EN ISO 18113-1:2011
(Main)In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
ISO 18113-1:2009 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) medical devices.
In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 1: Begriffe und allgemeine Anforderungen (ISO 18113-1:2009)
Dieser Teil von ISO 18113 definiert Konzepte, stellt allgemeine Prinzipien auf und legt wesentliche Anforderungen an die durch den Hersteller von In vitro Diagnostika bereitzustellenden Informationen fest.
Dieser Teil von ISO 18113 enthält keine Festlegungen zu sprachlichen Anforderungen, da es sich hierbei um den Bereich nationaler Gesetze und Vorschriften handelt.
Dieser Teil von ISO 18113 gilt nicht für
a) In vitro Diagnostika zur Leistungsbewertung (z. B. nur für Forschungszwecke),
b) Kennzeichnung von Geräten,
c) Datenblätter zur Materialsicherheit.
Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 1: Termes, définitions et exigences générales (ISO 18113-1:2009)
L'ISO 18113-1:2009 définit les concepts, établit les principes généraux et spécifie les exigences essentielles relatives aux informations fournies par le fabricant de dispositifs médicaux de DIV.
Diagnostični preskusni sistemi in vitro - Informacije proizvajalca (označevanje) - 1. del: Izrazi, definicije in splošne zahteve (ISO 18113-1:2009)
Ta del ISO 18113 definira koncepte, vzpostavlja splošna načela in določa temeljne zahteve
za informacije, ki jih priskrbi proizvajalec diagnostičnih medicinskih pripomočkov in vitro.
Ta del ISO 18113 ne obravnava jezikovnih zahtev, saj to spada na področje nacionalnih zakonov in
predpisov.
Ta del ISO 18113 ne velja za:
a) diagnostične pripomočke in vitro za ocenjevanje delovanja (npr. samo za uporabo v raziskovanju),
b) označevanje instrumentov,
c) varnostne liste za material.
General Information
Relations
Related Packages
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2012
1DGRPHãþD
SIST EN ISO 18113-1:2010
'LDJQRVWLþQLSUHVNXVQLVLVWHPLLQYLWUR,QIRUPDFLMHSURL]YDMDOFD R]QDþHYDQMH
GHO ,]UD]LGHILQLFLMHLQVSORãQH]DKWHYH ,62
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling)
- Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 1:
Begriffe und allgemeine Anforderungen (ISO 18113-1:2009)
Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant
(étiquetage) - Partie 1: Termes, définitions et exigences générales (ISO 18113-1:2009)
Ta slovenski standard je istoveten z: EN ISO 18113-1:2011
ICS:
11.100.10 'LDJQRVWLþQLSUHVNXVQL In vitro diagnostic test
VLVWHPLLQYLWUR systems
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 18113-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2011
ICS 11.100.10 Supersedes EN ISO 18113-1:2009
English Version
In vitro diagnostic medical devices - Information supplied by the
manufacturer (labelling) - Part 1: Terms, definitions and general
requirements (ISO 18113-1:2009)
Dispositifs médicaux de diagnostic in vitro - Informations In-vitro-Diagnostika - Bereitstellung von Informationen
fournies par le fabricant (étiquetage) - Partie 1: Termes, durch den Hersteller - Teil 1: Begriffe und allgemeine
définitions et exigences générales (ISO 18113-1:2009) Anforderungen (ISO 18113-1:2009)
This European Standard was approved by CEN on 20 September 2011.
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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 18113-1:2011: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of the EU Directive 98/79/EC on “in vitro Diagnostic Medical Devices” .4
Foreword
This document (EN ISO 18113-1:2011) has been prepared by Technical Committee ISO/TC 212 "Clinical
laboratory testing and in vitro diagnostic test 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 April 2012, and conflicting national standards shall be withdrawn at the
latest by October 2014.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 18113-1:2009.
This new edition contains a revised Annex ZA.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive.
For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document.
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, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and United Kingdom.
Endorsement notice
The text of ISO 18113-1:2009 has been approved by CEN as EN ISO 18113-1:2011 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of the EU Directive 98/79/EC on “in vitro Diagnostic
Medical Devices”
This European Standard has been prepared under a mandate given to CEN by the European Commission to
provide a means of conforming to the Essential Requirements of the New Approach Directive 98/79/EC on “in
vitro Diagnostic Medical Devices”.
Once this European Standard is cited in the Official Journal of the European Union under that Directive and
has been implemented as national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZA.1 confers, within the limits of the scope of this European Standard, a presumption
of conformity with the corresponding Essential Requirements of that Directive and associated EFTA
regulations.
