EN ISO 18778:2022
(Main)Respiratory equipment - Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors (ISO 18778:2022)
Respiratory equipment - Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors (ISO 18778:2022)
This document applies to the basic safety and essential performance of an infant cardiorespiratory monitor, as defined in 3.10, hereafter also referred to as ME equipment, in combination with its accessories:
— intended for use in the home healthcare environment;
— intended for use by a lay operator;
— intended to monitor cardiorespiratory parameters in sleeping or resting children under three years of age; and
— intended for transit-operable use.
NOTE An infant cardiorespiratory monitor can also be used in professional health care facilities.
This document is also applicable to those accessories intended by their manufacturer to be connected to the infant cardiorespiratory monitor, where the characteristics of those accessories can affect the basic safety or essential performance of the infant cardiorespiratory monitor.
EXAMPLE probes, cables distributed alarm system
Medizinische elektrische Geräte - Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von kardiorespiratorischen Überwachungsgeräten für Kleinkinder (ISO 18778:2022)
Dieses Dokument ist anzuwenden für die Basissicherheit und die wesentlichen Leistungsmerkmale von kardiorespiratorischen Überwachungsgeräten für Kleinkinder, wie in 3.10 definiert, im Folgenden auch als ME-Geräte bezeichnet, in Kombination mit ihrem Zubehör:
— für die medizinische Versorgung in häuslicher Umgebung vorgesehen;
— zur Benutzung durch einen nicht fachkundigen Bediener bestimmt;
— zur Überwachung kardiorespiratorischer Parameter bei schlafenden oder ruhenden Kindern unter drei Jahren vorgesehen;
— für den bei Bewegung betriebsfähigen Gebrauch vorgesehen.
ANMERKUNG Kardiorespiratorische Überwachungsgeräte für Kleinkinder können auch in gewerblichen Gesundheitseinrichtungen verwendet werden.
Dieses Dokument gilt auch für Zubehör, für das der Hersteller den Anschluss an ein kardiorespiratorisches Überwachungsgerät für Kleinkinder vorsieht, bei dem die Merkmale dieses Zubehörs die Basissicherheit oder die wesentlichen Leistungsmerkmale des kardiorespiratorischen Überwachungsgeräts für Kleinkinder beein¬flussen können.
BEISPIEL Sonden, Kabel verteiltes Alarmsystem
Matériel respiratoire - Exigences particulières relatives à la sécurité de base et aux performances essentielles des moniteurs cardiorespiratoires pour nourrissons (ISO 18778:2022)
Le présent document s’applique à la sécurité de base et aux performances essentielles des moniteurs cardiorespiratoires pour nourrissons, tels que définis en 3.10, ci-après également désignés appareils EM, lorsqu’ils sont associés à leurs accessoires:
— destinés à être utilisés dans l’environnement des soins à domicile;
— destinés à être utilisés par un opérateur non spécialiste;
— destinés à la surveillance des paramètres cardiorespiratoires chez les enfants de moins de trois ans endormis ou au repos; et
— destinés à être opérationnels en déplacement.
NOTE Un moniteur cardiorespiratoire pour nourrissons peut également être utilisé dans les établissements de soins professionnels.
Le présent document s’applique également aux accessoires conçus par leur fabricant pour être raccordés à un moniteur cardiorespiratoire pour nourrissons, lorsque les caractéristiques de ces accessoires peuvent affecter la sécurité de base ou les performances essentielles du moniteur cardiorespiratoire pour nourrissons.
EXEMPLE sondes, câbles système d’alarme réparti.
Respiratorna oprema - Posebne zahteve za osnovno varnost in bistveno učinkovitost opreme za kardiorespiratorne monitorje za otroke (ISO 18778:2022)
Ta dokument se uporablja za osnovno varnost in bistveno učinkovitost opreme za kardiorespiratorne monitorje za otroke,
kot je opredeljeno v točki 3.10, v nadaljevanju poimenovane tudi elektromedicinska oprema, in sicer skupaj z dodatno opremo, ki je namenjena:
– za uporabo v okolju domače zdravstvene oskrbe;
– nestrokovnjakom;
– za spremljanje kardiorespiratornih parametrov pri otrocih, ki spijo ali počivajo in so mlajši
od treh let; ter
– za delovanje med nošenjem.
