into,
or have contact with, the vascular system or normally sterile areas of the body
EXAMPLE Surgical instruments.
Note 1 to entry: Critical medical devices will usually require sterilization before use
Note 2 to entry: There can be national regulations with alternative wording for this term
3.334
donor identification
unique identifier assigned to all transplantable tissue and companion tissue that orig
...
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