Table ZA.1 — Correspondence between this European Standard and European Directive 98/79/EC
Clauses of this European Essential Requirements Qualifying
standard (ERs) of Directive 98/79/EC comments/Notes
Presumption of conformity with
ER B.8.1 also requires
compliance with the relevant
clauses of EN ISO 18113-2, -3,
-4 and -5, as applicable.
Compliance with MEDDEV 2.14/3
“IVD Guidance: Supply of
Instructions For Use (IFU) and
4.1, 4.2.1, 4.6 B.8.1.
other information for In vitro
Diagnostic (IVD) Medical Devices
– A Guide for Manufacturers and
Notified Bodies“ is required to
ensure presumption of conformity
in the case where IFU are
provided separately from the IVD
device.
NOTE 1
Presumption of conformity with
ER B.8.2 also requires
compliance with the relevant
4.3 B.8.2.
clauses of EN 980, where
applicable.
4.5 B.8.4(c)
4.8 B.8.4( j)
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this European Standard.
NOTE 1 MEDDEV 2.14/3 rev 1 (2007) is available from the European Commission’s website at the following
address: http://ec.europa.eu/consumers/sectors/medical-devices/files/meddev/2_14_3_rev1_ifu_final_en.pdf .
INTERNATIONAL ISO
STANDARD 18113-1
First edition
2009-12-15
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 18113-1:2009(E)
©
ISO 2009
ISO 18113-1:2009(E)
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ii © ISO 2009 – All rights reserved
ISO 18113-1:2009(E)
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.1
3 Terms and definitions .2
4 General requirements for information supplied by the manufacturer.17
4.1 General .17
4.2 Language.18
4.3 Symbols and identification colours.18
4.4 Values and nomenclature.18
4.5 Microbiological state.18
4.6 Instructions for use .18
4.7 Changes to the IVD medical device.19
4.8 Disclosure of residual risks .19
4.9 Identification of components .20
4.10 Assistance.20
Annex A (informative) Performance characteristics of IVD medical devices .21
Bibliography.45
ISO 18113-1:2009(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 18113-1 was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro
diagnostic test systems.
ISO 18113 consists of the following parts, under the general title In vitro diagnostic medical devices —
Information supplied by the manufacturer (labelling):
⎯ Part 1: Terms, definitions and general requirements
⎯ Part 2: In vitro diagnostic reagents for professional use
⎯ Part 3: In vitro diagnostic instruments for professional use
⎯ Part 4: In vitro diagnostic reagents for self-testing
⎯ Part 5: In vitro diagnostic instruments for self-testing
iv © ISO 2009 – All rights reserved
ISO 18113-1:2009(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 Global Harmonization Task Force (GHTF) 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. See Reference [36]. This
part of ISO 18113 provides a basis for harmonization of labelling requirements for IVD medical devices.
The GHTF has established guiding principles that apply to the labelling of medical devices. See Reference
[36]. These principles have been incorporated into the ISO 18113 series. Of particular note, GHTF 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 part of ISO 18113 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 recognised 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, GHTF encourages the use of
standardized, internationally recognised symbols as long as safe use of the device is not compromised by
diminished understanding on the part of the user. This part of ISO 18113 provides support for the use of
symbols consistent with the GHTF objectives.
GHTF 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 part of ISO 18113 is not intended to be used alone. It contains terms, definitions and general principles
that apply to all parts of ISO 18113. 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
ISO 18113-1:2009(E)
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, recognising 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 © ISO 2009 – All rights reserved
INTERNATIONAL STANDARD ISO 18113-1:2009(E)
In vitro diagnostic medical devices — Information supplied by
the manufacturer (labelling) —
Part 1:
Terms, definitions and general requirements
1 Scope
This part of ISO 18113 defines concepts, establishes general principles and specifies essential requirements
for information supplied by the manufacturer of IVD medical devices.
This part of ISO 18113 does not address language requirements, since that is the domain of national laws and
regulations.
This part of ISO 18113 does not apply to
a) IVD devices for performance evaluation (e.g., for investigational use only),
b) instrument marking,
c) material safety data sheets.
2 Normative references
The following referenced documents are indispensable for the application 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, Medical devices — Application of usability engineering to medical devices
EN 980, Symbols for use in the labelling of medical devices
ISO 18113-1:2009(E)
3 Terms and definitions
For the purposes of this document and ISO 18113, Parts 2-5, the following terms and definitions apply.