OPOMBA: Oprema za kardiorespiratorne monitorje za otroke se lahko uporablja tudi v zdravstvenih ustanovah.
Ta dokument se uporablja tudi za dodatno opremo, ki jo je proizvajalec predvidel za priklop na
opremo za kardiorespiratorne monitorje za otroke, pri čemer lahko lastnosti te dodatne opreme vplivajo na osnovno
varnost ali bistvene lastnosti opreme za kardiorespiratorne monitorje za otroke.
PRIMER: Sonde, kabli, distribuiran alarmni sistem.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2023
Nadomešča:
SIST EN ISO 18778:2009
Respiratorna oprema - Posebne zahteve za osnovno varnost in bistveno
učinkovitost opreme za kardiorespiratorne monitorje za otroke (ISO 18778:2022)
Respiratory equipment - Particular requirements for basic safety and essential
performance of infant cardiorespiratory monitors (ISO 18778:2022)
Medizinische elektrische Geräte - Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von kardiorespiratorischen
Überwachungsgeräten für Kleinkinder (ISO 18778:2022)
Matériel respiratoire - Exigences particulières relatives à la sécurité de base et aux
performances essentielles des moniteurs cardiorespiratoires pour nourrissons (ISO
18778:2022)
Ta slovenski standard je istoveten z: EN ISO 18778:2022
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 18778
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2022
EUROPÄISCHE NORM
ICS 11.040.10; 11.040.55 Supersedes EN ISO 18778:2009
English Version
Respiratory equipment - Particular requirements for basic
safety and essential performance of infant
cardiorespiratory monitors (ISO 18778:2022)
Matériel respiratoire - Exigences particulières relatives Medizinische elektrische Geräte - Besondere
à la sécurité de base et aux performances essentielles Festlegungen für die Sicherheit einschließlich der
des moniteurs cardiorespiratoires pour nourrissons wesentlichen Leistungsmerkmale von
(ISO 18778:2022) kardiorespiratorischen Überwachungsgeräten für
Kleinkinder (ISO 18778:2022)
This European Standard was approved by CEN on 17 June 2022.
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, 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
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 18778:2022 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 18778:2022) has been prepared by Technical Committee ISO/TC 121
"Anaesthetic and respiratory equipment" in collaboration with Technical Committee CEN/TC 215
“Respiratory and anaesthetic equipment” the secretariat of which is held by BSI.
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 April 2023, and conflicting national standards shall be
withdrawn at the latest by April 2023.
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.
This document supersedes EN ISO 18778:2009.
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 18778:2022 has been approved by CEN as EN ISO 18778:2022 without any modification.
INTERNATIONAL ISO
STANDARD 18778
Second edition
2022-06
Respiratory equipment — Particular
requirements for basic safety and
essential performance of infant
cardiorespiratory monitors
Matériel respiratoire — Exigences particulières relatives à la
sécurité de base et aux performances essentielles des moniteurs
cardiorespiratoires pour nourrissons
Reference number
ISO 18778:2022(E)
ISO 18778:2022(E)
© ISO 2022
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 18778:2022(E)
Contents Page
Foreword . vi
Introduction .viii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements . 6
4.1 General . 6
4.2 Essential performance . 6
4.3 ME equipment or ME system parts that contact the patient . 6
4.4 Single fault condition for ME equipment . 6
5 General requirements for testing of ME equipment . 6
5.1 General . 6
5.2 Infant cardiorespiratory monitor testing errors . 6
6 Classification of ME equipment and ME systems. 7
6.1 General . 7
6.2 Additional requirements for classification of ME equipment and ME systems . 7
7 ME equipment identification, marking and documents. 7
7.1 General . 7
7.2 Information to be supplied by the manufacturer . 7
7.3 Additional requirements for accessories . 7
7.4 Additional requirements for marking on the outside of ME equipment or
ME equipment parts . 8
7.5 General instructions for use . 8
7.6 Additional requirements for warnings and safety notices . 8
7.7 Additional requirements for start-up procedure . 9
7.8 Additional requirements for operating instructions . 9
7.8.1 General . 9
7.8.2 Lay operator operating instructions . 9
7.8.3 Healthcare professional operator operating instructions . 10
7.9 Cleaning, disinfection, and sterilization . 10
7.10 Additional requirements for maintenance . 10
