prEN ISO 20916
(Main)In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019)
In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019)
This document defines good study practice for the planning, design, conduct, recording and reporting of clinical performance studies carried out to assess the clinical performance and safety of in vitro diagnostic (IVD) medical devices for regulatory purposes.
NOTE 1 The purpose of these studies is to assess the ability of an IVD medical device in the hands of the intended user, to yield results pertaining to a particular medical condition or physiological/pathological state, in the intended population.
The document is not intended to describe whether the technical specifications of the IVD medical device in question are adequately addressed by the clinical performance study.
This document identifies the principles that underpin clinical performance studies and specifies general requirements intended to
— ensure the conduct of the clinical performance study will lead to reliable and robust study results,
— define the responsibilities of the sponsor and principal investigator,
— assist sponsors, clinical research organization, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of IVD medical devices, and
— protect the rights, safety, dignity and well-being of the subjects providing specimens for use in clinical performance studies.
Analytical performance studies are out of the scope of this document.
NOTE 2 When the collection of specimens specifically for the analytical performance study creates an additional collection risk for subjects, some of the elements of this document (particularly the annexes) can be useful for ensuring subject safety.
Clinical performance studies that are performed for reasons other than pre- and post-market regulatory purposes, such as for re-imbursement purposes, are out of the scope of this document.
NOTE 3 Some of the elements of this document can be useful for the design of such studies, including subject safety and data integrity.
This document does not include safety information for laboratory workers or other personnel collecting the study specimens.
NOTE 4 Such information is included in other publications[1][12][13].
NOTE 5 Users of this document can consider whether other standards and/or requirements also apply to the IVD medical device which is the subject of the clinical performance study, for instance, in the situation for which there is an IVD medical device and a medical device used in an integrated system (e.g. a lancet, an IVD test strip, and a glucose meter), aspects of both this document and ISO 14155 can be considered.
In-vitro-Diagnostika - Klinische Leistungsuntersuchungen an menschlichem Untersuchungsmaterial - Gute Studienpraxis (ISO 20916:2019)
Dispositifs médicaux de diagnostic in vitro - Études des performances cliniques utilisant des prélèvements de sujets humains - Bonnes pratiques d'étude (ISO 20916:2019)
Le présent document définit les bonnes pratiques pour la planification, la conception, la conduite, l'enregistrement et l'établissement du rapport d'études des performances cliniques menées en vue d'évaluer les performances cliniques et la sécurité de dispositifs médicaux de diagnostic in vitro (DIV) à des fins réglementaires.
NOTE 1 Ces études visent à évaluer la capacité d'un dispositif médical DIV, mis à disposition de l'utilisateur concerné, à produire des résultats propres à une affection particulière ou à un état physiologique/pathologique particulier, au sein de la population concernée.
Le document n'est pas destiné à décrire si les spécifications techniques du dispositif médical DIV en question sont adéquatement prises en compte ou non par l'étude des performances cliniques.
Le présent document identifie les principes étayant les études des performances cliniques et spécifie les exigences générales visant à
— assurer que la conduite de l'étude des performances cliniques donnera des résultats d'étude fiables et robustes,
— définir les responsabilités du promoteur et de l'investigateur principal,
— aider les promoteurs, les organismes de recherche clinique, les investigateurs, les comités d'éthique, les autorités réglementaires et les autres organismes impliqués dans l'évaluation de la conformité des dispositifs médicaux DIV, et
— protéger les droits, la sécurité, la dignité et le bien-être des sujets fournissant des prélèvements utilisables dans les études des performances cliniques.
Les études des performances analytiques ne font pas partie du domaine d'application du présent document.
NOTE 2 Lorsque la collecte de prélèvements spécifiques à l'étude des performances analytiques crée un risque de collecte supplémentaire pour les sujets, certains des éléments du présent document (en particulier les annexes) peuvent être utiles pour assurer la sécurité du sujet.
Les études des performances cliniques menées à des fins autres que réglementaires pré- et post-commercialisation, notamment dans le cadre d'une demande de remboursement, ne font pas partie du domaine d'application du présent document.
NOTE 3 Certains des éléments du présent document peuvent être utiles pour concevoir ces études, notamment la sécurité du sujet et l'intégrité des données.
Le présent document ne comprend pas d'informations de sécurité pour les personnels de laboratoire ou les autres personnels les prélèvements d'étude.