However, definitions provided in national and regional regulations shall take precedence. Furthermore, 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 note indicates that the definition has been adapted 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. Such cases are not
considered modifications of the definition and are not identified as “adapted”.
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.
See Annex A for additional terms and definitions that may be used by IVD manufacturers to describe
performance claims.
3.1
accessory
article intended explicitly by its manufacturer to be used together with an IVD medical device
⎯ to enable the IVD medical device to achieve its intended purpose or
⎯ to augment or extend the capabilities of the IVD medical device in the fulfilment of its intended purpose
NOTE Adapted from Reference [37], 5.0, Note 3.
3.2
advisory notice
communication issued by an organization, subsequent to delivery of a medical device, to provide
supplementary information and/or to advise what action should be taken in
⎯ the use of a medical device,
⎯ the modification of a medical device,
⎯ the return of a medical device to its manufacturer,
⎯ the destruction of a medical device
NOTE Issue of an advisory notice might be required to comply with national or regional regulations.
[ISO 13485:2003, definition 3.3]
3.3
analyte
constituent of a sample with a measurable property
EXAMPLES In “mass of protein in 24-hour urine”, “protein” is the analyte and “mass” is the property. In “concentration
of glucose in plasma”, “glucose” is the analyte and “concentration” is the property. In both cases, the full phrase
designates the measurand (3.39).
NOTE Adapted from ISO 17511:2003, definition 3.2.
2 © ISO 2009 – All rights reserved
ISO 18113-1:2009(E)
3.4
authorized representative
any natural or legal person established within a country or jurisdiction who has received a mandate from the
manufacturer to act on his behalf for specified tasks with regard to the latter's obligations under that country's
or jurisdiction's legislation
[38]
NOTE 1 In the European Union, Directive 98/79/EC requires the manufacturer to designate an “EC authorized
representative”, established in the European Community if the manufacturer is not located in the European Community.
NOTE 2 Adapted from Reference [39].
3.5
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 The material can be either starting material, intermediate material or finished product.
NOTE 2 Adapted from EN 375:2001, definition 3.2.
3.6
batch code
lot number
distinctive set of numbers and/or letters that specifically identifies a batch and permits its manufacturing,
packaging, labelling and distribution history to be traced
NOTE Adapted from EN 375:2001, definition 3.3, Reference [40], 820.3 (c), and Reference [41], Section I.
3.7
biological reference interval
reference interval
specified interval of the distribution of values taken from a biological reference population
EXAMPLE The 0,95 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 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 A reference interval can depend upon the type of primary samples and the examination procedure used.
NOTE 3 In some cases, only one biological reference limit is important, usually an upper limit, “x”, so that the
corresponding biological reference interval would be less than or equal to “x”.
NOTE 4 Terms such as “normal range”, “normal values”, and “clinical range” are ambiguous and therefore discouraged.
NOTE 5 Adapted from References [42], [43], [44] and [45].
3.8
biological reference population
reference population
group of individuals in a well-defined state of health or disease
NOTE 1 When biological reference intervals are provided by a manufacturer in the instructions for use, laboratories
using the IVD medical device are responsible for verifying that the biological reference populations represent the
populations serviced by the laboratories.
NOTE 2 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.
NOTE 3 Adapted from References [42], [43], [44] and [45].
ISO 18113-1:2009(E)
3.9
calibration
operation that, under specified conditions in a first step, establishes a relationship between the quantity values
with measurement uncertainties provided by measurement standards and corresponding measurement
indications with associated measurement uncertainties and, in a second step, uses this information to
establish a relationship for obtaining a measurement result from an indication
NOTE 1 Calibration permits either the assignment of values of the measurands to the measurement indications
provided by the measuring instrument, or the determination of a correction with respect to the values provided by the
measuring instrument.
NOTE 2 Calibration is sometimes confused with adjustment of a measuring system, often mistakenly called self-
calibration, or with calibration verification (3.10).
[ISO/IEC Guide 99:2007, definition 2.39]
3.10
calibration verification
verification of calibration
confirmation that stated trueness claims for an IVD measuring system are achieved
NOTE 1 Calibration verification requires reference materials with assigned values at concentrations appropriate for the
intended use.
NOTE 2 Calibration verification is sometimes confused with calibration (3.9), linearity verification or routine control
procedures.
3.11
calibrator
measurement standard used in the calibration of an IVD instrument or system
NOTE Adapted from ISO/IEC Guide 99:2007, 5.12.