7.11 Additional requirements for accessories, supplementary equipment, used material . 10
7.12 Additional requirements for the technical description . 10
8 Protection against electrical hazards from ME equipment .11
9 Protection against mechanical hazards of ME equipment and ME systems.11
9.1 General . 11
9.2 Additional requirements for instability from unwanted lateral movement . 11
9.3 Grips and other handling devices . 11
10 Protection against unwanted and excessive radiation hazards .11
11 Protection against excessive temperatures and other hazards .11
11.1 General . 11
11.2 Cleaning and disinfection of ME equipment or ME system .12
11.3 Sterilization of ME equipment or ME system .12
11.4 Biocompatibility of ME equipment and ME systems .12
11.5 Interruption of the power supply / supply mains to ME equipment .13
11.5.1 General .13
11.5.2 Power sources . 13
11.5.3 Alternative power supply/supply mains . 14
12 Accuracy of controls and instruments and protection against hazardous outputs .14
iii
ISO 18778:2022(E)
12.1 General . 14
12.2 Accuracy of controls and instruments . 14
12.3 Accuracy of controls and instruments . 15
12.3.1 General .15
12.3.2 Cardiorespiratory monitoring . 15
12.3.3 Direct monitoring - respiration. 15
12.3.4 Indirect monitoring – heart rate . 15
12.3.5 Indirect monitoring from pulse oximetry . 15
12.3.6 Apnoeic patient alarm condition. 16
12.3.7 Sensor fault . 17
12.3.8 Clinical performance evaluation . 17
12.4 Usability of ME equipment . 17
13 Hazardous situations and fault conditions for ME equipment .18
14 Programmable electrical medical systems (PEMS) .18
15 Construction of ME equipment .18
15.1 General . 18
15.2 Mode of operation . 18
15.3 Pre-use check . 18
16 ME systems .19
17 Electromagnetic compatibility of ME equipment and ME systems .19
18 Requirements for the accessories .19
18.1 General . 19
18.2 Labelling . 19
19 Training .19
20 Functional connection . .19
20.1 General . 19
20.2 Connection to an electronic health record . 19
20.3 Connection to a distributed alarm system . 19
21 Electromagnetic disturbances – Requirements and tests.20
21.1 General . 20
21.2 Compliance criteria . 20
21.3 Requirements applicable to all ME equipment and ME systems . 20
21.4 Additional general requirements . 20
22 Usability .20
22.1 General . 20
22.2 Primary operating functions . 21
23 General requirements, tests and guidance for alarm systems in medical electrical
equipment and medical electrical systems .21
23.1 General . 21
23.2 Volume and characteristics of auditory alarm signals and information signals . 21
23.3 Additional requirements for termination of alarm signal inactivation . 21
23.4 Additional requirements for alarm system logging . 22
24 Requirements for medical electrical equipment and medical electrical systems used
in the home healthcare environment .22
Annex A (informative) General guidance and rationale .23
Annex B (informative) Sequence of testing .28
Annex C (informative) Guide to marking and labelling requirements for ME equipment and
ME systems .29
Annex D (informative) Symbols on marking .32
iv
ISO 18778:2022(E)
Annex E (informative) Examples of the connection of the measuring device (MD) for
measurement of the patient leakage current and patient auxiliary current .33
Annex F (informative) Suitable measuring supply circuits .34
Annex G (informative) Protection against hazards of ignition of flammable anaesthetic
mixtures .35
Annex H (informative) PEMS structure, PEMS development life-cycle and documentation .36
Annex I (informative) ME systems aspects .37
Annex J (informative) Survey of insulation paths .38
Annex K (informative) Simplified patient leakage current diagrams .39
Annex L (informative) Insulated winding wires for use without interleaved insulation .40
Annex M (informative) Reduction of pollution degrees .41
Annex N (informative) Data interface requirements .42
Annex O (informative) Considerations for a clinical performance study .45
Annex P (informative) Reference to the IMDRF essential principles and labelling guidances .47
Annex Q (informative) Reference to the essential principles .49
Annex R (informative) Reference to the general safety and performance requirements .51
Bibliography .54
Terminology — Alphabetized index of defined terms .55
v
ISO 18778:2022(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 121, Anaesthetic and respiratory
equipment, Subcommittee SC 3, Lung ventilators and related equipment, in collaboration with the
European Committee for Standardization (CEN) Technical Committee CEN/TC 215, Respiratory and
anaesthetic equipment, in accordance with the Agreement on technical cooperation between ISO and
CEN (Vienna Agreement).