NOTE 4 Ces informations figurent dans d'autres publications[1][12][13].
NOTE 5 Les utilisateurs du présent document peuvent tenir compte du fait que d'autres normes et/ou exigences s'appliquent également au dispositif médical DIV qui fait l'objet de l'étude des performances cliniques ; par exemple, si un dispositif médical DIV et un dispositif médical sont utilisés dans un système intégré (par exemple, une lancette, une bandelette réactive DIV et un glucomètre), les aspects du présent document et de l'ISO 14155 peuvent être pris en considération.
Diagnostični medicinski pripomočki in vitro - Klinične študije učinkovitosti z uporabo človeških vzorcev - Dobre študijske prakse (ISO 20916:2019)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 20916:2021
01-september-2021
Diagnostični medicinski pripomočki in vitro - Klinične študije učinkovitosti z
uporabo človeških vzorcev - Dobre študijske prakse (ISO 20916:2019)
In vitro diagnostic medical devices - Clinical performance studies using specimens from
human subjects - Good study practice (ISO 20916:2019)In-vitro-Diagnostika - Klinische Leistungsuntersuchungen an menschlichem
Untersuchungsmaterial - Gute Studienpraxis (ISO 20916:2019)
Dispositifs médicaux de diagnostic in vitro - Études des performances cliniques utilisant
des prélèvements de sujets humains - Bonnes pratiques d'étude (ISO 20916:2019)Ta slovenski standard je istoveten z: prEN ISO 20916
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
oSIST prEN ISO 20916:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------oSIST prEN ISO 20916:2021
---------------------- Page: 2 ----------------------
oSIST prEN ISO 20916:2021
DRAFT
EUROPEAN STANDARD
prEN ISO 20916
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2021
ICS 11.100.10
English Version
In vitro diagnostic medical devices - Clinical performance
studies using specimens from human subjects - Good study
practice (ISO 20916:2019)
Dispositifs médicaux de diagnostic in vitro - Études des In-vitro-Diagnostika - Klinische
performances cliniques utilisant des prélèvements de Leistungsuntersuchungen an menschlichem
sujets humains - Bonnes pratiques d'étude (ISO Untersuchungsmaterial - Gute Studienpraxis (ISO
20916:2019) 20916:2019)This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 140.If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.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.Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 20916:2021 E
worldwide for CEN national Members.---------------------- Page: 3 ----------------------
oSIST prEN ISO 20916:2021
prEN ISO 20916:2021 (E)
Contents Page
European foreword ...................................................................................................................................................... 3
Annex ZA (informative) Relationship between this European Standard and the General Safety and
Performance Requirements of Regulation (EU) 2017/746 aimed to be covered ................... 4
---------------------- Page: 4 ----------------------oSIST prEN ISO 20916:2021
prEN ISO 20916:2021 (E)
European foreword
The text of ISO 20916:2019 has been prepared by Technical Committee ISO/TC 212 "Clinical laboratory
testing and in vitro diagnostic test systems” of the International Organization for Standardization (ISO)
and has been taken over as prEN ISO 20916:2021 by Technical Committee CEN/TC 140 “In vitro
diagnostic medical devices” the secretariat of which is held by DIN.This document is currently submitted to the CEN Enquiry.
This document has been prepared under a standardization request given to CEN by the European
Commission and the European Free Trade Association, and supports essential requirements of EU
Regulation(s).For relationship with EU Regulation(s), see informative Annex ZA, which is an integral part of this
document.The following referenced documents are indispensable for the application of this document. For undated
references, the latest edition of the referenced document (including any amendments) applies. For dated
references, only the edition cited applies. However, for any use of this standard “within the meaning of
Annex ZA”, the user should always check that any referenced document has not been superseded and that
its relevant contents can still be considered the generally acknowledged state-of-art.
