prEN ISO 18562-1
(Main)Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process (ISO/DIS 18562-1:2022)
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process (ISO/DIS 18562-1:2022)
ISO 18562-1:2017 specifies:
- the general principles governing the biological evaluation within a risk management process of the gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments;
- the general categorization of gas pathways based on the nature and duration of their contact with the gas stream;
- the evaluation of existing relevant data from all sources;
- the identification of gaps in the available data set on the basis of a risk analysis;
- the identification of additional data sets necessary to analyse the biological safety of the gas pathway;
- the assessment of the biological safety of the gas pathway.
ISO 18562-1:2017 covers general principles regarding biocompatibility assessment of medical device materials, which make up the gas pathway, but does not cover biological hazards arising from any mechanical failure, unless the failure introduces a toxicity risk (e.g. by generating particulates). The other parts of ISO 18562 cover specific tests that address potentially hazardous substances that are added to the respirable gas stream and establish acceptance criteria for these substances.
ISO 18562-1:2017 addresses potential contamination of the gas stream arising from the gas pathways within the medical device, which might then be conducted to the patient.
ISO 18562-1:2017 applies over the expected service life of the medical device in normal use and takes into account the effects of any intended processing or reprocessing.
ISO 18562-1:2017 does not address biological evaluation of the surfaces of medical devices that are in direct contact with the patient. The requirements for direct contact surfaces are found in the ISO 10993 series.
Medical devices, parts or accessories containing gas pathways that are addressed by this document include, but are not limited to, ventilators, anaesthesia workstations (including gas mixers), breathing systems, oxygen conserving equipment, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, mouth pieces, resuscitators, breathing tubes, breathing system filters and Y-pieces as well as any breathing accessories intended to be used with such medical devices. The enclosed chamber of an incubator, including the mattress, and the inner surface of an oxygen hood are considered to be gas pathways and are also addressed by this document.
ISO 18562-1:2017 does not address contamination already present in the gas supplied from the gas sources while medical devices are in normal use.
EXAMPLE Contamination arriving at the medical device from gas sources such as medical gas pipeline systems (including the non-return valves in the pipeline outlets), outlets of pressure regulators connected or integral to a medical gas cylinder, or room air taken into the medical device is not addressed by ISO 18562 (all parts).
Future parts might be added to address other relevant aspects of biological testing including additional contamination that might arise from the gas pathway because of the presence of drugs and anaesthetic agents added to the gas stream.
NOTE 1 Some authorities having jurisdiction require evaluation of these risks as part of a biological evaluation.
NOTE 2 This document has been prepared to address the relevant essential principles of safety and performance as indica
Beurteilung der Biokompatibilität der Atemgaswege bei medizinischen Anwendungen - Teil 1: Beurteilung und Prüfung innerhalb eines Risikomanagement-Prozesses (ISO/DIS 18562-1:2022)
Évaluation de la biocompatibilité des chemins de gaz respiratoires dans les applications de soins de santé - Partie 1: Évaluation et essais au sein d'un processus de gestion du risque (ISO/DIS 18562-1:2022)
ISO 18562-1:2017 spécifie:
- les principes généraux gouvernant l'évaluation biologique au sein d'un processus de gestion du risque des chemins de gaz utilisés dans un dispositif médical, ses parties ou ses accessoires, qui sont destinés à dispenser des soins respiratoires ou à fournir des substances par les voies respiratoires à un patient dans tous les types d'environnements;
- la classification générale des chemins de gaz, fondée sur la nature et la durée de leur contact avec le flux gazeux;
- l'évaluation de toutes les données existantes;
- l'identification de manques dans les ensembles de données disponibles sur la base d'une analyse de risque;
- l'identification d'ensembles de données supplémentaires nécessaires à l'analyse de la sécurité biologique du chemin de gaz;
- l'évaluation de la sécurité biologique du chemin de gaz.
ISO 18562-1:2017 couvre les principes généraux relatifs à l'évaluation de la biocompatibilité des matériaux constituant un dispositif médical, qui composent le chemin de gaz, mais ne couvre pas les phénomènes dangereux biologiques causés par une défaillance mécanique, à moins que celle-ci n'introduise un risque de toxicité (par exemple en générant des particules). Les autres parties de l'ISO 18562 couvrent des essais spécifiques traitant des substances potentiellement dangereuses qui sont ajoutées au flux de gaz respirable et établissant les critères d'acceptation de ces substances.
