SIST EN ISO 18113-1:2024
(Main)In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements (ISO 18113-1:2022)
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements (ISO 18113-1:2022)
This document defines concepts, establishes general principles, and specifies essential requirements for information supplied by the manufacturer of IVD medical devices.
This document does not address language requirements since that is the domain of national laws and regulations.
This document does not apply to:
a) IVD medical devices for performance evaluation (e.g. for investigational use only);
b) shipping documents;
c) material safety data sheets / Safety Data Sheets;
d) marketing information (consistent with applicable legal requirements).
.
In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 1: Begriffe und allgemeine Anforderungen (ISO 18113-1:2022)
In diesem Dokument werden Konzepte definiert, allgemeine Prinzipien aufgestellt und wesentliche Anforderungen an die durch den Hersteller von In vitro-Diagnostika bereitgestellten Informationen festgelegt.
Dieses Dokument enthält keine Festlegungen zu sprachlichen Anforderungen, da diese in den Bereich nationaler Gesetze und Vorschriften fallen.
Dieses Dokument ist nicht anwendbar für
a) In vitro-Diagnostika zur Leistungsbewertung (z. B. nur für Forschungszwecke),
b) Versanddokumente,
c) Datenblätter zur Materialsicherheit,
d) Marketing-Informationen (in Übereinstimmung mit den geltenden rechtlichen Anforderungen).
Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 1: Termes, définitions et exigences générales (ISO 18113-1:2022)
Le présent document définit les concepts, établit les principes généraux et spécifie les exigences essentielles relatives aux informations fournies par le fabricant de dispositifs médicaux de DIV.
Le présent document ne traite pas des exigences relatives à la langue, car ces dernières relèvent du domaine des législations et réglementations nationales.
Le présent document ne s’applique pas à ce qui suit :
a) dispositifs médicaux de DIV utilisés pour l’évaluation des performances (par exemple pour un usage expérimental uniquement) ;
b) documents d’expédition ;
c) fiches de données de sécurité / fiches signalétiques des matériaux ;
d) informations marketing (conformément aux exigences légales applicables).
In vitro diagnostični preskusni sistemi - Informacije proizvajalca (označevanje) - 1. del: Izrazi, definicije in splošne zahteve (ISO 18113-1:2022)
Ta dokument opredeljuje koncepte ter določa splošna načela in bistvene zahteve za informacije, ki jih mora zagotoviti proizvajalec in vitro diagnostičnih (IVD) preskusnih sistemov.
Ne obravnava zahtev glede jezika, ki so določene v nacionalnih zakonih in predpisih.
Ta dokument se ne uporablja za:
a) in vitro diagnostične preskusne sisteme za vrednotenje delovanja (npr. samo za uporabo v raziskavah);
b) odpremno dokumentacijo;
c) varnostne liste (za materiale);
d) tržne informacije (v skladu z veljavnimi zakonskimi zahtevami).
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2024
In vitro diagnostični preskusni sistemi - Informacije proizvajalca (označevanje) - 1.
del: Izrazi, definicije in splošne zahteve (ISO 18113-1:2022)
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling)
- Part 1: Terms, definitions, and general requirements (ISO 18113-1:2022)
In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 1:
Begriffe und allgemeine Anforderungen (ISO 18113-1:2022)
Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant
(étiquetage) - Partie 1: Termes, définitions et exigences générales (ISO 18113-1:2022)
Ta slovenski standard je istoveten z: EN ISO 18113-1:2024
ICS:
01.040.11 Zdravstveno varstvo Health care technology
(Slovarji) (Vocabularies)
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 18113-1
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2024
EUROPÄISCHE NORM
ICS 11.100.10 Supersedes EN ISO 18113-1:2011
English Version
In vitro diagnostic medical devices - Information supplied
by the manufacturer (labelling) - Part 1: Terms,
definitions, and general requirements (ISO 18113-1:2022)
Dispositifs médicaux de diagnostic in vitro - In-vitro-Diagnostika - Bereitstellung von
Informations fournies par le fabricant (étiquetage) - Informationen durch den Hersteller - Teil 1: Begriffe
Partie 1: Termes, définitions et exigences générales und allgemeine Anforderungen (ISO 18113-1:2022)
(ISO 18113-1:2022)
This European Standard was approved by CEN on 2 October 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
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 18113-1:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard the General Safety
and Performance Requirements of Regulation (EU) 2017/746 aimed to be covered . 4
European foreword
This document (EN ISO 18113-1:2024) has been prepared by Technical Committee ISO/TC 212
"Medical laboratories and in vitro diagnostic systems" in collaboration with Technical Committee
CEN/TC 140 “In vitro diagnostic medical devices” the secretariat of which is held by DIN.