3.12
component
part of a finished, packaged and labelled IVD medical device
EXAMPLES Raw material, substance, piece, part, software, firmware, labelling or assembly.
NOTE 1 Typical kit components include antibody solutions, buffer solutions, calibrators and/or control materials.
NOTE 2 Adapted from Reference [40], 820.3(c).
3.13
control material
substance, material or article intended by its manufacturer to be used to verify the performance characteristics
of an IVD medical device
[EN 375:2001, definition 3.5]
3.14
control procedure
set of operations at the point of use, described specifically, intended to monitor the performance
characteristics of an IVD medical device and fulfil requirements for quality
NOTE 1 Control procedures can be intended to monitor all or part of the IVD examination process, from the collection
of the sample to reporting the result of the examination.
NOTE 2 Adapted from ISO 15198:2004, definition 3.5.
4 © ISO 2009 – All rights reserved
ISO 18113-1:2009(E)
3.15
distributor
person or legal entity that furthers the marketing and/or selling of a device from the original place of
manufacture to the ultimate user without modifying the device, its packaging or its labelling
NOTE Adapted from Reference [46], 803.3 (g).
3.16
examination
set of operations having the object of determining the value or characteristics of a property
NOTE 1 In some disciplines (e.g., microbiology) an examination is the total activity of a number of tests, observations
or measurements.
NOTE 2 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 In clinical chemistry, laboratory examinations have been called assays or tests.
[ISO 15189:2007, definition 3.4]
3.17
expiry date
expiration date
upper limit of the time interval during which the performance characteristics of a material stored under
specified conditions can be assured
NOTE 1 Expiry dates are assigned to IVD reagents, calibrators, control materials and other components by the
manufacturer, based on experimentally determined stability properties (see 3.68).
NOTE 2 Guidelines for determining the stability of IVD medical devices are found in EN 13640.
NOTE 3 Adapted from EN 375:2001, definition 3.6.
3.18
graphical symbol
visually perceptible figure used to transmit information independently of language
[ISO/IEC 80416-1:2001, definition 3.1]
3.19
harm
physical injury or damage to the health of people, or damage to property or the environment
[ISO/IEC Guide 51:1999, definition 3.3]
3.20
hazard
potential source of harm
[ISO/IEC Guide 51:1999, definition 3.5]
3.21
hazardous situation
circumstance in which people, property or the environment are exposed to one or more hazards
NOTE Incorrect IVD examination results can contribute to a hazardous situation for a patient. See ISO 14971:2007,
Annex H.
[ISO/IEC Guide 51:1999, definition 3.6]
ISO 18113-1:2009(E)
3.22
hazardous waste
waste that is potentially harmful to human beings, property or the environment
EXAMPLES Used reagent strips contaminated with human blood; reagent solution containing sodium azide;
decommissioned instruments containing heavy metals.
NOTE 1 Includes waste that is flammable, combustible, ignitable, corrosive, toxic, reactive, injurious or infectious.
NOTE 2 Adapted from ISO 15190:2003, definition 3.13.
3.23
healthcare provider
individual authorized to deliver health services to a patient
EXAMPLES Physician, nurse, ambulance attendant, dentist, diabetes educator, laboratory technician, medical
assistant, medical specialist, respiratory care practitioner.
NOTE Adapted from Reference [41].
3.24
immediate container
primary container
packaging that protects the contents from contamination and other effects of the external environment
EXAMPLES Sealed vial, ampoule or bottle, foil pouch, sealed plastic bag.
NOTE Does not include package liners.
[EN 375:2001, definition 3.7]
3.25
importer
person or legal entity who brings goods, or causes goods to be brought into a country from another country
NOTE 1 Importers are not permitted to repackage the goods or change their container, packaging or labelling in some
jurisdictions, including the EU and USA.
NOTE 2 Adapted from Reference [46], 803.3 (m).
3.26
in vitro diagnostic instrument
IVD instrument
equipment or apparatus intended by a manufacturer to be used as an IVD medical device
NOTE Adapted from EN 591:2001, definition 3.5.
3.27
in vitro diagnostic medical device
IVD medical device
device, whether used alone or in combination, intended by the manufacturer for the in vitro examination of
specimens derived from the human body solely or principally to provide information for diagnostic, monitoring
or compatibility purposes and including reagents, calibrators, control materials, specimen receptacles,
software, and related instruments or apparatus or other articles
NOTE This is the definition adopted by the GHTF in [47].
