kSIST FprEN ISO 18113-1:2022
(Main)In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements (ISO/FDIS 18113-1:2022)
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements (ISO/FDIS 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/FDIS 18113-1:2022)
In diesem Dokument werden Konzepte definiert, allgemeine Prinzipien aufgestellt und wesentliche Anforde-rungen 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 gilt nicht für
a) In-vitro-Diagnostika zur Leistungsbewertung (z. B. nur für Forschungszwecke),
b) Verpackungslisten,
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/FDIS 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/FDIS 18113-1:2022)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 18113-1:2021
01-oktober-2021
In vitro diagnostični preskusni sistemi - Informacije proizvajalca (označevanje) - 1.
del: Izrazi, definicije in splošne zahteve (ISO/DIS 18113-1:2021)
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling)
- Part 1: Terms, definitions, and general requirements (ISO/DIS 18113-1:2021)
In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 1:
Begriffe und allgemeine Anforderungen (ISO/DIS 18113-1:2021)
Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant
(étiquetage) - Partie 1: Termes, définitions et exigences générales (ISO/DIS 18113-
1:2021)
Ta slovenski standard je istoveten z: prEN ISO 18113-1
ICS:
01.040.11 Zdravstveno varstvo Health care technology
(Slovarji) (Vocabularies)
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
oSIST prEN ISO 18113-1:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 18113-1:2021
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oSIST prEN ISO 18113-1:2021
DRAFT INTERNATIONAL STANDARD
ISO/DIS 18113-1
ISO/TC 212 Secretariat: ANSI
Voting begins on: Voting terminates on:
2021-08-02 2021-10-25
In vitro diagnostic medical devices — Information supplied
by the manufacturer (labelling) —
Part 1:
Terms, definitions, and general requirements
ICS: 11.100.10
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 18113-1:2021(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2021
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oSIST prEN ISO 18113-1:2021
ISO/DIS 18113-1:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Published in Switzerland
ii © ISO 2021 – All rights reserved
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oSIST prEN ISO 18113-1:2021
ISO/DIS 18113-1:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements for information supplied by the manufacturer.22
4.1 General .22
4.2 Language .23
4.3 Symbols and identification colours .23
4.4 Values and nomenclature .23
4.5 Microbiological state .23
4.6 Instructions for use .24
4.7 Changes to the IVD medical device .24
4.8 Disclosure of residual risks .25
4.9 Identification of components .25
4.10 Assistance .25
Annex A (informative) Performance characteristics of IVD medical devices .26
Bibliography .50
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oSIST prEN ISO 18113-1:2021
ISO/DIS 18113-1:2021(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 TC212, Clinical laboratory testing and in vitro
diagnostic test systems.
This second edition cancels and replaces the first edition (ISO 18113-1:2009), which has been technically
revised.
The main changes compared to the previous edition 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 European Union and other regulations
— Added additional detail for clarification
In this document, the following verbal forms are used: — “shall” indicates a requirement; — “should”
indicates a recommendation; — “may” indicates a permission; — “can” indicates a possibility or a
capability. Information marked as “NOTE” is for guidance in understanding or clarifying the associated
requirement.
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.
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ISO/DIS 18113-1:2021(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 could 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 [49]) 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
must be respected.
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 ISO 18113. While the terms and definitions in International Standards are
preferred, the terms and definitions used in the information supplied by an IVD manufacturer shall be
subject to the requirements of 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, a source indicates that the definition has been modified and gives
the source. 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.
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oSIST prEN ISO 18113-1:2021
ISO/DIS 18113-1:2021(E)
Common English dictionary definitions apply to non-defined concepts, such as apparatus, device,
constituent, equipment, evaluation, instrument, magnitude, material, part, phenomenon, property,
reaction, signal, substance and system.
In addition, guidelines for the terms and definitions that describe the performance characteristics of
IVD medical devices are given in Annex A. This information is not repeated in the subsequent parts,
so 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.
Parts 1, 2 and 3 of ISO 18113 are the International Standards necessary for IVD medical devices
intended for medical laboratories and other professional uses; Parts 1, 4 and 5 of ISO 18113 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.
