EN ISO 20186-1:2019

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA (ISO 20186-1:2019)

This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for cellular RNA examination during the pre-examination phase before a molecular examination is performed. This document covers specimens collected in venous whole blood collection tubes.
This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.
Different dedicated measures are taken for stabilizing blood cell free circulating RNA and RNA in exosomes circulating in blood. These are not described in this document.
Different dedicated measures are taken for collecting, stabilizing, transporting and storing capillary blood as well as for collecting and storing blood by paper based technologies or other technologies generating dried blood. These are not described in this document.
This document does not cover the isolation of specific blood cells and subsequent isolation of cellular RNA therefrom.
RNA in pathogens present in blood is not covered by this document.

Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für präanalytische Prozesse für venöse Vollblutproben - Teil 1: Isolierte zelluläre RNA (ISO 20186-1:2019)

Diese Internationale Norm gibt Empfehlungen zur Handhabung, Dokumentation, Lagerung und Verarbeitung von Proben venösen Vollbluts, die für die Untersuchung der zellulären RNA vorgesehen sind, während der präanalytischen Phase vor der Durchführung einer molekularen Analyse. Diese Internationale Norm betrifft Proben, die mit Blutentnahmeröhrchen für venöses Vollblut entnommen wurden.
Diese Internationale Norm ist anwendbar auf alle molekularen in vitro diagnostischen Untersuchungen, die in medizinischen Laboratorien durchgeführt werden. Sie ist darüber hinaus für die Verwendung durch Kunden von Laboratorien, Entwickler und Hersteller von In vitro Diagnostika, durch Institutionen und kommerzielle Organisationen, die biomedizinische Forschungen durchführen, sowie durch Biobanken und Arzneimittelagenturen bestimmt.
Zur Stabilisierung von im Blut zirkulierender blutzellfreier RNA und RNA in Exosomen sind andere spezielle Maßnahmen erforderlich, die in dieser Internationalen Norm nicht beschrieben werden.
Auch bei der Abnahme, Stabilisierung, dem Transport und der Lagerung von Kapillarblut sowie für die Gewinnung und Lagerung von Blut mithilfe von papierbasierten Techniken sowie anderen Techniken zur Herstellung von getrocknetem Blut sind verschiedene spezielle Maßnahmen nötig. Diese werden in dieser Internationalen Norm ebenfalls nicht beschrieben.
Diese Internationale Norm behandelt nicht die Isolierung von bestimmten Blutzellen und die anschließende Präparation von zellulärer RNA aus diesen Zellen.
Auch RNA von im Blut vorliegenden Pathogenen wird in dieser Internationalen Norm nicht behandelt.
ANMERKUNG   Internationale, nationale oder regionale Regelungen bzw. Anforderungen können ebenfalls für bestimmte Themen in dieser Internationalen Norm gelten.

Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus préanalytiques pour le sang total veineux - Partie 1: ARN cellulaire extrait (ISO 20186-1:2019)

Le présent document fournit des lignes directrices pour la manipulation, le stockage, le traitement et la documentation des prélèvements de sang total veineux destinés à l'analyse de l'ARN cellulaire durant la phase préanalytique précédant la réalisation d'un essai moléculaire. Le présent document concerne les échantillons primaires prélevés dans des tubes de prélèvement de sang total veineux.
Le présent document s'applique aux analyses de diagnostic moléculaire in vitro réalisées par des laboratoires de biologie médicale. Il est également destiné à être utilisé par des clients de laboratoires, des développeurs et fabricants de l'industrie du diagnostic in vitro, ainsi que par des biobanques, des institutions et des organismes commerciaux spécialisés en recherche biomédicale, de même que des autorités de réglementation.
Des mesures spécifiques différentes sont prises pour stabiliser l'ARN libre circulant dans le sang et l'ARN des exosomes du sang. Ces mesures ne sont pas décrites dans le présent document.
Des mesures spécifiques différentes sont prises pour prélever, stabiliser, transporter et stocker le sang capillaire, et pour prélever et stocker le sang par des technologies à base de support papier ou d'autres technologies produisant du sang séché. Ces mesures ne sont pas décrites dans le présent document.
Le présent document ne traite ni de l'extraction de cellules sanguines spécifiques ni de l'extraction de l'ARN cellulaire qu'elles contiennent.
L'ARN des pathogènes présents dans le sang n'est pas couvert par le présent document.

Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne procese za vensko polno kri - 1. del: Izolirana celična RNK (ISO 20186-1:2019)

Ta mednarodni standard vsebuje priporočila za obravnavo, dokumentiranje, shranjevanje in obdelavo vzorcev venske polne krvi, namenjenih za analizo celične RNA med predpreiskovalno fazo, preden se izvede molekularni preskus. Ta mednarodni standard zajema vzorce, ki so zbrani s cevkami za zbiranje venske polne krvi. Ta mednarodni standard se uporablja za molekularne diagnostične preiskave in vitro, vključno z laboratorijsko razvitimi preskusi, ki jih izvajajo v medicinskih laboratorijih. Uporabljali naj bi ga tudi uporabniki laboratorijev, razvijalci in proizvajalci diagnostike in vitro, nanaša pa se tudi na institucije in komercialne organizacije, ki izvajajo biomedicinske raziskave, biobanke ter regulativne organe. Profili krvne celične RNA se lahko po odvzemu krvi bistveno spremenijo. Zato je treba sprejeti posebne ukrepe za pridobivanje vzorcev krvi dobre kakovosti za analizo in shrambo celične RNA. Sprejeti je treba različne namenske ukrepe za stabiliziranje krožeče RNA brez krvnih celic in RNA v eksosomih, ki kroži v krvi, kar ni opisano v tem mednarodnem standardu. Za zbiranje, stabiliziranje, prevoz in shrambo kapilarne krvi ter za zbiranje in shrambo krvi s tehnologijami, ki temeljijo na papirju, ali drugimi tehnologijami, pri katerih nastaja posušena kri, je treba uporabiti drugačne namenske ukrepe. Ti niso opisani v tem mednarodnem standardu. RNA v patogenih v krvi ni zajeta v tem mednarodnem standardu. OPOMBA:   Za določene teme, ki so zajete v tem mednarodnem standardu, lahko veljajo tudi mednarodni, nacionalni ali regionalni predpisi ali zahteve.

General Information

• Status: Published
• Publication Date: 26-Mar-2019
• Withdrawal Date: 30-Mar-2022
• ICS: 11.100.10 - In vitro diagnostic test systems
• Technical Committee: CEN/TC 140 - In vitro diagnostic systems
• Drafting Committee: CEN/TC 140/WG 3 - Quality management in the medical laboratory
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 27-Mar-2019
• Due Date: 11-Aug-2018
• Completion Date: 27-Mar-2019
• Ref Project: SIST EN ISO 20186-1:2019 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA (ISO 20186-1:2019)

Relations

• Replaces: CEN/TS 16835-1:2015 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2019
Nadomešča:
SIST-TS CEN/TS 16835-1:2015
Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne
procese za vensko polno kri - 1. del: Izolirana celična RNA (ISO 20186-1:2019)
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes
for venous whole blood - Part 1: Isolated cellular RNA (ISO 20186-1:2019)
Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für
präanalytische Prozesse für venöse Vollblutproben - Teil 1: Isolierte zelluläre RNA (ISO
20186-1:2019)
Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus
préanalytiques pour le sang total veineux - Partie 1: ARN cellulaire extrait (ISO 20186-
1:2019)
Ta slovenski standard je istoveten z: EN ISO 20186-1:2019
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
11.100.30 Analiza krvi in urina Analysis of blood and urine
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 20186-1
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2019
EUROPÄISCHE NORM
ICS 11.100.10 Supersedes CEN/TS 16835-1:2015
English Version
Molecular in vitro diagnostic examinations - Specifications
for pre-examination processes for venous whole blood -
Part 1: Isolated cellular RNA (ISO 20186-1:2019)
Analyses de diagnostic moléculaire in vitro - Molekularanalytische in-vitro-diagnostische Verfahren
Spécifications relatives aux processus préanalytiques - Spezifikationen für präanalytische Prozesse für
pour le sang total veineux - Partie 1: ARN cellulaire venöse Vollblutproben - Teil 1: Isolierte zelluläre RNA
extrait (ISO 20186-1:2019) (ISO 20186-1:2019)
This European Standard was approved by CEN on 2 February 2019.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey 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
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 20186-1:2019 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 20186-1:2019) 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 September 2019, and conflicting national standards
shall be withdrawn at the latest by March 2022.
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 supersedes CEN/TS 16835-1:2015.
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, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 20186-1:2019 has been approved by CEN as EN ISO 20186-1:2019 without any
modification.
INTERNATIONAL ISO
STANDARD 20186-1
First edition
2019-02
Molecular in vitro diagnostic
examinations — Specifications for
pre-examination processes for venous
whole blood —
Part 1:
Isolated cellular RNA
Analyses de diagnostic moléculaire in vitro — Spécifications relatives
aux processus préanalytiques pour le sang total veineux —
Partie 1: ARN cellulaire extrait
Reference number
ISO 20186-1:2019(E)
©
ISO 2019
ISO 20186-1:2019(E)
© 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: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved

ISO 20186-1:2019(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2  Normative references . 1
3  Terms and definitions . 1
4 General considerations . 5
5 Outside the laboratory . 6
5.1 Specimen collection . 6
5.1.1 Information about the specimen donor/patient . 6
5.1.2 Selection of the venous whole blood collection tube by the laboratory . 6
5.1.3 Venous whole blood specimen collection from the donor/patient and
stabilization procedures . . 6
5.1.4 Information about the specimen and storage requirements at the blood
collection facility . 7
5.2 Transport requirements . 8
6 Inside the laboratory . 8
6.1 Specimen reception . 8
6.2 Storage requirements . 8
6.3 Isolation of the cellular RNA. 9
6.3.1 General. 9
6.3.2 Using blood collection tubes with RNA profile stabilizers . 9
6.3.3 Using blood collection tubes without RNA profile stabilizers .10
6.4 Quantity and quality assessment of isolated cellular RNA .10
6.5 Storage of isolated cellular RNA .11
6.5.1 General.11
6.5.2 Cellular RNA isolated with commercially available kits .11
6.5.3 Cellular RNA isolated with the laboratory's own protocols .11
Annex A (informative) Impact of pre-examination process steps on venous whole blood
cellular RNA profiles .12
Annex B (informative) Influence of blood storage temperature on blood cellular RNA profiles .16
Bibliography .19
ISO 20186-1:2019(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.
A list of all parts in the ISO 20186 series can be found on the ISO website.
iv © ISO 2019 – All rights reserved