6 © ISO 2009 – All rights reserved
ISO 18113-1:2009(E)
3.28
in vitro diagnostic reagent
IVD reagent
chemical, biological or immunological components, solutions or preparations intended by the manufacturer to
be used as an IVD medical device
NOTE Adapted from EN 375:2001, definition 3.9.
3.29
information supplied by the manufacturer
labelling
written, printed or graphic matter
⎯ affixed to an IVD medical device or any of its containers or wrappers or
⎯ provided for use with an IVD medical device,
related to identification and use, and giving a technical description, of the IVD medical device, but excluding
shipping documents
EXAMPLES Labels, instructions for use.
NOTE 1 In IEC standards, documents provided with a medical device and containing important information for the
responsible organization or operator, particularly regarding safety, are called “accompanying documents”.
NOTE 2 Catalogues and material safety data sheets are not considered labelling of IVD medical devices.
NOTE 3 Adapted from ISO 13485:2003, definition 3.6.
3.30
instructions for use
information supplied by the manufacturer to enable the safe and proper use of an IVD medical device
NOTE 1 Includes the directions supplied by the manufacturer for the use, maintenance, troubleshooting and disposal of
an IVD medical device, as well as warnings and precautions.
NOTE 2 Adapted from EN 376:2002, definition 3.9 and EN 591:2001, definition 3.3.
3.31
intended use
intended purpose
objective intent of an IVD manufacturer regarding the use of a product, process or service as reflected in the
specifications, instructions and information supplied by the IVD manufacturer
NOTE 1 Intended use statements for IVD labelling can include two components: a description of the functionality of the
IVD medical device (e.g., an immunochemical measurement procedure for the detection of analyte “x” in serum or plasma),
and a statement of the intended medical use of the examination results.
NOTE 2 This is the definition adopted by the GHTF in Reference [36].
3.32
kit
set of components that are packaged together and intended to be used to perform a specific IVD examination
NOTE 1 Kit components can include reagents (such as antibodies, enzymes, buffer and diluents), calibrators, controls
and other articles and materials.
NOTE 2 Adapted from EN 375:2001, definition 3.10.
ISO 18113-1:2009(E)
3.33
label
printed, written or graphic information placed on a medical device or its container
NOTE 1 A label permanently affixed to an IVD instrument is considered marking (3.37).
NOTE 2 Adapted from EN 375:2001, definition 3.12.
3.34
lay person
individual without formal training in a relevant medical field or discipline
EXAMPLE Person who performs self-testing without having a medical education.
NOTE Adapted from EN 376:2002, definintion 3.13.
3.35
limitation of the procedure
specific situation in which an IVD examination procedure might not perform as intended
NOTE 1 Factors that affect the performance of an IVD examination procedure can be physiological as well as
analytical.
NOTE 2 Adapted from Reference [48].
3.36
manufacturer
natural or legal person responsible for the design, manufacture, fabrication, assembly, packaging or labelling
of a medical device, for assembling a system, or adapting a medical device before it is placed on the market
and/or put into service, regardless of whether these operations are carried out by that person or on their
behalf by a third party
NOTE 1 Provisions of national or regional regulations could apply to the definition of manufacturer.
NOTE 2 Manufacturer includes those who perform the functions of contract sterilization, installation, relabelling,
remanufacturing, repacking or specification development, and initial distributors of foreign entities performing these
functions.
NOTE 3 A harmonized definition of "manufacturer" is being developed by the GHTF.
[ISO 14971:2007, definition 2.8]
3.37
marking
inscription, in writing or as a graphical symbol, permanently affixed to a medical device
NOTE 1 Marking is a label permanently affixed to an IVD instrument (3.26).
NOTE 2 Adapted from IEC 61010-2-101:2002, definition 3.106.
3.38
material safety data sheet
MSDS
document prepared in accordance with regulatory requirements for occupational safety to convey information
about a hazardous chemical substance
NOTE 1 Typically describes physical properties, health hazards, toxicity, fire and reactivity properties, and provides
storage and handling precautions.
NOTE 2 Material safety data sheets are not considered part of IVD medical device labelling.
NOTE 3 Adapted from Reference [49], 1910.1200 (c) and 1910.1200 (g).
8 © ISO 2009 – All rights reserved
ISO 18113-1:2009(E)
3.39
measurand
quantity intended to be measured
NOTE 1 The specification of a measurand in laboratory medicine requires knowledge of the kind of quantity (e.g., mass
concentration), a description of the matrix carrying the quantity (e.g., blood plasma), and the chemical entities involved
(e.g., the analyte).