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oSIST prEN ISO 18113-1:2021
DRAFT INTERNATIONAL STANDARD ISO/DIS 18113-1:2021(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) packaging list;
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 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 1000, SI units and recommendations for the use of their multiples and of certain other units
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 medical device labels, labelling and information to
be supplied — 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 and ISO 18113, Parts 2 – 5, the following terms and definitions apply.
ISO and IEC maintain terminological 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/
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ISO/DIS 18113-1:2021(E)
3.1
accessory
article intended explicitly by its manufacturer (3.42) to be used together with an IVD medical device
(3.33):
— to enable the IVD medical device (3.33) to achieve its intended purpose or;
— to augment or extend the capabilities of the IVD medical device (3.33) in the fulfilment of its intended
purpose.
[SOURCE: IMDRF/UDI/WG/N7, FINAL: 2013, 5, modified ─ “specifically” has been replaced with
“explicitly”, “a specific medical device” has been replaced with “an IVD medical device (3.33)”, “the
medical device (3.53)” has been replaced with “the IVD medical device (3.33)”, and “ or ─ to augment
or extend the capabilities of the IVD medical device (3.33) in the fulfilment of its intended purpose” has
been added.]
3.2
advisory notice
communication issued by an organization, subsequent to delivery of a medical device (3.52), to provide
supplementary information and/or to advise what action should be taken in:
— the use of a medical device (3.53);
— the modification of a medical device (3.53);
— the return of a medical device (3.53), to its manufacturer (3.42);
— the destruction of a medical device (3.53).
Note 1 to entry: Note to entry: Issue of an advisory notice can be required to comply with national or regional
regulations.
[SOURCE: ISO 13485:2016, 3.1]
3.3
aid to diagnosis IVD medical devices
are used to provide additional information to assist in the determination or verification of a patient's
clinical status. The assay is not the sole determinant
Note 1 to entry: Note to entry: The assay is not the sole determinant
[SOURCE: GHTF/SG5/N8: 2012, Appendix Table 1, modified ─ “Aid to diagnosis tests” has been replaced
with “aid to diagnosis in vitro diagnostic medical devices (3.53)”.]
3.4
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
(3.45)
[SOURCE: ISO 17511:2020, definition 3.2]
3.5
authorized representative
any natural or legal person established within a country or jurisdiction who has received a written
mandate from the manufacturer (3.42) to act on his behalf for specified tasks with regard to the latter's
obligations under that country's or jurisdiction's legislation
Note 1 to entry: Note to entry: In the European Union, Directive 98/79/EC [51] and Regulation 2017/746/EU
require the manufacturer (3.42) to designate an “authorized representative”, established in the European
Community if the manufacturer (3.42) is not located in the European Community
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[SOURCE: GHTF/SG1/NO55: 2009, 5.2, modified – Note to entry has been added]
3.6
automatic identification and data capture (AIDC)
a technology used to automatically capture data. AIDC technologies include bar codes, data matrix, and
radio frequency identification (RFID) (3.69)
Note 1 to entry: Note to entry: AIDC technologies include bar codes, data matrix, and radio frequency identification
(RFID)(3.69)
[SOURCE: IMDRF/UDI WG/N7: 2013, modified – “smart cards, biometrics” has been replaced with “data
matrix”]
3.7
batch
lot
defined amount of material that is uniform in its properties and has been produced in one process or
series of processes
Note 1 to entry: Note to entry: The material can be either starting material, intermediate material, or finished
product
3.8
batch code
lot number
a set of numbers and/or letters that specifically identifies a medical device (3.53) or an IVD medical
device (3.33) and permits its manufacturing, packaging, labelling (3.35) and distribution history to be
traced
Note 1 to entry: Note to entry: This can be referred to as the lot code, batch number, or batch code
[SOURCE: IMDRF/GRRP WG/N52 2019 [45], 3.20]
3.9
biological reference interval
reference interval
specified interval of the distribution of values taken from a biological reference population (3.10)
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 (3.65) and the examination
(3.20) 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, 3.4]
3.10
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 (3.9) are provided by a manufacturer (3.42) in the instructions
for use, laboratories using the IVD medical device (3.33) are responsible for verifying that the biological reference
populations represent the populations serviced by the laboratories.
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Note 2 to entry: A biological reference population can be a defined 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.