ISO 18562-1:2017 traite de la contamination potentielle du flux gazeux provenant des chemins de gaz utilisés dans un dispositif médical, qui pourrait ensuite être acheminé jusqu'au patient.
ISO 18562-1:2017 s'applique pour la durée de vie prévue du dispositif médical en utilisation normale et prend en compte les effets associés à tout traitement ou retraitement prévu.
ISO 18562-1:2017 ne traite pas de l'évaluation biologique des surfaces des dispositifs médicaux qui sont en contact direct avec le patient. Les exigences relatives aux surfaces en contact direct sont indiquées dans la série de normes ISO 10993.
Les dispositifs médicaux, leurs parties ou accessoires, contenant des chemins de gaz et faisant l'objet du présent document, comprennent, mais sans s'y limiter, les ventilateurs, les systèmes d'anesthésie (y compris les mélangeurs de gaz), les systèmes respiratoires, les économiseurs d'oxygène, les concentrateurs d'oxygène, les nébuliseurs, les flexibles de raccordement à basse pression, les humidificateurs, les échangeurs de chaleur et d'humidité, les moniteurs de gaz respiratoires, les moniteurs de respiration, les masques, les embouts buccaux, les appareils de réanimation, les tubes respiratoires, les filtres de système respiratoire, les raccords en Y ainsi que tous les accessoires respiratoires destinés à être utilisés avec ces dispositifs médicaux. La chambre fermée d'un incubateur, y compris le matelas et la surface intérieure d'une cloche de Hood, sont considérés comme des chemins de gaz et sont également couverts par le présent document.
ISO 18562-1:2017 ne traite pas de la contamination déjà présente dans le gaz provenant des sources de gaz lors d'une utilisation normale des dispositifs médicaux.
EXEMPLE La contamination arrivant dans le dispositif médical et provenant de sources de gaz telles que des systèmes de distribution de gaz médicaux (notamment les clapets anti-retour situés sur les prises murales), les sorties des détendeurs raccordés ou intégrés à une bouteille de gaz médical, ou l'air ambiant envoyé dans le d
Ovrednotenje biokompatibilnosti vdihanega plina za uporabo v zdravstvu - 1. del: Ovrednotenje in preskušanje znotraj procesa obvladovanja tveganja (ISO/DIS 18562-1:2022)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 18562-1:2023
01-januar-2023
Ovrednotenje biokompatibilnosti vdihanega plina za uporabo v zdravstvu - 1. del:
Ovrednotenje in preskušanje znotraj procesa obvladovanja tveganja (ISO/DIS
18562-1:2022)
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1:
Evaluation and testing within a risk management process (ISO/DIS 18562-1:2022)
Beurteilung der Biokompatibilität der Atemgaswege bei medizinischen Anwendungen -
Teil 1: Beurteilung und Prüfung innerhalb eines Risikomanagement-Prozesses (ISO/DIS
18562-1:2022)
Évaluation de la biocompatibilité des chemins de gaz respiratoires dans les applications
de soins de santé - Partie 1: Évaluation et essais au sein d'un processus de gestion du
risque (ISO/DIS 18562-1:2022)
Ta slovenski standard je istoveten z: prEN ISO 18562-1
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 18562-1:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 18562-1:2023
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oSIST prEN ISO 18562-1:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 18562-1
ISO/TC 121/SC 3 Secretariat: ANSI
Voting begins on: Voting terminates on:
2022-11-04 2023-01-27
Biocompatibility evaluation of breathing gas pathways in
healthcare applications —
Part 1:
Evaluation and testing within a risk management process
Évaluation de la biocompatibilité des chemins de gaz respiratoires dans les applications de soins de
santé —
Partie 1: Évaluation et essais au sein d'un processus de gestion du risque
ICS: 11.040.10
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
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oSIST prEN ISO 18562-1:2023
ISO/DIS 18562-1:2022(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 18562-1
ISO/TC 121/SC 3 Secretariat: ANSI
Voting begins on: Voting terminates on:
Biocompatibility evaluation of breathing gas pathways in
healthcare applications —
Part 1:
Evaluation and testing within a risk management process
Évaluation de la biocompatibilité des chemins de gaz respiratoires dans les applications de soins de
santé —
Partie 1: Évaluation et essais au sein d'un processus de gestion du risque
ICS: 11.040.10
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 2022
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NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 18562-1:2022(E)
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ii
© ISO 2022 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022
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oSIST prEN ISO 18562-1:2023
ISO/DIS 18562-1:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 General principles applying to biocompatibility evaluation of medical devices .11