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 December 2024, and conflicting national standards
shall be withdrawn at the latest by June 2027.
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 18113-1:2011.
This document has been prepared under a standardization request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
For the relationship with EU Legislation, see informative Annex ZA, which is an integral part of this
document.
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 18113-1:2022 has been approved by CEN as EN ISO 18113-1:2024 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard the General Safety and
Performance Requirements of Regulation (EU) 2017/746 aimed to be
covered
This European standard has been prepared under M/575 to provide one voluntary means of
conforming to the General Safety and Performance Requirements of Regulation (EU) 2017/746 of 5
April 2017 concerning in vitro diagnostic medical devices [OJ L 117] and to system or process
requirements including those relating to quality management systems, risk management, post-market
surveillance systems, performance studies, clinical evidence or post-market performance follow-up.
Once this standard is cited in the Official Journal of the European Union under that Regulation,
compliance with the normative clauses of this standard given in Table ZA.1 and application of the
edition of the normatively referenced standards as given in Table ZA.2 confers, within the limits of the
scope of this standard, a presumption of conformity with the corresponding General Safety and
Performance Requirements of that Regulation, and associated EFTA Regulations.
For the purpose of using this standard in support of the requirements set out in Regulation (EU)
2017/746, the definitions set out in this Regulation prevail.
This document needs to be considered together with the other parts of EN ISO 18113-series to fully
apply the concepts of this labelling standard series. EN ISO 18113-1 provides definitions and overall
concepts which may be further applied or directed to specific device format and labelling location.
Where the European standard is an adoption of an International Standard, the scope of this standard
can differ from the scope of the European Regulation that it supports. As the scope of the applicable
regulatory requirements differ from nation to nation and region to region, the standard can only
support European regulatory requirements to the extent of the scope of the In vitro Diagnostic
Regulation (EU) 2017/746.
Where the standard includes notes that require alignment to local or regional regulations, all clauses
need to be read in the context of Regulation (EU) 2017/746.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Regulation (EU) 2017/746. This means that risks have to be
‘reduced as far as possible’, ‘reduced to a level as low as reasonably practicable’, ‘reduced to the lowest possible
level’, ‘reduced as far as possible and appropriate’, ‘removed or reduced as far as possible’, ‘eliminated or reduced
as far as possible’, ‘prevented’ or ‘minimized’, according to the wording of the corresponding General Safety and
Performance Requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety
and Performance Requirements 1, 2, 3, 4, 5, 8, 10, 11, 13, 15, 16, 17, 18 and 19 of the Regulation.
NOTE 3 When a General Safety and Performance Requirement does not appear in Table ZA.1, it means that it is
not addressed by this European Standard.
Table ZA.1 — Correspondence between this European Standard and Annex I of
Regulation (EU) 2017/746 [OJ L 117] and to system or process requirements including those relating
to quality management systems, risk management, post-market surveillance systems, clinical
investigations, clinical evaluation or post-market clinical follow-up
General Safety and
Clause(s) / sub-clause(s)
Performance Requirements of Remarks / Notes
of this EN
Regulation (EU) 2017/746
20.1. a) 4.1.1, 4.6.2 Covered
20.1. d) 4.6.1 Covered
20.1. d) 4.6.6 Covered with respect to
clarifying that IFU can supplied
either in hard copy or electronic
format
20.1 f) 4.6.6, 4.6.7, 4.6.8 Covered with respect to other
formats of IFU except for near
patient testing. Note that the
clauses cited here apply only for
professional-use devices as per
the note within section 4.6.6.
when applied to Regulation (EU)
2017/746.