When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version
of the ISO or IEC standard, as listed below.NOTE The way in which these references documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.Table — Correlations between normative references and dated EN and ISO standards
Normative references as listed in
Equivalent dated standard
Clause 2 of the ISO standard
EN ISO or IEC
Not applicable Not applicable Not applicable
Endorsement notice
The text of ISO 20916:2019 has been approved by CEN as prEN ISO 20916:2021 without any
modification.---------------------- Page: 5 ----------------------
oSIST prEN ISO 20916:2021
prEN ISO 20916:2021 (E)
Annex ZA
(informative)
Relationship between this European Standard and the General Safety and
Performance Requirements of Regulation (EU) 2017/746 aimed to be
covered
This European standard has been prepared under a Commission’s standardisation request [Full
reference to the request “M/xxx”] to provide one voluntary means of conforming to the General Safety
and Performance Requirements of Regulation (EU) 2017/746 of 5 April 2017 concerning in vitro
diagnostic medical devices [OJ L 117].Once this standard is cited in the Official Journal of the European Union under that Regulation, compliance
with the normative clauses of this standard given in Table ZA.1 confers, within the limits of the scope of
this standard, a presumption of conformity with the corresponding General Safety and Performance
Requirements of that Regulation, and associated EFTA regulations.NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Regulation (EU) 2017/746. This means that risks have to be
‘reduced as far as possible’, ‘reduced to a level as low as reasonably practicable’, ‘reduced to the lowest possible
level’, ‘reduced as far as possible and appropriate’, ‘removed or reduced as far as possible’, ‘eliminated or reduced
as far as possible’, ‘prevented’ or ‘minimized’, according to the wording of the corresponding General Safety and
Performance Requirement.NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety
and Performance Requirements 1, 2, 3, 4, 5, 8, 10, 11, 13, 15, 16, 17, 18 and 19 of the Regulation.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
Foreword, replacing the references in the core text.NOTE 4 When a General Safety and Performance Requirement does not appear in Table ZA.1, it means that it is
not addressed by this European Standard.Table ZA.1 — Correspondence between this European Standard and Annex I of Regulation (EU)
2017/746 [OJ L 117]General Safety and Clause(s)/sub-clause(s) of Remarks/Notes
Performance Requirements this EN
of Regulation (EU) 2017/746
2 5.2, B.7 Covered with respect to the
benefit-risk evaluation performed
during a clinical performance
study
3 (a) C.5 Covered with respect to medical
devices under clinical
investigation
3 (b) C.5 Covered with respect to medical
devices under clinical
investigation
3 (c) C.5 Covered with respect to medical
devices under clinical
investigation
---------------------- Page: 6 ----------------------
oSIST prEN ISO 20916:2021
prEN ISO 20916:2021 (E)
3 (d) C.5 Covered with respect to medical
devices under clinical
investigation
3 (e) C.5 Covered with respect to medical
devices under clinical
investigation during post market
surveillance
4 (c) C.5 Covered with respect to safety
principles and risk control
measures for devices under
clinical investigation
5 (a) C.5 Covered with respect to medical
devices under clinical
investigation
5 (b) C.5 Covered with respect to medical
devices under clinical
investigation
6 C.5, D.7.1 Covered with respect to medical
devices under clinical
investigation, especially for
companion diagnostics
8 C.5 Covered with respect to the
benefit-risk evaluation performed
during a clinical performance
study
9.1 (b) 5. 3 Covered
9.4. 5. 3 h), B.8.1 b), C.2 d) Covered with respect to clinical
performance studies
9.4. (a) 5. 3 g), 5. 3 h) Covered with respect to clinical
performance studies
9.4. (b) 5. 3 g), 5. 3 h) Covered with respect to clinical
performance studies
20.2 (e) 5. 12 Covered with respect to the
labelling of the device under
clinical performance study.