4.1 General . 11
4.2 Type tests . 13
4.3 Biocompatibility hazard identification . 13
4.4 Extent of risk assessment . . 14
4.5 Biocompatibility evaluation plan . 14
4.6 Selection of tests . 16
4.7 Subsequent evaluation . 17
5 Contamination of breathing gas from gas pathways .17
5.1 Duration of contact . 17
5.2 Particulate matter (PM) emissions . 18
5.3 Volatile organic substance emissions . 18
5.4 Leachables in condensate . 18
6 Adjustment for different patient groups .18
6.1 General considerations. 18
6.2 Adjustment for body weight . 19
7 Deriving allowable limits .20
7.1 General process . 20
7.2 For medical devices intended for limited exposure use (≤24 h) . 21
7.3 For medical devices intended for prolonged exposure use (>24 h but <30 d) . 21
7.4 For medical devices intended for long-term exposure (≥30 d) .22
8 Risk control .22
9 Benefit-risk analysis .23
10 Biocompatibility evaluation report .23
Annex A (informative) Rationale and guidance .24
Annex B (informative) Reference to the IMDRF essential principles and labelling guidances .27
Annex C (informative) Reference to the essential principles .29
Annex ZA (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered .30
Bibliography .33
Terminology — Alphabetized index of defined terms .35
iii
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oSIST prEN ISO 18562-1:2023
ISO/DIS 18562-1:2022(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 on the voluntary nature of ISO 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 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 of ISO 18562-1 cancels and replaces the first edition of ISO 18562-1.
The main changes compared to the previous edition are as follows:
— reformatted according to most recent Central Secretariat editing rules;
— added informative mapping annexes to relevant regulatory requirements;
— clarified terms and definitions used in the document;
— clarified the appropriate breathing gas volumes to used in the analysis.
A list of all parts in the ISO 18562 series can be found on the ISO website.
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
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oSIST prEN ISO 18562-1:2023
ISO/DIS 18562-1:2022(E)
Introduction
This document represents the application of the best-known science, in order to improve patient safety,
by addressing the risk of potentially hazardous substances being conveyed to the patient by the gas
stream.
This document is intended to cover the biological evaluation of gas pathways of medical devices within
a risk management process, as part of the overall medical device evaluation and development. This
approach combines the review and evaluation of existing data from all sources with, where necessary,
the selection and application of additional tests.
In general, the ISO 10993 series is intended to cover the biological evaluation of medical devices.
However, the ISO 10993 series does not sufficiently address the biological evaluation of the gas pathways
of medical devices.
Before this document was developed, some authorities having jurisdiction interpreted the
ISO 10993-1:2009, Table A.1 to mean that materials in the gas pathway form “indirect contact” with the
patient, and should be subjected to tests equivalent to those required for tissue contact parts of medical
devices. This interpretation can lead to tests with questionable utility and also to possible hazards not
being detected.
ISO 10993-1:2018 states that it is not intended to provide a rigid set of test methods as this might result
in an unnecessary constraint on the development and use of novel medical devices. ISO 10993-1:2018
also states where a particular application warrants it, experts in the product or in the area of application
concerned can choose to establish specific tests and criteria, described in a product-specific vertical
standard. This new series of standards is intended to address the specific needs for the evaluation of
gas pathways that are not adequately covered by ISO 10993-1:2018.
This document provides a guide to the development of a biological evaluation plan that minimizes the
number and exposure of test animals by giving preference to chemical constituent testing and in vitro
models.
The initial version of this series of standards was intended to cover only the most commonly found
potentially harmful substances. It was felt that it was best to get a functioning document published that
would test for the bulk of the currently known substances of interest. With the use of the TTC (threshold
of toxicological concern) approach, this document has the potential to be used to assess the safety of
essentially any compound released from the gas pathways of respiratory medical devices, with very few
exceptions (e.g. PCBs, dioxins), and not just the most commonly found potentially harmful substances.