20.1. g) 4.8.1, 4.8.2, 4.8.3 Covered with respect to the
intended users of the device
20.1. h) 4.3.1 – 4.3.3 Covered
20.4.1. ad) 4.10 Assistance Covered with respect to
instructions on how to obtain
assistance.
Table ZA.2 — Applicable Standards to confer presumption of conformity as described in this
Annex ZA
Column 1 Column 2 International Column 3 Column 4
Reference in Standard Edition
Title Corresponding European
Clause 2
Standard Edition
ISO 13485 ISO 13485:2016 Medical devices — EN ISO 13485:2016
Quality management
EN ISO
systems —
13485:2016/AC:2018
Requirements for
EN ISO
regulatory purposes
13485:2016/A11:2021
ISO 14971 ISO 14971:2019 Medical devices — EN ISO 14971:2019
Application of risk
EN ISO
management to medical
14971:2019/A11:2021
devices
ISO 15223-1 ISO 15223-1:2021 Medical devices — EN ISO 15223-1:2021
Symbols to be used with
information to be
supplied by the
manufacturer — Part 1:
General requirements
IEC 62366-1 IEC 62366-1:2015 Medical devices — Part EN 62366-1:2015
1: Application of
IEC 62366-1:2015/Cor 1:20 EN 62366-1:2015/AC:2015
usability engineering to
EN 62366-1:2015/A1:2020
medical devices
IEC 62366-1:2015/A1:2020
The documents listed in the Column 1 of Table ZA.2, in whole or in part, are normatively referenced in
this document and are indispensable for its application. The achievement of the presumption of
conformity is subject to the application of the edition of Standards as listed in Column 4 or, if no
European Standard Edition exists, the International Standard Edition given in Column 2 of Table ZA.2.
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the product(s) falling within the scope of
this standard.
INTERNATIONAL ISO
STANDARD 18113-1
Second edition
2022-10
In vitro diagnostic medical devices —
Information supplied by the
manufacturer (labelling) —
Part 1:
Terms, definitions, and general
requirements
Dispositifs médicaux de diagnostic in vitro — Informations fournies
par le fabricant (étiquetage) —
Partie 1: Termes, définitions et exigences générales
Reference number
ISO 18113-1:2022(E)
ISO 18113-1:2022(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 18113-1:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 General terms and definitions for use with in vitro diagnostic medical devices . 2
3.2 Performance characteristic terms and definitions . 22
4 General requirements for information supplied by the manufacturer .40
4.1 General .40
4.2 Language . 41
4.3 Symbols and identification colours . 41
4.4 Values and nomenclature . 41
4.5 Microbiological state . 42
4.6 Instructions for use . 42
4.7 Changes to the IVD medical device . 43
4.8 Disclosure of residual risks . 43
4.9 Identification of components . 43
4.10 Assistance . 43
Annex A (informative) Performance characteristics of IVD medical devices . 44
Bibliography .50
iii
ISO 18113-1:2022(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 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 212, Clinical laboratory testing and in
vitro diagnostic test systems, in collaboration with the European Committee for Standardization (CEN)
Technical Committee CEN/TC 140, In vitro diagnostic medical devices, in accordance with the Agreement
on technical cooperation between ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 18113-1:2009), which has been technically
revised.
The main changes are as follows:
— Updated terms and definitions;
— References to the UDI (Unique Device Identifier/Identification) requirement added;
— Updated Bibliography to align with updates of standards and publications;
— Updated to align with European Union and other regulations;
— Added additional detail for clarification.
A list of all parts in the ISO 18113 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
ISO 18113-1:2022(E)
Introduction
Manufacturers of in vitro diagnostic (IVD) medical devices supply users with information to enable the
safe use and expected performance of their devices. Traditionally, this information has been provided
in the form of labels, package inserts and user manuals, where the type and level of detail would depend
on the intended uses and country-specific regulations.