20. 3 (e) 5. 12 Covered regarding devices for
clinical performance study
20.4.1 (aa) 5.3 c) 2nd bullet point, 5.3 j) Covered with respect to
characteristics obtained during
clinical performance studies
Table ZA.2 – Correspondence between this European standard and Annex XIII of Regulation (EU)
2017/746 [OJ L 117]Requirements of Regulation Clause(s) / sub-clause(s) of
Remarks / Notes
2017/746, Annex XIII (EU) this EN
2.2 4.1, 4.3, 4.4, 5.5.2 (b), 5.5.2 (n), Covered with respect to ethical
5.5.3.17, 5.10 (c), 7.3.1 considerations
2.3.1 5.3 Covered with respect to the study
design
2.3.1 5.3 o), B.8.1 c) Covered with respect to bias
minimalization
---------------------- Page: 7 ----------------------
oSIST prEN ISO 20916:2021
prEN ISO 20916:2021 (E)
Requirements of Regulation Clause(s) / sub-clause(s) of
Remarks / Notes
2017/746, Annex XIII (EU) this EN
2.3.2 5.5.3 Covered with respect to the
content of CPSP
2.3.2 (a) 5.5.3.2 Covered with respect to the
identification of study
2.3.2 (b) 5.5.3.4 Covered with respect to the
sponsor information
2.3.2 (c) 5.9 Covered with respect to study site
identification and qualification
2.3.2 (e) 5.5.3.3, 5.5.3.8 Covered with respect to the
information of the device
2.3.2 (f) 5.5.3.9, 5.7 Covered with respect to the
specimen information
2.3.2 (g) 5.5.3.6 Covered with respect to the
summary of the study
2.3.2 (h) 5.2 Covered
2.3.2 (o) 5.10 Covered
2.3.3 8.2, Annex D Covered
Table ZA.3 – Correspondence between this European standard and Annex XIV of
Regulation (EU) 2017/746 [OJ L 117]
Requirements of Regulation Clause(s) / sub-clause(s) of
Remarks / Notes
(EU) 2017/746, Annex XIV this EN
Chapter I (1st para) 5.2 Covered with respect to risk
evaluation
Chapter I (1st para) Annex F.4 c) 3rd bullet point Covered with respect to
information provided to the
subject on the risks associated
with the interventional clinical
performance study
1.6. 5.3 Covered with respect to the
design of the clinical performance
study
1.6. 5.5.3, Annex B Covered with respect to the
content of the CPSP
1.10. 5.5.3.3 Covered
1.11. 5.5.3.6 Covered
1.12. 5.5.3.8 Covered
1.13. 5.1 3rd paragraph, 6.3 Covered with respect to
qualification evidence of the
investigator and the study site
1.13. 5.9 Covered with respect to the
capability/suitability of the site
1.17. Annex C.6 Covered with respect to the list of
applied standards and applied
essential requirements
2. Annex C Covered with respect to IB
2.5. Annex C.5 Covered
2.7. Annex C.6 a) and b) Covered with respect to the list of
applied standards and applied
essential requirements
---------------------- Page: 8 ----------------------
oSIST prEN ISO 20916:2021
prEN ISO 20916:2021 (E)
Requirements of Regulation Clause(s) / sub-clause(s) of
Remarks / Notes
(EU) 2017/746, Annex XIV this EN
3. 5.5.3 Covered with respect to the
content of the CPSP
4.1. Annex C.6 a) and b) Covered with respect to the list of
applied standards and applied
essential requirements
4.2. 6.2 f), Annex E.3 Covered
4.4. 4.5 Covered with respect to leftover
or archived specimen
4.4. Annex A.8 2nd paragraph Covered with respect to
compensation
4.4. Annex E.2 c) Covered with respect to needed
translation of the document
4.4. Annex F.2 Covered with respect to the
process for obtaining informed
consent and the provided
information
4.4. Annex F.4, Annex E.3 Covered with respect to content
of the informed consent
document
4.5. 7.4 Covered
4.6. 5.2 Covered with respect to Risk
analysis
Chapter II 1. 7.2 c) Covered with respect to sponsors
obligations to provide
information to the authorities
Chapter II 1. 7.2. g) Covered with respect to sponsors
obligations to provide
information to the authorities
Chapter II 2. Annex G Covered with respect to the
categorisation of adverse events
Chapter II 3. 8.3 Covered
Chapter II 4. 5.10 Covered with respect to the study
monitoring obligations
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
Standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European Union.