In this document, the following print types are used:
— requirements and definitions: roman type;
— terms defined in Clause 3 of this document or as noted and test specifications: italic type;
— informative material appearing outside of tables, such as notes, examples and references: in smaller
type. Normative text of tables is also in a smaller type;
This document has been prepared in consideration of:
— the Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices, IMDRF/
[15]
GRRP WG/N47:2018 as indicated in Annex B;
[16]
— the Labelling Principles for Medical Devices and IVD Medical Devices, IMDRF/GRRP WG/N52:2019
as indicated in Annex B;
[8]
— the essential principles of safety and performance of a medical device according to ISO 16142-1:2016
as indicated in Annex C; and
— the general safety and performance requirements of a medical device according to regulation
[17]
(EU) 2017/745 .
v
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oSIST prEN ISO 18562-1:2023
ISO/DIS 18562-1:2022(E)
In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
For the purposes of this document, the auxiliary verb:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— "can" is used to describe a possibility or capability;
— "must" is used express an external constraint.
Requirements in this document have been decomposed so that each requirement is uniquely delineated.
This is done to support automated requirements tracking.
vi
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oSIST prEN ISO 18562-1:2023
DRAFT INTERNATIONAL STANDARD ISO/DIS 18562-1:2022(E)
Biocompatibility evaluation of breathing gas pathways in
healthcare applications —
Part 1:
Evaluation and testing within a risk management process
1 Scope
This document specifies:
— the general principles governing the biological evaluation within a risk management process of the
gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory
care or supply substances via the respiratory tract to a patient in all environments;
— the general categorization of gas pathways based on the nature and duration of their contact with
the gas stream;
— the evaluation of existing relevant data from all sources;
— the identification of gaps in the available data set on the basis of a risk analysis;
— the identification of additional data sets necessary to analyse the biological safety of the gas pathway;
— the assessment of the biological safety of the gas pathway.
This document covers general principles regarding biocompatibility assessment of medical device
materials, which make up the gas pathway, in normal use and normal condition. This document does not
cover biological hazards arising from mechanical damage.
The other parts of ISO 18562 cover specific tests that address potentially hazardous substances that
are added to the respirable gas stream and establish acceptance criteria for these substances.
This document addresses potential contamination of the gas stream arising from the gas pathways
within the medical device, which might then be conducted to the patient.
This document applies over the expected lifetime of the medical device when operated according to the
instructions for use. This includes degradation arising from exposure to environmental conditions as
well as cleaning, disinfection and sterilisation (i.e. processing). It also includes user action or inaction
(omission) that leads to an unintended or unexpected outcome (result) (i.e. use error). It does not include
conscious/intentional action or inaction that violates the instructions for use and is beyond reasonable
risk control by the manufacturer (i.e. abnormal use).
This document does not address biological evaluation of the surfaces of medical devices that have direct
contact with the patient or user. The requirements for direct contact surfaces are found in the ISO 10993
series.
Medical devices, parts or accessories containing gas pathways that are addressed by this document
include, but are not limited to, ventilators, anaesthesia workstations (including gas mixers), breathing
systems, oxygen conserving equipment, oxygen concentrators, nebulizers, low-pressure hose
assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors,
masks, mouth pieces, resuscitators, breathing tubes, breathing system filters and Y-pieces as well as
any breathing accessories intended to be used with such medical devices. The enclosed chamber of an
incubator, including the mattress, and the inner surface of an oxygen hood are considered to be gas
pathways and are also addressed by this document.
1
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oSIST prEN ISO 18562-1:2023
ISO/DIS 18562-1:2022(E)
This document does not address contamination already present in the gas supplied from the gas sources
while medical devices are in normal use.
EXAMPLE Contamination arriving at the medical device from gas sources such as medical gas pipeline systems
(including the non-return valves in the pipeline outlets), outlets of pressure regulators connected or integral to a
medical gas cylinder, or room air taken into the medical device is not addressed by ISO 18562 (all parts).
Future parts might be added to address other relevant aspects of biological testing including additional
contamination that might arise from the gas pathway because of the presence of drugs and anaesthetic
agents added to the gas stream, and potential contamination by emission of inorganic gases such as
ozone, CO, CO , and NO .
2 x
NOTE Some authorities having jurisdiction require evaluation of these risks as part of a biological evaluation.
