SIST EN ISO 20916:2024
(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)
Dieses Dokument legt die gute Studienpraxis für die Planung, Gestaltung, Durchführung, Aufzeichnung und Meldung klinischer Leistungsuntersuchungen fest, die durchgeführt werden, um die klinische Leistungs- fähigkeit und Sicherheit von In-vitro-Diagnostika(IVD) für Zulassungszwecke zu bewerten.
ANMERKUNG1 Das Ziel dieser Untersuchungen ist es, die Fähigkeit eines In-vitro-Diagnostikums in den Händen des vorgesehenen Anwenders zu bewerten, Ergebnisse in Bezug auf eine bestimmte gesundheitliche Verfassung oder einen physiologischen/pathologischen Zustand in der vorgesehenen Population zu liefern.
Das Dokument soll nicht beschreiben, ob die technischen Spezifikationen des betreffenden In-vitro- Diagnostikums durch die klinische Leistungsuntersuchung ausreichend abgedeckt sind.
Dieses Dokument legt die Grundsätze fest, die klinischen Leistungsuntersuchungen zugrunde liegen, und gibt allgemeine Anforderungen an, die dazu dienen
—
sicherzustellen, dass die Durchführung der klinischen Leistungsuntersuchung zu zuverlässigen und soli
den Untersuchungsergebnissen führen wird,
—
die Verantwortlichkeiten des Sponsors und Prüfungsleiters festzulegen,
—
die Arbeit von Sponsoren, klinischen Forschungseinrichtungen, Prüfern, Ethikkommissionen, Arznei- mittelagenturen und anderen am Konformitätsbewertungsverfahren für In-vitro-Diagnostika beteiligten Institutionen zu unterstützen und
—
die Rechte, Sicherheit, Würde und das Wohlbefinden der Versuchspersonen zu schützen, die Untersu
chungsmaterial zur Verwendung in klinischen Leistungsuntersuchungen bereitstellen.
Analytische Leistungsuntersuchungen liegen außerhalb des Anwendungsbereiches dieses Dokuments.
ANMERKUNG2 Wenn die Entnahme von Untersuchungsmaterial speziell für die analytische Leistungsuntersuchung ein zusätzliches Entnahmerisiko für die Versuchspersonen darstellt, können einige der Elemente dieses Dokuments (ins
besondere die Anhänge) nützlich sein, um die Sicherheit der Versuchspersonen zu gewährleisten.
Klinische Leistungsuntersuchungen, die aus anderen Gründen als Zulassungszwecke vor und nach dem Inver
kehrbringen durchgeführt werden, z.B. zu Zwecken der Erstattung, fallen nicht in den Anwendungsbereich dieses Dokuments.
ANMERKUNG3 Einige der Elemente dieses Dokuments können für das Design solcher Untersuchungen nützlich sein, einschließlich der Sicherheit der Versuchspersonen und der Datenintegrität.
Dieses Dokument enthält keine Sicherheitshinweise für Labormitarbeiter oder anderes Personal, das das Untersuchungsmaterial entnimmt.
ANMERKUNG4 Diese Informationen sind in anderen Veröffentlichungen[1][12][13] enthalten.
ANMERKUNG5 Anwender dieses Dokuments können in Betracht ziehen, ob andere Normen und/oder Anforderungen auch für das In-vitro-Diagnostikum gelten, das Gegenstand der klinischen Leistungsuntersuchung ist, z.B. können in dem Fall, in dem es ein In-vitro-Diagnostikum und ein Medizinprodukt gibt, die in einem integrierten System verwendet werden (z.B. eine Lanzette, ein IVD-Teststreifen und ein Blutzuckermessgerät), Aspekte sowohl dieses Dokuments als auch von ISO14155 berücksichtigt werden.
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)
Ta dokument določa dobro študijsko prakso za načrtovanje, izvajanje, beleženje in poročanje o študijah klinične učinkovitosti, izvedenih za ocenjevanje klinične učinkovitosti in varnosti diagnostičnih medicinskih pripomočkov in vitro (IVD) za regulativne namene.
OPOMBA 1: Namen teh študij je oceniti sposobnost medicinskega pripomočka in vitro, ki ga uporablja predvideni uporabnik, da zagotovi rezultate, ki se nanašajo na posebno zdravstveno stanje ali fiziološko/patološko stanje ciljne populacije.
Dokument ni namenjen opisovanju, ali so tehnične specifikacije medicinskega pripomočka in vitro ustrezno obravnavane v študiji klinične učinkovitosti.
Ta dokument opredeljuje načela, na katerih temeljijo študije klinične učinkovitosti, in določa splošne zahteve za
– zagotavljanje, da bo izvedba študije klinične učinkovitosti dala zanesljive rezultate,
– opredelitev odgovornosti sponzorja in glavnega preiskovalca,
– pomoč sponzorjem, organizaciji za klinične raziskave, preiskovalcem, odborom za etiko, regulativnim organom in drugim organom, ki so vključeni v oceno skladnosti medicinskih pripomočkov in vitro, in
– zaščito pravic, varnosti, dostojanstva in dobrega počutja subjektov, ki zagotavljajo vzorce za uporabo v študijah klinične učinkovitosti.
Študije analitične učinkovitosti ne spadajo v področje uporabe tega dokumenta.
OPOMBA 2: Če zbiranje vzorcev posebej za študijo analitične učinkovitosti ustvarja dodatno tveganje pri zbiranju za subjekte, so lahko nekateri elementi tega dokumenta (predvsem dodatki) uporabni za zagotavljanje varnosti subjekta.
Študije klinične učinkovitosti, ki niso izvedene zaradi regulativnih namenov pred dajanjem in po dajanju na trg, na primer za namene povračila, niso zajete v področje uporabe tega dokumenta.
OPOMBA 3: Nekateri elementi tega dokumenta so lahko uporabni pri snovanju tovrstnih študij, vključno z varnostjo subjekta in celovitostjo podatkov.
Ta dokument ne vključuje informacij o varnosti za laboratorijske delavce ali drugo osebje, ki zbira vzorce za študijo.
OPOMBA 4: Te informacije so zajete v druge publikacije [1][12][13].
OPOMBA 5: Uporabniki tega dokumenta lahko preučijo, ali tudi drugi standardi in/ali zahteve veljajo za medicinski pripomoček in vitro, ki je predmet študije klinične učinkovitosti, na primer v primeru, ki vključuje medicinski pripomoček in vitro in medicinski pripomoček v integriranem sistemu (npr. lanceta, preskusni trak in vitro in merilec krvnega sladkorja), se lahko upošteva vidike iz tega dokumenta in standarda ISO 14155.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 20916:2024
01-maj-2024
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: EN ISO 20916:2024
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
SIST EN ISO 20916:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 20916:2024
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SIST EN ISO 20916:2024
EN ISO 20916
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2024
EUROPÄISCHE NORM
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 European Standard was approved by CEN on 7 August 2023.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 20916:2024 E
worldwide for CEN national Members.
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SIST EN ISO 20916:2024
EN ISO 20916:2024 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard the General Safety
and Performance Requirements of Regulation (EU) 2017/746 aimed to be covered . 4
2
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SIST EN ISO 20916:2024
EN ISO 20916:2024 (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 EN ISO 20916:2024 by 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 September 2024, and conflicting national standards
shall be withdrawn at the latest by March 2027.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document has been prepared under a standardization request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
For the relationship with EU Legislation, see informative Annex ZA, which is an integral part of this
document.
Any feedback and questions on this document should be directed to the users’ national standar
...
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.
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oSIST prEN ISO 20916:2021
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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
2
---------------------- 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
...
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