The International Medical Device Regulators Forum (IMDRF) encourages convergence of the evolution
of regulatory systems for medical devices at the global level. The goal is to facilitate trade while
preserving the right of participating members to address the protection of public health by regulatory
means. Consistent worldwide labelling requirements offer significant benefits to manufacturers, users,
patients and regulatory authorities. Eliminating differences among regulatory jurisdictions can allow
patients earlier access to new technologies and treatments by decreasing the time necessary to gain
regulatory compliance. This document provides a basis for harmonization of labelling requirements for
IVD medical devices. As per ISO 20417, the ISO 18113 series represents a group standard and, therefore,
has precedence with regards to the labelling requirements for IVDs.
The Global Harmonization Task Force (GHTF) now replaced by IMDRF (See Reference [52]) has
established guiding principles that apply to the labelling of medical devices and IVDs. These principles
have been incorporated into the ISO 18113 series. Of particular note, IMDRF states that country-specific
requirements for the content, wording and format of labels and instructions for use should be kept to a
minimum and eliminated over time as the opportunities arise.
This document contains a comprehensive list of terms and definitions necessary to develop the labelling
for IVD medical devices. Internationally agreed-upon definitions of important concepts promote
greater consistency in IVD medical device labelling. While the goal is to standardize the terminology
used in IVD medical device labelling to the extent possible, it is also recognized that current national
and regional usage by medical laboratories, healthcare providers, patients and regulatory authorities
should be taken into consideration
An obstacle to the timely and affordable availability of IVD medical devices in some countries is the
requirement for information to appear in multiple languages. Wherever practical, IMDRF encourages
the use of standardized, internationally recognized symbols as long as safe use of the device is not
compromised by diminished understanding on the part of the user. This document provides support for
the use of symbols consistent with the IMDRF objectives.
IMDRF also encourages manufacturers to employ the most appropriate methods of delivering
information. Until recently, most information had been supplied as printed materials accompanying
the IVD medical device. Modern technologies enable instructions for use and technical information
to be provided using a more efficient means of delivery. Information can be digitally encoded on
magnetic or optical media, displayed on a screen, incorporated in the device, or even transmitted over
the internet at the time of use. These advances offer users the possibility of more timely availability of
critical information, such as performance changes, and offer manufacturers more effective means of
disseminating the information.
The ISO 18113 series specifies requirements for information supplied by the manufacturer of IVD
medical devices. It consists of five parts, allowing it to address the specific needs of professional users
and self-testing users in the most appropriate manner. Furthermore, since manufacturers provide
different types of information for IVD reagents and instruments, their requirements are addressed in
separate parts of the ISO 18113 series.
This document is not intended to be used alone. It contains terms, definitions and general principles that
apply to all parts of the ISO 18113 series. While the terms and definitions in International Standards
are preferred, the terms and definitions used in the information supplied by an IVD manufacturer
should follow 4.6.2. Where synonyms are given, either term may be used but the first term is preferred.
Some definitions had to be modified for relevance to IVD labelling or to conform to ISO terminology
rules. In these cases, the source is given and indicates that the definition has been modified. In some
cases, additional notes or modifications to existing notes were needed to clarify the application to IVD
medical devices, and notes that did not apply to IVD medical devices were omitted.
v
ISO 18113-1:2022(E)
In addition, guidelines that describe the performance characteristics of IVD medical devices are given
in Annex A. This information is not repeated in the subsequent parts, therefore this document is
indispensable to the application of ISO 18113-2, ISO 18113-3, ISO 18113-4 and ISO 18113-5.
ISO 18113-2 specifies the requirements for labels and instructions for use supplied with IVD reagents,
calibrators and control materials for professional use. ISO 18113-3 specifies the requirements for labels
and instructions for use supplied with IVD instruments for professional use. ISO 18113-4 specifies the
requirements for labels and instructions for use supplied with IVD reagents, calibrators and control
materials for self-testing. ISO 18113-5 specifies the requirements for labels and instructions for use
supplied with IVD instruments for self-testing.