ISO 20186-1:2019(E)
Introduction
Molecular in vitro diagnostics has enabled significant progress in medicine. Further progress is
expected by new technologies analysing profiles of nucleic acids, proteins, and metabolites in human
tissues and body fluids. However, the profil
...

SLOVENSKI STANDARD
01-julij-2019
Nadomešča:
SIST-TS CEN/TS 16835-1:2015
Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne
procese za vensko polno kri - 1. del: Izolirana celična RNK (ISO 20186-1:2019)
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes
for venous whole blood - Part 1: Isolated cellular RNA (ISO 20186-1:2019)
Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für
präanalytische Prozesse für venöse Vollblutproben - Teil 1: Isolierte zelluläre RNA (ISO
20186-1:2019)
Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus
préanalytiques pour le sang total veineux - Partie 1: ARN cellulaire extrait (ISO 20186-
1:2019)
Ta slovenski standard je istoveten z: EN ISO 20186-1:2019
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
11.100.30 Analiza krvi in urina Analysis of blood and urine
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 20186-1
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2019
EUROPÄISCHE NORM
ICS 11.100.10 Supersedes CEN/TS 16835-1:2015
English Version
Molecular in vitro diagnostic examinations - Specifications
for pre-examination processes for venous whole blood -
Part 1: Isolated cellular RNA (ISO 20186-1:2019)
Analyses de diagnostic moléculaire in vitro - Molekularanalytische in-vitro-diagnostische Verfahren
Spécifications relatives aux processus préanalytiques - Spezifikationen für präanalytische Prozesse für
pour le sang total veineux - Partie 1: ARN cellulaire venöse Vollblutproben - Teil 1: Isolierte zelluläre RNA
extrait (ISO 20186-1:2019) (ISO 20186-1:2019)
This European Standard was approved by CEN on 2 February 2019.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey 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
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 20186-1:2019 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 20186-1:2019) 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 September 2019, and conflicting national standards
shall be withdrawn at the latest by March 2022.
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 supersedes CEN/TS 16835-1:2015.
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, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 20186-1:2019 has been approved by CEN as EN ISO 20186-1:2019 without any
modification.
INTERNATIONAL ISO
STANDARD 20186-1
First edition
2019-02
Molecular in vitro diagnostic
examinations — Specifications for
pre-examination processes for venous
whole blood —
Part 1:
Isolated cellular RNA
Analyses de diagnostic moléculaire in vitro — Spécifications relatives
aux processus préanalytiques pour le sang total veineux —
Partie 1: ARN cellulaire extrait
Reference number
ISO 20186-1:2019(E)
©
ISO 2019
ISO 20186-1:2019(E)
© 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: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved

ISO 20186-1:2019(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2  Normative references . 1
3  Terms and definitions . 1
4 General considerations . 5
5 Outside the laboratory . 6
5.1 Specimen collection . 6
5.1.1 Information about the specimen donor/patient . 6
5.1.2 Selection of the venous whole blood collection tube by the laboratory . 6
5.1.3 Venous whole blood specimen collection from the donor/patient and
stabilization procedures . . 6
5.1.4 Information about the specimen and storage requirements at the blood
collection facility . 7
5.2 Transport requirements . 8
6 Inside the laboratory . 8
6.1 Specimen reception . 8
6.2 Storage requirements . 8
6.3 Isolation of the cellular RNA. 9
6.3.1 General. 9
6.3.2 Using blood collection tubes with RNA profile stabilizers . 9
6.3.3 Using blood collection tubes without RNA profile stabilizers .10
6.4 Quantity and quality assessment of isolated cellular RNA .10
6.5 Storage of isolated cellular RNA .11
6.5.1 General.11
6.5.2 Cellular RNA isolated with commercially available kits .11
6.5.3 Cellular RNA isolated with the laboratory's own protocols .11
Annex A (informative) Impact of pre-examination process steps on venous whole blood
cellular RNA profiles .12
Annex B (informative) Influence of blood storage temperature on blood cellular RNA profiles .16
Bibliography .19
ISO 20186-1:2019(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.
A list of all parts in the ISO 20186 series can be found on the ISO website.
iv © ISO 2019 – All rights reserved

ISO 20186-1:2019(E)
Introduction
Molecular in vitro diagnostics has enabled significant progress in medicine. Further progress is
expected by new technologies analysing profiles of nucleic acids, proteins, and metabolites in human
tissues and body fluids. However, the profiles of these molecule
...