NOTE 2 The measurand can be a biological activity.
NOTE 3 See 3.3 for other examples of IVD measurands.
NOTE 4 In chemistry, “analyte”, or the name of a substance or compound, are terms sometimes used for “measurand”.
This usage is erroneous because these terms do not refer to quantities.
[ISO/IEC Guide 99:2007, definition 2.3]
3.40
measurement
process of experimentally obtaining one or more quantity values that can reasonably be attributed to a
quantity
NOTE 1 In chemistry, “analyte”, or the name of a substance or compound, are terms sometimes used for “measurand”.
This usage is erroneous because these terms do not refer to quantities.
NOTE 2 Measurement implies comparison of quantities or counting of entities.
NOTE 3 Measurement presupposes description of the quantity commensurate with the intended use of the
measurement result, of a measurement procedure, and of a calibrated measuring system operating according to the
specified measurement.
NOTE 4 The operations can be performed automatically.
[ISO/IEC Guide 99:2007, definition 2.1]
3.41
measurement method
generic description of a logical organization of operations used in a measurement
NOTE 1 A measurement method is used in a specific measurement procedure (3.44).
NOTE 2 Measurement methods can be qualified in various ways such as direct measurement method and indirect
measurement method. See IEC 60050-300 for further information.
[ISO/IEC Guide 99:2007, definition 2.5].
3.42
measurement model
mathematical relation among all quantities known to be involved in a measurement
EXAMPLE Four-parameter logistic function for fitting sigmoidal measurement indications to calibrator concentrations
in immunochemical measurement procedures.
NOTE 1 A general form of the measurement model is the equation h(Y, X , K, X ) = 0, where Y, the output quantity in
1 n
the measurement model, is the measurand that is to be inferred from information about input quantities in the
measurement model X , K, X .
1 n
NOTE 2 In more complex cases where there are two or more output quantities, the measurement model consists of
more than one equation.
NOTE 3 In clinical chemistry, measurement models have also been called calibration models.
[ISO/IEC Guide 99:2007, 2.48]
ISO 18113-1:2009(E)
3.43
measurement principle
principle of measurement
phenomenon serving as a basis of a measurement
EXAMPLES
a) Ion selective electrode applied to the measurement of sodium activity;
b) Antibody affinity applied to the measurement of thyroid stimulating hormone (TSH) concentration;
c) Liquid chromatography applied to the measurement of digoxin concentration.
NOTE The phenomenon can be of a physical, chemical or biological nature.
[ISO/IEC Guide 99:2007, definition 2.4]
3.44
measurement procedure
detailed description of a measurement according to one or more measurement principles and to a given
measurement method, based on a measurement model and including any calculation necessary to obtain a
measurement result
NOTE 1 A measurement procedure is usually documented in sufficient detail to enable an operator to perform a
measurement.
NOTE 2 A measurement procedure can include a statement concerning a target measurement uncertainty.
[ISO/IEC Guide 99:2007, definition 2.6]
3.45
measurement result
set of quantity values being attributed to a measurand together with any other available relevant information
NOTE 1 In many fields of metrology, a measurement result is expressed as a single measured quantity value and a
measurement uncertainty. In laboratory medicine, measurement results are usually expressed as single measured
quantity values.
NOTE 2 A measurement generally provides information about the set of quantity values, such that some are more
representative of the measurand than others. This can be demonstrated in the form of a probability density function.
[81]
NOTE 3 In the traditional literature and in the previous edition of the VIM , measurement result was defined as a
value attributed to a measurand and explained to mean a measurement indication, or an uncorrected result, or a corrected
result, or an average of several values, according to the context.
[ISO/IEC Guide 99:2007, definition 2.9]
3.46
measuring interval
set of values of quantities of the same kind that can be measured by a given measuring instrument or
measuring system with specified instrumental uncertainty, under defined conditions
NOTE 1 The measuring interval over which the performance characteristics of an IVD medical device have been
validated has been called the reportable range.
NOTE 2 The lower limit of a measurement interval should not be confused with the detection limi
...
Frequently Asked Questions
EN ISO 18113-1:2011 is a standard published by the European Committee for Standardization (CEN). Its full title is "In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)". This standard covers: ISO 18113-1:2009 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) medical devices.
ISO 18113-1:2009 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) medical devices.