ISO 18113-1 (this document), ISO 18113-2 and ISO 18113-3 are the International Standards necessary
for IVD medical devices intended for medical laboratories and other professional uses; ISO 18113-1,
ISO 18113-4 and ISO 18113-5 are the International Standards necessary for IVD medical devices
intended for self-testing. However, recognizing that manufacturers often provide systems comprising
an instrument with dedicated reagents, these International Standards allow the flexibility to provide
the necessary information in the most appropriate format for the intended users, for example, a single
operator's manual for an integrated IVD medical device system.
vi
INTERNATIONAL STANDARD ISO 18113-1:2022(E)
In vitro diagnostic medical devices — Information supplied
by the manufacturer (labelling) —
Part 1:
Terms, definitions, and general requirements
1 Scope
This document defines concepts, establishes general principles, and specifies essential requirements
for information supplied by the manufacturer of IVD medical devices.
This document does not address language requirements since that is the domain of national laws and
regulations.
This document does not apply to:
a) IVD medical devices for performance evaluation (e.g. for investigational use only);
b) shipping documents;
c) material safety data sheets / Safety Data Sheets;
d) marketing information (consistent with applicable legal requirements).
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 13485, Medical devices — Quality management systems — Requirements for regulatory purposes
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 15223-1, Medical devices — Symbols to be used with information to be supplied by the manufacturer
— Part 1: General requirements
IEC 62366-1, Medical devices — Part 1: Application of usability engineering to medical devices
3 Terms and definitions
For the purposes of this document, the following terms and definitions 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/
ISO 18113-1:2022(E)
3.1 General terms and definitions for use with in vitro diagnostic medical devices
3.1.1
accessory
article intended explicitly by its manufacturer (3.1.42) to be used together with an IVD medical device
(3.1.33):
— to enable the IVD medical device (3.1.33) to achieve its intended purpose; or
— to augment or extend the capabilities of the IVD medical device (3.1.33) in the fulfilment of its
intended purpose
Note 1 to entry: Adapted from IMDRF/UDI/WG/N7, FINAL: 2013, 5.
3.1.2
advisory notice
communication issued by an organization, subsequent to delivery of a medical device (3.1.53), to provide
supplementary information and/or to advise what action should be taken in:
— the use of a medical device (3.1.53);
— the modification of a medical device (3.1.53);
— the return of a medical device (3.1.53) to the manufacturer (3.1.42);
— the destruction of a medical device (3.1.53)
Note 1 to entry: Issue of an advisory notice can be required to comply with applicable national or regional
regulations.
[SOURCE: ISO 13485:2016, 3.1, modified — “notice” has been replaced with “communication”, “or” has
been replaced with “and/or”, “return of the medical device to the organization that supplied it” has
been replaced with “return of the medical device to the manufacturer, ”]
3.1.3
aid to diagnosis IVD medical device
device used to provide additional information to assist in the determination or verification of a patient's
clinical status
Note 1 to entry: The device is not the sole determinant.
[SOURCE: GHTF/SG5/N8: 2012, Appendix Table 1, modified — “tests” has been replaced with “device” in
the definition and Note 1 to entry.]
3.1.4
analyte
component represented in the name of a measurable quantity
EXAMPLE In “the type of quantity “mass of protein in 24-hour urine”, “protein” is the analyte. In “amount of
substance of glucose in plasma”, “glucose” is the analyte . In both cases, the long phrase represents the measurand
(3.1.45)
[SOURCE: ISO 17511:2020, 3.1]
3.1.5
authorized representative
any natural or legal person established within a country or jurisdiction who has received a written
mandate from the manufacturer (3.1.42) to act on its behalf for specified tasks with regard to the latter's
obligations under that country's or jurisdiction's legislation
[54]
Note 1 to entry: In the European Union, Directive 98/79/EC and Regulation 2017/746/EU require the
manufacturer (3.1.42) to designate an “authorized representative”, established in the European Community if the
manufacturer (3.1.42) is not located in the European Community.
