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CEN

EN ISO 4307:2021

(Main)

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO 4307:2021)

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO 4307:2021)

This document specifies requirements and recommendations on the handling, storage, processing and documentation of saliva specimens intended for human DNA examination during the pre-examination phase before a molecular examination is performed.
This document is applicable to molecular in vitro diagnostic examination including laboratory developed tests performed by medical laboratories. It can also be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.
Dedicated measures that need to be taken for saliva collected on absorbing material or by mouth washes are not described in this document. Neither are measures for preserving and handling of native saliva cell-free DNA, pathogens, and other bacterial or whole microbiome DNA in saliva described.
NOTE       International, national or regional regulations or requirements can also apply to specific topics covered in this document.

Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für präanalytische Prozesse für Speichel - Isolierte menschliche DNA (ISO 4307:2021)

Dieses Dokument legt Anforderungen und Empfehlungen an die Handhabung, Lagerung, Verarbeitung und Dokumentation von für die Untersuchung von menschlicher DNA vorgesehenen Speichelproben während der präanalytischen Phase vor der Durchführung einer molekularen Analyse fest.
Dieses Dokument ist anzuwenden für molekulare in vitro-diagnostische Untersuchungen, die in medizinischen Laboratorien durchgeführt werden, einschließlich vom Laboratorium selbst entwickelter Verfahren. Es kann außerdem von Kunden des Laboratoriums, Entwicklern und Herstellern von In vitro-Diagnostika sowie Biobanken, Einrichtungen und kommerzielle Organisationen, die biomedizinische Forsch¬ungen durchführen, und Aufsichtsbehörden angewendet werden.
Spezielle Maßnahmen, die bei der Entnahme von Speichel mithilfe absorbierender Materialien oder durch Mundspülung erforderlich sind, werden in diesem Dokument nicht beschrieben. Des Weiteren sind auch keine Maßnahmen zur Konservierung und Handhabung von nativer zellfreier DNA, Pathogen- und sonstiger bakterieller oder Mikrobiom-DNA in Speichel beschrieben.
ANMERKUNG   Internationale, nationale oder regionale Regelungen bzw. Anforderungen können ebenfalls für bestimmte Themen in diesem Dokument gelten.

Analyse de diagnostic moléculaire in vitro - Spécifications relatives aux processus préanalytiques pour la salive - ADN humain extrait (ISO 4307:2021)

Le présent document spécifie les exigences et recommandations applicables à la manipulation, au stockage, au traitement et à la documentation des prélèvements de salive destinés à l’analyse de l’ADN humain durant la phase préanalytique précédant la réalisation d’une analyse moléculaire.
Le présent document est applicable aux analyses de diagnostic moléculaire in vitro, y compris les analyses développées en laboratoire réalisées par des laboratoires de biologie médicale. Il peut également être utilisé par les clients de laboratoires, les développeurs et fabricants de l’industrie du diagnostic in vitro, ainsi que par les biobanques, les institutions et les organismes commerciaux spécialisés en recherche biomédicale et les autorités réglementaires.
Les mesures dédiées qui doivent être prises pour la salive prélevée sur un matériau absorbant ou par des bains de bouche ne sont pas décrites dans le présent document. Les mesures de conservation et de manipulation de l’ADN acellulaire natif de salive, des pathogènes et d’autres ADN bactériens ou ADN de microbiome présents dans la salive ne sont pas décrites.
NOTE            Des réglementations ou exigences internationales, nationales ou régionales peuvent également s’appliquer à des sujets spécifiques traités dans le présent document.

Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne procese za slino - Izolirana človeška DNK (ISO 4307:2021)

Ta dokument podaja zahteve glede obravnave, shranjevanja, obdelave in dokumentiranja vzorcev sline, namenjenih za analizo DNK med predpreiskovalno fazo, preden se izvede molekularna preiskava.
Ta dokument se uporablja za molekularne diagnostične preiskave in vitro, vključno z laboratorijsko razvitimi preskusi, ki jih izvajajo v medicinskih laboratorijih. Namenjen je tudi temu, da ga uporabljajo laboratorijske stranke, razvijalci in proizvajalci diagnostike in vitro, biobanke, institucije in komercialne organizacije, ki izvajajo biomedicinske raziskave, ter regulativni organi.
V tem dokumentu niso opisani namenski ukrepi, ki so potrebni za slino, odvzeto z absorpcijskim materialom ali ustno vodo. Prav tako niso opisani ukrepi za ohranjanje in ravnanje s slini lastno brezcelično DNK, patogeni ter drugo bakterijsko ali mikrobiomsko DNK v slini.
OPOMBA: Za določene teme, ki so zajete v tem dokumentu, lahko veljajo tudi mednarodni, nacionalni ali regionalni predpisi ali zahteve.

General Information

Status
Published
Publication Date
02-Nov-2021
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
03-Nov-2021
Due Date
11-Apr-2023
Completion Date
03-Nov-2021
Ref Project
SIST EN ISO 4307:2022 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO 4307:2021)

Relations

Replaces
CEN/TS 17305:2019 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA
Effective Date
08-Jul-2020

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SLOVENSKI STANDARD
SIST EN ISO 4307:2022
01-januar-2022
Nadomešča:
SIST-TS CEN/TS 17305:2019
Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne
procese za slino - Izolirana človeška DNK (ISO 4307:2021)
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes
for saliva - Isolated human DNA (ISO 4307:2021)
Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für
präanalytische Prozesse für Speichel - Isolierte DNA (ISO 4307:2021)
Analyse de diagnostic moléculaire in vitro - Spécifications relatives aux processus
préanalytiques pour la salive - ADN humain extrait (ISO 4307:2021)
Ta slovenski standard je istoveten z: EN ISO 4307:2021
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
SIST EN ISO 4307:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 4307:2022

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SIST EN ISO 4307:2022


EN ISO 4307
EUROPEAN STANDARD

NORME EUROPÉENNE

November 2021
EUROPÄISCHE NORM
ICS 11.100.10 Supersedes CEN/TS 17305:2019
English Version

Molecular in vitro diagnostic examinations - Specifications
for pre-examination processes for saliva - Isolated human
DNA (ISO 4307:2021)
Analyse de diagnostic moléculaire in vitro - Molekularanalytische in-vitro-diagnostische Verfahren
Spécifications relatives aux processus préanalytiques - Spezifikationen für präanalytische Prozesse für
pour la salive - ADN humain extrait (ISO 4307:2021) Speichel - Isolierte DNA (ISO 4307:2021)
This European Standard was approved by CEN on 18 October 2021.

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, 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
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 4307:2021 E
worldwide for CEN national Members.

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SIST EN ISO 4307:2022
EN ISO 4307:2021 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 4307:2022
EN ISO 4307:2021 (E)
European foreword
This document (EN ISO 4307:2021) 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 May 2022, and conflicting national standards shall be
withdrawn at the latest by November 2024.
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 17305:2019.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia,
...

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