3.11
calibration
operation that, under specified conditions in a first step, establishes a relationship between the
quantity values with measurement (3.46), uncertainties provided by measurement standards (A.3.36),
and corresponding measurement indications (A.3.31) with associated measurement (3.46) uncertainties
and, in a second step, uses this information to establish a relationship for obtaining a measurement
result (3.50) from an indication
Note 1 to entry: Calibration permits either the assignment of values of the measurands (3.44) to the measurement
indications (A.3.31) 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 (A.3.40), often
mistakenly called self-calibration, or with calibration verification (3.12).
[SOURCE: ISO/IEC Guide 99:2007 [8], 2.39, modified- NOTE 1 and NOTE 3 have been deleted and new
Note 1 to entry has been added]
3.12
calibration verification
verification of calibration
confirmation that stated trueness claims for an IVD measuring system (A.3.40) are achieved
Note 1 to entry: Calibration verification requires reference materials (3.71) with assigned values at concentrations
appropriate for the intended use (3.37).
Note 2 to entry: Calibration verification is sometimes confused with calibration (3.11), linearity, verification
(3.92), or routine control procedures (3.16).
3.13
calibrator
measurement standard (A.3.36) used in the calibration (3.11) of an IVD instrument or system
[SOURCE: ISO/IEC Guide 99:2007, 5.12, modified- “calibration” has been replaced with the calibration
(3.11) of an IVD instrument or system” and NOTE has been deleted.]
3.14
component
part of a finished, packaged, and labelled IVD medical device (3.33)
EXAMPLE Raw material, substance, piece, part, software, firmware, labelling (3.35) or assembly
Note 1 to entry: Note to entry: Typical kit (3.38) components include antibody solutions, buffer solutions,
calibrators (3.13), and/or control materials
[SOURCE: U.S. Code of Federal Regulations Title 21:2019, Part 820.3, modified ─ “device” has been
replaced with “IVD medical device (3.32)”, and Note to entry has been added.]
3.15
control material
substance, material, or article intended by its manufacturer (3.42) to be used to verify the performance
characteristics (3.57) of an IVD medical device (3.33)
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3.16
control procedure
set of operations at the point of use, described specifically, intended to monitor the performance
characteristics (3.57) of an IVD medical device (3.33) and fulfil requirements for quality
Note 1 to entry: Note to entry: Control procedures can be intended to monitor all or part of the IVD examination
(3.21) process, from the collection of the sample (3.77) to reporting the result of the examination (3.21)
[SOURCE: ISO 15198:2004, 3.5, modified ─ “activities” has been replaced with “set of operations”, “to
monitor” has been replaced with” “described specifically, intended to monitor” and “the performance of
an IVD medical device (3.53)” has been replaced with “the performance characteristics of an IVD medical
device (3.53) and fulfil requirements for quality”, NOTE 1 has been deleted, and new Note to entry has
been added.]
3.17
determination of physiological state
a common test purpose or function for an in vitro diagnostic medical device (3.53) 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 (3.21) purposes for IVD
medical devices (3.33).
Note 2 to entry: Physiological status determination tests are designed to evaluate a patient's current state.
[SOURCE: GHTF/SG5/N8: 2012, Added definition, added Note 1 and Note 2 to entry from Table 1]
3.18
device identifier (UDI-DI)
a unique numeric or alphanumeric code specific to a model of medical device (3.53) and that is also used
as the “access key” to information stored in a UDID. Examples of the UDI-DI include GS1 GTIN (Global
Trade Item Number), HIBC-LIC (Labeller Identification Code)
EXAMPLE Include GS1 GTIN (Global Trade Item Number), HIBC-LIC (Labeler Identification Code)
Note 1 to entry: Determination of physiological state (3.17) is one of the common test purposes for IVD medical
devices (3.33).
Note 2 to entry: Physiological status determination tests are designed to evaluate a patient's current state.
[SOURCE: IMDRF/UDI WG/N7: 2013, 5 modified – ISBT 128-PPIC is not included in the list of examples.
Note 1 and Note 2 to entry have been added.
3.19
diagnostic IVD medical device
are used to determine, verify, or confirm a patient’s clinical condition as a sole determinant. This type
of
...
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