EN ISO 20186-1:2019
(Main)Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular 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)
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
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 20186-1:2019
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
SIST EN ISO 20186-1:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 20186-1:2019
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SIST EN ISO 20186-1:2019
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.
---------------------- Page: 3 ----------------------
SIST EN ISO 20186-1:2019
EN ISO 20186-1:2019 (E)
Contents Page
European foreword . 3
2
---------------------- Page: 4 ----------------------
SIST EN ISO 20186-1:2019
EN ISO 20186-1:2019 (E)
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,
Fran
...
SLOVENSKI STANDARD
SIST EN ISO 20186-1:2019
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
SIST EN ISO 20186-1:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 20186-1:2019
---------------------- Page: 2 ----------------------
SIST EN ISO 20186-1:2019
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.
---------------------- Page: 3 ----------------------
SIST EN ISO 20186-1:2019
EN ISO 20186-1:2019 (E)
Contents Page
European foreword . 3
2
---------------------- Page: 4 ----------------------
SIST EN ISO 20186-1:2019
EN ISO 20186-1:2019 (E)
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, Germ
...
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