ISO 18113-1:2022(E)
[SOURCE: GHTF/SG1/NO55: 2009, 5.2, modified — Note 1 to entry has been added.]
3.1.6
automatic identification and data capture
AIDC
technology used to automatically capture data
Note 1 to entry: AIDC technologies include bar codes, data matrix, and radio frequency identification (RFID)
(3.1.69).
[SOURCE: IMDRF/UDI WG/N7: 2013, Clause 5, modified — “smart cards, biometrics” has been replaced
with “data matrix”.]
3.1.7
batch
lot
specified amount of material that is uniform in its properties and has been produced in one process or
series of processes
Note 1 to entry: The material can be either starting material, intermediate material, or finished product.
3.1.8
batch code
batch number
lot number
set of numbers and/or letters that specifically identifies a medical device (3.1.53) or an IVD medical
device (3.1.33) and permits its manufacturing, packaging, labelling (3.1.35) and distribution history to
be traced
Note 1 to entry: This can be referred to as the lot code, batch number, or batch code.
[52]
[SOURCE: IMDRF/GRRP WG/N52 2019, 3.20]
3.1.9
biological reference interval
reference interval
specified interval of the distribution of values taken from a biological reference population (3.1.10)
EXAMPLE The 95 % biological reference interval for sodium ion concentration values in serum from a
population of healthy male and female adults is 135 mmol/l to 145 mmol/l.
Note 1 to entry: A reference interval is commonly defined as the central 95 % interval. Another size or an
asymmetrical location of the reference interval could be more appropriate in particular cases.
Note 2 to entry: A reference interval can depend upon the type of primary samples (3.1.65) and the examination
(3.1.21) procedure used.
Note 3 to entry: In some cases, only one biological reference limit is important, for example an upper limit, “x”, so
that the corresponding biological reference interval would be less than or equal to “x”.
Note 4 to entry: Terms such as “normal range”, “normal values”, and “clinical range” are ambiguous and therefore
discouraged.
[SOURCE: ISO 15189:2012, 3.4]
3.1.10
biological reference population
reference population
group of individuals in a well-defined state of health or disease
Note 1 to entry: When biological reference intervals (3.1.9) are provided by a manufacturer (3.1.42) in the
instructions for use, laboratories using the IVD medical device (3.1.33) are responsible for verifying that the
biological reference populations represent the populations serviced by the laboratories.
ISO 18113-1:2022(E)
Note 2 to entry: A biological reference population can be a specified homogenous group of apparently healthy
individuals or individuals with a specific medical condition. The concept allows for relating the reference interval
to age, gender, and ethnicity of the reference population, as appropriate.
3.1.11
calibration
operation that, under specified conditions, in a first step, establishes a relationship between the quantity
values with measurement (3.1.46), uncertainties provided by measurement standards (3.2.36), and
corresponding measurement indications (3.2.31) with associated measurement (3.1.46) uncertainties
and, in a second step, uses this information to establish a relationship for obtaining a measurement
result (3.1.51) from an indication
Note 1 to entry: Calibration permits either the assignment of values of the measurands (3.1.44) to the measurement
indications (3.2.31) provided by the measuring instrument, or the determination of a correction with respect to
the values provided by the measuring instrument.
Note 2 to entry: Calibration is sometimes confused with adjustment of a measuring system (3.2.40), often
mistakenly called self-calibration, or with calibration verification (3.1.12).
[27]
[SOURCE: ISO/IEC Guide 99:2007, 2.39, modified — Notes 1 and 3 to entry have been deleted and
new Note 1 to entry has been added]
3.1.12
calibration verification
verification of calibration
confirmation that stated trueness claims for an IVD measuring system (3.2.40) are achieved
Note 1 to entry: Calibration verification requires reference materials (3.1.71) with assigned values at
concentrations appropriate for the intended use (3.1.37).
Note 2 to entry: Calibration verification is sometimes confused with calibration (3.1.11), linearity, verification
(3.1.92), or routine control procedures (3.1.16).
