SIST EN ISO 18113-1:2012
(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)
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.
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
SIST EN ISO 18113-1:2012
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
SIST EN ISO 18113-1:2012 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 18113-1:2012
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SIST EN ISO 18113-1:2012
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.
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SIST EN ISO 18113-1:2012
EN ISO 18113-1:2011 (E)
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
2
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SIST EN ISO 18113-1:2012
EN ISO 18113-1:2011 (E)
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.
3
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SIST EN ISO 18113-1:2012
EN ISO 18113-1:2011 (E)
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 .
4
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SIST EN ISO 18113-1:2012
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
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SIST EN ISO 18113-1:2012
ISO 18113-1:2009(E)
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ii © ISO 2009 – All rights reserved
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SIST EN ISO 18113-1:2012
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 2009 – All rights reserved iii
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SIST EN ISO 18113-1:2012
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
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SIST EN ISO 18113-1:2012
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 2009 – All rights reserved v
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SIST EN ISO 18113-1:2012
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
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SIST EN ISO 18113-1:2012
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 2009 – All rights reserved 1
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SIST EN ISO 18113-1:2012
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
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SIST EN ISO 18113-1:2012
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 2009 – All rights reserved 3
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SIST EN ISO 18113-1:2012
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
...
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