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
1)
ISO 10993-17:— , Biological evaluation of medical devices — Part 17: Establishment of allowable limits for
leachable substances
2)
ISO 18562-2:— , Biocompatibility evaluation of breathing gas pathways in healthcare applications —
Part 2: Tests for emissions of particulate matter
3)
ISO 18562-3:— , Biocompatibility evaluation of breathing gas pathways in healthcare applications —
Part 3: Tests for emissions of volatile organic substances
4)
ISO 18562-4:— , Biocompatibility evaluation of breathing gas pathways in healthcare applications —
Part 4: Tests for leachables in condensate
ISO/TS 21726, Biological evaluation of medical devices — Application of the threshold of toxicological
concern (TTC) for assessing biocompatibility of medical device constituents
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at https:// www .electropedia .org/
— ISO Online browsing platform: available at https:// www .iso .org/ obp
NOTE For convenience, an alphabetized index of terms and their sources used in this document is found at
the end of this document.
1) Under preparation. Stage at the time of publication: ISO/FDIS 10993 17:2022.
2) Under preparation. Stage at the time of publication: ISO/DIS 18562-2:2022.
3) Under preparation. Stage at the time of publication: ISO/DIS 18562-3:2022.
4) Under preparation. Stage at the time of publication: ISO/DIS 18562-4:2022.
2
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oSIST prEN ISO 18562-1:2023
ISO/DIS 18562-1:2022(E)
3.1
abnormal use
conscious, deliberate act or deliberate omission of an act that is counter to or violates normal use and
is also beyond any further reasonable means of user interface-related risk control by the manufacturer
EXAMPLE Reckless use or sabotage or intentional deliberate disregard of information for SAFETY are such
acts.
Note 1 to entry: An intended but erroneous action that is not abnormal use is considered a type of use error.
Note 2 to entry: Abnormal use does not relieve the manufacturer from considering non-user interface-related
means of risk control.
Note 3 to entry: Figure 1 shows the relationships of the types of use.
Figure 1 — Relationship of the types of use
[SOURCE: IEC 62366-1+AMD1: 2020, 3.1, modified — deleted note 1.]
3.2
accessory
item, intended specifically by its manufacturer, to be used together with one or more medical devices to
specifically enable or assist those medical devices to be used in accordance with their intended use
Note 1 to entry: An accessory is typically a consumable or separate item for use with one or more medical devices.
Note 2 to entry: Some authorities having jurisdiction consider an accessory to be a medical device.
Note 3 to entry: Some authorities having jurisdiction have a different definition of accessory.
[SOURCE: ISO 20417:2021, 3.1]
3.3
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
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oSIST prEN ISO 18562-1:2023
ISO/DIS 18562-1:2022(E)
3.4
authority having jurisdiction
regulatory authority
governmental agency or office assigned to oversee the regulation of a regulated product within a
country, jurisdiction, or assigned territory
[SOURCE: ISO 16142-1:2016, 3.1]
3.5
benefit
positive impact or desirable outcome of the use of a medical device on the health of an individual, or a
positive impact on patient management or public health
Note 1 to entry: Benefits can include positive impact on clinical outcome, the patient’s quality of life, outcomes
related to diagnosis, positive impact from diagnostic devices on clinical outcomes, or positive impact on public
health.
[SOURCE: ISO 14971:2019, 3.2]
3.6
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.
3.7
essential principles
essential principles of safety and performance
fundamental high-level requirements that when complied with ensure a medical device is safe and
performs as intended
[SOURCE: ISO 16142-1:2016, 3.3]
3.8
expected lifetime
expected service life
time period specified by the manufacturer during which the medical device or accessory is expected to
remain safe and effective for use
Note 1 to entry: The expected lifetime can be affected by the stability of the medical device or accessory or by the
materials in the medical device or accessory.
Note 2 to entry: Maintenance, repairs or upgrades (e.g., safety or cybersecurity modifications) can be necessary
during the expected lifetime.
Note 3 to entry: Some medical devices have an absolute lifetime (e.g., 5 y), whereas other medical devices (e.g.,
software) have a relative lifetime (e.g., the time between two major releases).
[SOURCE: ISO 20417:2021, 3.7, modified — added to note 1 “of the medical device or accessory or by the
materials in the medical device or accessory” deleted note 4.]
3.9
exposure dose
quantity of a chemical constituent that does, or
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