This second edition cancels and replaces the first (ISO 18778:2005), which has been technically revised.
The main changes are as follows:
— extending the scope to include the infant cardiorespiratory monitor and its accessories, where the
characteristics of those accessories can affect the basic safety or essential performance of the infant
cardiorespiratory monitor, and thus not only the infant cardiorespiratory monitor itself;
— identification of essential performance of an infant cardiorespiratory monitor and its accessories;
— harmonization with the third edition of IEC 60601-1;
and the following additions:
— tests for infant cardiorespiratory monitor performance;
— tests for mechanical strength (via IEC 60601-1-11);
— requirements for transit-operable use;
— new symbols;
— requirements for an infant cardiorespiratory monitor as a component of an ME system;
— requirement for both a direct measurement of respiration, and an indirect measurement of apnoeic
activity;
— tests for enclosure integrity (water ingress via IEC 60601-1-11);
vi
ISO 18778:2022(E)
— tests for cleaning and disinfection procedures (via IEC 60601-1-11); and
— harmonization with ISO 20417.
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.
vii
ISO 18778:2022(E)
Introduction
This document specifies requirements for infant cardiorespiratory monitors called in previous
working documents “infant apnoea monitors or infant monitors”. Infant cardiorespiratory monitors are
intended to be used primarily to monitor cardiorespiratory parameters for patients less than 3 years
of age. Infant cardiorespiratory monitors are required to include at least one direct measurement of
respiration and one indirect measurement of apnoeic activity such as heart rate or oxygen saturation.
Infant cardiorespiratory monitors are intended for use in the home healthcare environment. Infant
cardiorespiratory monitors are frequently used in locations where supply mains is not reliable. Infant
cardiorespiratory monitors are often supervised by non-healthcare personnel (lay operators) with
varying levels of training. An infant cardiorespiratory monitor conforming with this document can be
used elsewhere (i.e., in healthcare facilities).
Annex A contains guidance or rationale to indicated clauses and subclauses.
Annex C contains a guide to the marking and labelling requirements in this document.
Annex D contains a summary of the symbols referenced in this document.
If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems
only, the title and content of that clause or subclause will say so. If that is not the case, the clause or
subclause applies both to ME equipment and to ME systems, as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME systems within
the scope of this document are not covered by specific requirements in this document except in
IEC 60601-1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.
NOTE 1 Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.
The object of this document is to establish particular basic safety and essential performance requirements
for an infant cardiorespiratory monitor, as defined in 3.10, and its accessories.
Accessories are included because the combination of the infant cardiorespiratory monitor and the
accessories needs to be adequately safe. Accessories can have a significant impact on the basic safety or
essential performance of the infant cardiorespiratory monitor.
[6] [7]
NOTE 2 This document has been prepared to address the relevant essential principles and labelling
guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex P.
NOTE 3 This document has been prepared to address the relevant essential principles of safety and performance
of ISO 16142-1:2016 as indicated in Annex Q.