3.1.13
calibrator
measurement standard (3.2.36) used in the calibration (3.1.11) of an IVD instrument or system
[SOURCE: ISO/IEC Guide 99:2007, 5.12, modified — “calibration” has been replaced with "calibration of
an IVD instrument or system” and Note 1 to entryhas been deleted.]
3.1.14
component
part of a finished, packaged, and labelled IVD medical device (3.1.33)
EXAMPLE Raw material, substance, piece, part, software, firmware, labelling (3.1.35) or assembly.
Note 1 to entry: Typical kit (3.1.38) components include antibody solutions, buffer solutions, calibrators (3.1.13),
and/or control materials.
[SOURCE: Reference [59], c), modified — “device” has been replaced with “IVD medical device (3.1.33)”,
and Note 1 to entry has been added.]
3.1.15
control material
substance, material, or article intended by its manufacturer (3.1.42) to be used to verify the performance
characteristics (3.1.57) of an IVD medical device (3.1.33)
ISO 18113-1:2022(E)
3.1.16
control procedure
set of operations at the point of use, described specifically, intended to monitor the performance
characteristics (3.1.57) of an IVD medical device (3.1.33) and fulfil requirements for quality
Note 1 to entry: Control procedures can be intended to monitor all or part of the IVD examination (3.1.21) process,
from the collection of the sample (3.1.77) to reporting the result of the examination (3.1.21).
Note 2 to entry: Adapted from ISO 15198:2004, 3.5.
3.1.17
determination of physiological state
common test purpose or function for an in vitro diagnostic medical device (3.1.33) whereby the test
is used to evaluate the physiological state of an individual for the purpose of identifying a human
condition or characteristic
Note 1 to entry: Determination of physiological state is one of the common examination (3.1.21) purposes for IVD
medical devices (3.1.33).
Note 2 to entry: Physiological status determination tests are designed to evaluate a patient's current state.
[46]
Note 3 to entry: Adapted from GHTF/SG5/N8: 2012 , Appendix Table 1.
3.1.18
device identifier
unique device identifier-device identifier
UDI-DI
unique numeric or alphanumeric code specific to a model of medical device (3.1.53) and that is also used
as the “access key” to information stored in a unique device identifier-device identifier (UDI-DI)
EXAMPLE Include GS1 GTIN (Global Trade Item Number), HIBC-LIC (Labeler Identification Code)
[SOURCE: IMDRF/UDI WG/N7: 2013, Clause 5 modified — ISBT 128-PPIC is not included in the list of
examples.]
3.1.19
diagnostic IVD medical device
device used to determine, verify, or confirm a patient’s clinical condition as a sole determinant
Note 1 to entry: This type of examination (3.1.21) also includes sole confirmatory assays (to verify the results
of previous testing) and sole exclusion assays (to rule out a particular condition). Specimen receptacles are also
considered as in vitro diagnostic medical devices.
[46]
[SOURCE: GHTF/SG5/N8: 2012 modified — Term "examination" replaces the word ”testing".
Clarification added that specimen receptacles are in vitro diagnostic medical devices.]
3.1.20
distributor
any natural or legal person in the supply chain who, on his or her own behalf, furthers the availability of
a medical device (3.1.53) to the end user
Note 1 to entry: More than one distributor can be involved in the supply chain.
Note 2 to entry: Persons in the supply chain involved in activities such as storage and transport on behalf of the
manufacturer (3.1.42), importer (3.1.31), or distributor, are not distributors under this definition.
[47]
[SOURCE: GHTF/SG1/N055:2009, 5.3]
ISO 18113-1:2022(E)
3.1.21
examination
set of operations having the object of determining the value or characteristics of a property
Note 1 to entry: In some disciplines (e.g. microbiology) an examination is the total activity of a number of tests,
observations or measurements (3.1.46).
Note 2 to entry: Laboratory examinations that determine the value of a property are called quantitative
examinations; those that determine the characteristics of a property are called qualitative examinations.