WARNING 2 — Other Union legislation may be applicable to the product(s) falling within the scope of
this standard.---------------------- Page: 9 ----------------------
oSIST prEN ISO 20916:2021
---------------------- Page: 10 ----------------------
oSIST prEN ISO 20916:2021
INTERNATIONAL ISO
STANDARD 20916
First edition
2019-05
In vitro diagnostic medical devices —
Clinical performance studies using
specimens from human subjects —
Good study practice
Dispositifs médicaux de diagnostic in vitro — Études des
performances cliniques utilisant des prélèvements de sujets humains
— Bonnes pratiques d'étude
Reference number
ISO 20916:2019(E)
ISO 2019
---------------------- Page: 11 ----------------------
oSIST prEN ISO 20916:2021
ISO 20916:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
---------------------- Page: 12 ----------------------
oSIST prEN ISO 20916:2021
ISO 20916:2019(E)
Contents Page
Foreword ..........................................................................................................................................................................................................................................v
Introduction ................................................................................................................................................................................................................................vi
1 Scope ................................................................................................................................................................................................................................. 1
2 Normative references ...................................................................................................................................................................................... 1
3 Terms and definitions ..................................................................................................................................................................................... 2
4 Ethical considerations .................................................................................................................................................................................11
4.1 General ........................................................................................................................................................................................................11
4.2 Improper influence or inducement ....................................................................................................................................11
4.3 Responsibilities ...................................................................................................................................................................................11
4.4 Ethics committee involvement ...............................................................................................................................................11
4.5 Informed consent ...............................................................................................................................................................................12
5 Clinical performance study planning ...........................................................................................................................................12
5.1 General ........................................................................................................................................................................................................12
5.2 Risk evaluation .....................................................................................................................................................................................13
5.3 Design of the clinical performance study ......................................................................................................................14
5.4 Investigator brochure.....................................................................................................................................................................14
5.5 Clinical Performance Study Protocol (CPSP) .............................................................................................................15
5.5.1 General...................................................................................................................................................................................15
5.5.2 Principal investigator responsibilities .......................................................................................................15
5.5.3 Contents of the CPSP .................................................................................................................................................16
5.6 Case report forms ..............................................................................................................................................................................19
5.7 Recording of specimen information ..................................................................................................................................20
5.8 Specimen accountability and integrity............................................................................................................................20
5.9 Study site selection ...........................................................................................................................................................................20
5.9.1 Site qualification............................................................................................................................................................20
5.9.2 Site assessment ..............................................................................................................................................................20
5.9.3 Site selection .....................................................................................................................................................................20
5.10 Monitoring plan ...................................................................................................................................................................................21
5.11 Agreements .............................................................................................................................................................................................21
5.12 Labelling ....................................................................................................................................................................................................21
6 Study site initiation .........................................................................................................................................................................................21
6.1 General ........................................................................................................................................................................................................21
6.2 Prerequisites ..........................................................................................................................................................................................22
6.3 Training ......................................................................................................................................................................................................22
6.4 Initiation of the study site ..........................................................................................................................................................22
7 Clinical performance study conduct .............................................................................................................................................23
7.1 General ........................................................................................................................................................................................................23
7.2 Responsibilities of the sponsor ..............................................................................................................................................23
7.3 Study site monitoring .....................................................................................................................................................................23
7.3.1 General...................................................................................................................................................................................23
7.3.2 Routine monitoring ....................................................................................................................................................23
7.3.3 Monitoring reports......................................................................................................................................................24
7.4 Security and confidentiality of data ...................................................................................................................................25
8 Close-out of the clinical performance study .........................................................................................................................25
8.1 Close-out activities ...........................................................................................................................................................................25
8.2 Clinical performance study report ......................................................................................................................................25
8.3 Document retention.........................................................................................................................................................................27
8.4 Suspension or premature termination of the clinical performance study .......................................27
9 Auditing .......................................................................................................................................................................................................................28
Annex A (normative) Additional general requirements for certain studies ............................................................29
© ISO 2019 – All rights reserved iii---------------------- Page: 13 ----------------------
oSIST prEN ISO 20916:2021
ISO 20916:2019(E)
Annex B (normative) Clinical performance study protocol (CPSP) ...................................................................................32
Annex C (normative) Investigator brochure ..............................................................................................................................................36
Annex D (normative) Clinical performance study report ............................................................................................................38
Annex E (normative) Communication with the ethics committee ......................................................................................41
Annex F (normative) Informed consent .........................................................................................................................................................43
Annex G (normative) Adverse event categorization ..........................................................................................................................47
Annex H (informative) Good clinical performance study documentation .................................................................51
Annex I (informative) Auditing ................................................................................................................................................................................56
Bibliography .............................................................................................................................................................................................................................57
iv © ISO 2019 – All rights reserved---------------------- Page: 14 ----------------------
oSIST prEN ISO 20916:2021
ISO 20916:2019(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/patents).Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www .iso
.org/iso/foreword .html.This document was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in
vitro diagnostic test systems.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.© ISO 2019 – All rights reserved v
---------------------- Page: 15 ----------------------
oSIST prEN ISO 20916:2021
ISO 20916:2019(E)
Introduction
In vitro diagnostic (IVD) medical devices are used to conduct tests outside of the human body to provide
valuable information regarding a person’s heal...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.