NOTE 4 This document has been prepared to address the relevant general safety and performance
[8]
requirements of European regulation (EU) 2017/745 as indicated in Annex R.
viii
INTERNATIONAL STANDARD ISO 18778:2022(E)
Respiratory equipment — Particular requirements
for basic safety and essential performance of infant
cardiorespiratory monitors
1 Scope
This document applies to the basic safety and essential performance of an infant cardiorespiratory monitor,
as defined in 3.10, hereafter also referred to as ME equipment, in combination with its accessories:
— intended for use in the home healthcare environment;
— intended for use by a lay operator;
— intended to monitor cardiorespiratory parameters in sleeping or resting children under three years
of age; and
— intended for transit-operable use.
NOTE An infant cardiorespiratory monitor can also be used in professional health care facilities.
This document is also applicable to those accessories intended by their manufacturer to be connected to
the infant cardiorespiratory monitor, where the characteristics of those accessories can affect the basic
safety or essential performance of the infant cardiorespiratory monitor.
EXAMPLE probes, cables distributed alarm system
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 10993-1:2018, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 14155:2020, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 16142-1:2016, Medical devices — Recognized essential principles of safety and performance of medical
devices — Part 1: General essential principles and additional specific essential principles for all non-IVD
medical devices and guidance on the selection of standards
ISO 17664-2:2021, Processing of health care products — Information to be provided by the medical device
manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
ISO 18562-1:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications —
Part 1: Evaluation and testing within a risk management process
ISO 20417:2021, Medical devices — Information to be supplied by the manufacturer
ISO 80601-2-61:2017, Medical electrical equipment — Part 2-61: Particular requirements for basic safety
and essential performance of pulse oximeter equipment
IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, Medical electrical equipment — Part 1: General requirements
for basic safety and essential performance
ISO 18778:2022(E)
IEC 60601-1-2:2014+AMD1: 2020, Medical electrical equipment — Part 1-2: General requirements for basic
safety and essential performance — Collateral Standard: Electromagnetic disturbances - Requirements and
tests
IEC 60601-1-6:2010+AMD1: 2013+ AMD2: 2020, Medical electrical equipment — Part 1-6: General
requirements for basic safety and essential performance — Collateral standard: Usability
IEC 60601-1-8:2006+AMD1: 2012+ AMD2: 2020, Medical electrical equipment — Part 1-8: General
requirements for basic safety and essential performance — Collateral Standard: General requirements,
tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
IEC 60601-1-11:2015+AMD1: 2020, Medical electrical equipment — Part 1-11: General requirements
for basic safety and essential performance — Collateral Standard: Requirements for medical electrical
equipment and medical electrical systems used in the home healthcare environment
IEC 60601-2-27:2011, Medical electrical equipment – Part 2-27: Particular requirements for the basic safety
and essential performance of electrocardiographic monitoring equipment
IEC 62366-1:2015+AMD1: 2020, Medical devices — Application of usability engineering to medical devices
IEC 62570:2014, Standard practice for marking medical devices and other items for safety in the magnetic
resonance environment
IEC Guide 115:2021, Application of uncertainty of measurement to conformity assessment activities in the
electrotechnical sector
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 16142-1, ISO 17664-2,
ISO 18562-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-1-11, IEC 62366-1,
and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
accompanying information
information accompanying or marked on a medical device or accessory for the user or those accountable
for the installation, use, processing, maintenance, decommissioning and disposal of the medical device
or accessory, particularly regarding safe use
Note 1 to entry: The accompanying information shall be regarded as part of the medical device or accessory.
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).
[SOURCE: ISO 20417:2021, 3.2, modified — deleted note 4.]
3.2
apnoea
cessation of breathing lasting 10 s or more
ISO 18778:2022(E)
3.3
biocompatibility
ability to be in contact with a living system without producing an unacceptable adverse effect
Note 1 to entry: Medical devices may produce some level of adverse effect, but that level may be determined to be
acceptable when considering the benefits provided by the medical device.