Note 3 to entry: In clinical chemistry, laboratory examinations have been called assays or tests.
[SOURCE: ISO 15189:2012, 3.7]
3.1.22
expiry date
expiration date
upper limit of the time interval during which the performance characteristics (3.1.57) of a material
stored under specified conditions can be assured
Note 1 to entry: Expiry dates are assigned to IVD reagents (3.1.34), calibrators (3.1.13), control materials (3.1.15),
and other components (3.1.14) by the manufacturer (3.1.42), based on experimentally determined stability
(3.1.85) properties.
Note 2 to entry: Guidelines for determining the stability (3.1.85) of IVD medical devices (3.1.33) are found in
ISO 23640:2011.
3.1.23
graphical symbol
visually perceptible figure with a particular meaning used to transmit information independently of
language
[SOURCE: ISO/IEC 80416-1:2008, 3.4]
3.1.24
harm
physical injury or damage to the health of people, or damage to property or the environment
[SOURCE: ISO/IEC Guide 63:2019, 3.1, modified — Added ‘physical’ as first word in definition.]
3.1.25
hazard
potential source of harm (3.1.24)
[SOURCE: ISO/IEC Guide 63:2019, 3.2]
3.1.26
hazardous situation
circumstance in which people, property or the environment are exposed to one or more hazards (3.1.25)
Note 1 to entry: Incorrect IVD examination (3.1.21) results can contribute to a hazardous situation for a patient.
See ISO 14971, Annex C.
[SOURCE: ISO/IEC Guide 63:2019, 3.3, modified — Note 1 to entry has been added.]
3.1.27
hazardous waste
waste that is potentially harmful to human beings, property, or the environment
EXAMPLE Used reagent strips contaminated with human blood; reagent solution containing sodium azide;
decommissioned instruments containing heavy metals.
Note 1 to entry: Includes waste that is flammable, combustible, ignitable, corrosive, toxic, reactive, injurious or
infectious.
ISO 18113-1:2022(E)
[SOURCE: ISO 15190:2020, 3.14, modified — “flammable, combustible, ignitable, corrosive, toxic,
reactive, injurious or infectious has been replaced with “harmful to human beings, property”, and
EXAMPLE and Note 1 to entry have been added.]
3.1.28
healthcare provider
individual authorized to deliver health services to a patient
EXAMPLE Physician, nurse, ambulance attendant, dentist, diabetes educator, laboratory technician, medical
assistant, medical specialist, respiratory care practitioner.
3.1.29
human readable interpretation
HRI
legible interpretation of the data characters encoded in the unique device identifer carrier (3.1.88)
[50]
[SOURCE: IMDRF/UDI/ WG/N7 Final: 2013, Clause 5]
3.1.30
immediate container
primary container
packaging that protects the contents from contamination and other effects of the external environment
EXAMPLE Sealed vial, ampoule or bottle, foil pouch, sealed plastic bag.
Note 1 to entry: Does not include package liners.
3.1.31
importer
any natural or legal person who is the first in a supply chain to make a medical device (3.1.53),
manufactured in another country or jurisdiction, available in the country or jurisdiction where it is to
be marketed
Note 1 to entry: Importers are not permitted to repackage the goods or change their container, packaging, or
labelling (3.1.35) in some jurisdictions.
[47]
[SOURCE: GHTF/SG1/N055: 2009 , 5.4, modified — Note 1 to entry has been added.]
3.1.32
in vitro diagnostic instrument
IVD instrument
equipment or apparatus intended by a manufacturer (3.1.42) to be used as an IVD medical device (3.1.33)
3.1.33
in vitro diagnostic medical device
IVD medical device
medical device (3.1.53), whether used alone or in combination, intended by the manufacturer (3.1.42) for
the in vitro examination (3.1.21) of specimens (3.1.65) derived from the human body solely or principally
to provide information for diagnostic, monitoring or compatibility purposes
Note 1 to entry: IVD medical devices (3.1.33) include reagents, calibrators (3.1.13), control materials (3.1.15),
specimen (3.1.65) receptacles, software, and re
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