EN ISO 18113-1:2011 is classified under the following ICS (International Classification for Standards) categories: 11.100.10 - In vitro diagnostic test systems. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 18113-1:2011 has the following relationships with other standards: It is inter standard links to EN ISO 18113-1:2009, EN ISO 18113-1:2024. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 18113-1:2011 is associated with the following European legislation: EU Directives/Regulations: 2007/47/EC, 98/79/EC; Standardization Mandates: M/252. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
You can purchase EN ISO 18113-1:2011 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
The standard EN ISO 18113-1:2011 offers a comprehensive framework for the information supplied by manufacturers of in vitro diagnostic (IVD) medical devices. Its scope is focused on defining key concepts, establishing general principles, and specifying essential requirements that are critical for the effective understanding and use of labeling associated with these devices. This ensures that stakeholders, including healthcare professionals and end-users, have access to clear and relevant information regarding IVD products. One of the significant strengths of EN ISO 18113-1:2011 is its emphasis on clarity and comprehensibility of labeling information. By setting foundational definitions and requirements, the standard aids manufacturers in creating user-friendly labels that enhance the safe and effective use of IVD medical devices. This clarity not only promotes better decision-making in clinical settings but also aligns with regulatory frameworks, reinforcing the relevance of the standard in today's healthcare landscape. The standard’s general requirements address various aspects of labeling, including important details such as intended use, safety warnings, and proper handling instructions. Thus, it encourages manufacturers to consider user needs and environmental factors when developing labeling practices, which adds to the practicality and applicability of the standard in real-world scenarios. Furthermore, EN ISO 18113-1:2011 is aligned with international regulatory expectations, thus facilitating compliance for manufacturers looking to enter or operate within different markets. The harmonization of labeling requirements enhances the overall quality and safety of IVD medical devices, which is paramount in protecting patient health and ensuring effective diagnostics. Overall, EN ISO 18113-1:2011 stands out as a vital standard that not only guides manufacturers in providing essential information but also supports healthcare providers in making informed choices regarding IVD medical devices. Its relevance in the industry cannot be overstated, as it directly contributes to improved patient outcomes through enhanced communication and understanding surrounding these critical medical tools.
La norme SIST EN ISO 18113-1:2012, basée sur ISO 18113-1:2009, aborde des concepts essentiels relatifs à la documentation fournie par le fabricant des dispositifs médicaux de diagnostic in vitro (IVD). La portée de cette norme est significative, car elle définit des termes, établit des principes généraux et spécifie des exigences fondamentales de l'information de marquage des dispositifs IVD. Un des points forts de cette norme est sa capacité à standardiser les informations fournies par les fabricants, ce qui permet d'assurer une cohérence et une clarté dans la communication avec les utilisateurs finaux. Cela inclut des clarifications sur le contenu des étiquettes, des notices et d'autres formes de documentation qui accompagnent les dispositifs. Par conséquent, cela contribue à une meilleure compréhension des produits IVD et améliore la sécurité des patients en garantissant que toutes les informations nécessaires sont accessibles et compréhensibles. La norme revêt également une grande pertinence dans le contexte réglementaire actuel, où la conformité et la sécurité des dispositifs médicaux sont sous une surveillance accrue. En suivant les exigences établies dans le document, les fabricants peuvent mieux aligner leurs produits sur les attentes des autorités compétentes, minimisant ainsi les risques de litiges ou de rappels de produits. En résumé, la SIST EN ISO 18113-1:2012 offre un cadre robuste pour la fourniture d'informations concernant les dispositifs médicaux de diagnostic in vitro, en consolidant la confiance des utilisateurs et en promouvant des standards élevés dans le domaine des soins de santé.