[SOURCE: ISO 18562-1:2017, 3.2]
3.4
central apnoea
apnoea where there is a cessation of output from the central respiratory centres, and no respiratory
effort
3.5
cleaning
removal of contaminants to the extent necessary for further processing or for intended use
Note 1 to entry: Cleaning consists of the removal, usually with detergent and water, of adherent soil (e.g. blood,
protein substances, and other debris) from the surfaces, crevices, serrations, joints, and lumens of a medical
device by a manual or automated process that prepares the items for safe handling or further processing.
[SOURCE: ISO 17664-2:2017, 3.1, modified — replaced "and/or" with "or" in note 1.]
3.6
clinical investigation
systematic investigation in one or more human subjects, undertaken to assess the clinical performance,
effectiveness or safety of a medical device
Note 1 to entry: For the purpose of this document, “clinical trial” or “clinical study” are synonymous with “clinical
investigation”.
[SOURCE: ISO 14155:2020, 3.8]
3.7
clinical investigation plan
CIP
document that states the rationale, objectives, design and pre-specified analysis, methodology,
organization, monitoring, conduct and record-keeping of the clinical investigation (3.6)
Note 1 to entry: For the purpose of this document “protocol” is synonymous with “CIP”. However, protocol has
many different meanings, some not related to clinical investigation, and these can differ from country to country.
Therefore, the term CIP is used in this document.
[SOURCE: ISO 14155:2020, 3.9]
3.8
disinfection
process to reduce the number of viable microorganisms to a level previously specified as being
appropriate for a defined purpose
[SOURCE: ISO 17664-2:2021, 3.3]
3.9
healthcare professional
individual with appropriate training, knowledge and skills who provides preventive, curative,
promotional or rehabilitative healthcare services in a systematic way to people, families or communities
[SOURCE: ISO 4135:2022, 3.1.6.2]
3.10
infant cardiorespiratory monitor
ME equipment intended to monitor cardiorespiratory parameters for patients less than 3 years of age
ISO 18778:2022(E)
3.11
information supplied by the manufacturer
information related to the identification and use of a medical device or accessory, in whatever form
provided, intended to ensure the safe and effective use of the medical device or accessory
Note 1 to entry: For the purposes of this document, e-documentation is included in information supplied by the
manufacturer.
Note 2 to entry: For the purposes of this document, shipping documents and promotional material are excluded
from information supplied by the manufacturer. However, some authorities having jurisdiction can consider such
supplemental information as information supplied by the manufacturer.
Note 3 to entry: The primary purpose of information supplied by the manufacturer is to identify the medical device
and its manufacturer, and provide essential information about its safety, performance, and appropriate use to the
user or other relevant persons.
[SOURCE: ISO 20417:2021, 3.10, modified — deleted note 4.]
3.12
instructions for use
IFU
portion of the accompanying information that is essential for the safe and effective use of a medical
device or accessory directed to the user of the medical device
Note 1 to entry: For the purposes of this document, a user can be either a lay user or professional user with
relevant specialized training.
Note 2 to entry: For the purposes of this document, instructions for the professional processing between uses of a
medical device or accessory can be included in the instructions for use.
Note 3 to entry: The instructions for use, or portions thereof, can be located on the display of a medical device or
accessory.
Note 4 to entry: Medical devices or accessories that can be used safely and effectively without instructions for use
are exempted from having instructions for use by some authorities having jurisdiction.
[SOURCE: ISO 20417:2021, 3.11, modified — deleted note 5.]
3.13
marking
information, in text or graphical format, durably affixed, printed, etched (or equivalent) to a medical
device or accessory
Note 1 to entry: For the purposes of this document, the term marked is used to designate the corresponding act.
Note 2 to entry: For the purposes of this document, marking is different from ‘direct marking’ as commonly
described in unique device identification (UDI) standards and regulations. A UDI ‘direct marking’ is a type of
marking.
[SOURCE: ISO 20417:2021, 3.16, modified — deleted note 3.]
3.14
obstructive apnoea
apnoea due to airway obstruction
3.15
processing
activity to prepare a new or used medical device or accessory
for its intended use
[SOURCE: ISO 20417:2021, 3.20]
ISO 18778:2022(E)
3.16
single use
intended by the manufacturer to be used on an individual patient or
specimen during a single procedur
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