Die Norm EN ISO 18113-1:2011 befasst sich mit der Bereitstellung von Informationen durch den Hersteller von In-vitro-Diagnosetests. Sie definiert grundlegende Begriffe und allgemeine Anforderungen, die sicherstellen, dass medizinische Geräte effizient und sicher verwendet werden können. Der Geltungsbereich dieser Norm ist umfassend und zielgerichtet, da sie grundlegende Prinzipien und wesentliche Anforderungen für die Kennzeichnung von In-vitro-Diagnosegeräten festlegt. Dies trägt dazu bei, die Transparenz und Verständlichkeit der bereitgestellten Informationen zu verbessern, was sowohl für Fachleute als auch für Endnutzer von entscheidender Bedeutung ist. Ein besonderer Stärke der Norm ist ihre Klarheit in den definierten Begriffen, die eine einheitliche Sprache in der Branche fördert. Durch die Standardisierung dieser Begriffe wird die Kommunikation zwischen Herstellern, Regulierungsbehörden und Nutzern effektiver, was in der Regel zu einer höheren Sicherheit und Zuverlässigkeit bei der Anwendung von IVD-Geräten führt. Die Relevanz der EN ISO 18113-1:2011 kann nicht hoch genug eingeschätzt werden, insbesondere im Kontext der globalen Gesundheitsversorgung. Mit der Möglichkeit, klare und präzise Informationen bereitzustellen, leistet die Norm einen wesentlichen Beitrag dazu, die Qualität der Diagnosetests zu gewährleisten. Sie ist unverzichtbar für die Einhaltung von regulatorischen Anforderungen und unterstützt die Harmonisierung der Produktionsstandards weltweit. Insgesamt bietet die EN ISO 18113-1:2011 eine starke Grundlage für die Kennzeichnung von In-vitro-Diagnosetests durch ihre umfassenden Definitionen, klaren Prinzipien und wichtigen Anforderungen. Die Implementierung dieser Norm ist daher für Hersteller von IVD-Geräten von großer Bedeutung, um die Sicherheit und Effizienz ihrer Produkte im Markt zu gewährleisten.
EN ISO 18113-1:2011の標準は、体外診断医療機器に関連する製造者から提供される情報の重要性を強調しています。この標準は、ISO 18113-1:2009の基本的な定義や一般的な要件を明確にし、体外診断（IVD）医療機器のラベリング情報の提供における原則を整備します。 標準の範囲は広く、製造者が提供する情報の内容、形式、適切さを規定し、消費者や医療従事者がIVD機器を安全かつ効果的に使用するために必要な情報を確保しています。この点において、EN ISO 18113-1:2011はラベリング業界において重要な役割を果たしています。 この標準の強みは、体外診断機器の情報提供における透明性を向上させることです。消費者や医療業界のプロフェッショナルにとって、明確な定義と要件は理解を助け、リスクを軽減するための基盤となります。また、製造者が準拠すべき統一された基準を提供することで、市場における競争の公平性にも寄与します。 さらに、EN ISO 18113-1:2011は国際的な基準であるため、世界中の医療機器メーカーにおいて採用されやすく、国境を越えた取引の促進にも寄与します。このことは、IVD機器に関する情報の一貫性と信頼性を高め、医療の質向上にもつながります。 全体として、EN ISO 18113-1:2011は、体外診断医療機器に関するラベリング基準における標準化の重要性を再確認させるものであり、その適用は医療業界の健全な発展に寄与するでしょう。
EN ISO 18113-1:2011 표준은 체외 진단 의료 기기의 제조자가 제공해야 하는 정보의 중요성을 명확히 규정하고 있습니다. 이 표준은 용어 정의 및 일반 요건을 통해 IVD 기기의 안전하고 효과적인 사용을 돕는 기본 틀을 제공합니다. 표준의 범위는 제조자가 제공해야 하는 정보를 체계적으로 설명하며, 이는 의료기기 사용자에게 필요한 모든 정보를 잘 전달하는 데 중점을 두고 있습니다. 이 표준의 강점 중 하나는 IVD 의료 기기에 대한 명확하고 일관된 정보 제공의 중요성을 강조한다는 점입니다. 이는 의료 종사자 및 환자 모두가 기기를 적절히 사용하고 이해하는 데 도움을 줍니다. 또한, EN ISO 18113-1:2011은 각국의 규제 당국이 요구하는 기준을 반영하여 국제적인 일관성을 유지합니다. 이는 제조자에게는 글로벌 시장 접근성을 높이고, 사용자에게는 신뢰성을 제공하는 기반이 됩니다. EN ISO 18113-1:2011의 관련성은 점점 증가하는 체외 진단 분야에서 더욱 두드러집니다. 특히 다양한 형태의 IVD 기기가 시장에 출시됨에 따라, 이러한 기기에 대한 정보의 정확성과 신뢰성은 사용자의 안전 및 진단 결과의 질을 좌우하는 필수 요소입니다. 따라서 이 표준은 제조자와 사용자 간의 효과적인 소통을 강화하고, 세계적인 의료 품질 기준을 충족하는 데 중요한 역할을 합니다. 결론적으로, EN ISO 18113-1:2011 표준은 체외 진단 의료 기기에 대한 제조자 정보의 제공 방식에 대한 명확한 지침을 제공하며, 이는 IVD 기기의 안전성과 효율성을 보장하는 데 매우 중요한 기준으로 자리잡고 있습니다.
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