EN 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

Standards Content (Sample)

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

Contents Page
European foreword . 3

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, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 4307:2021 has been approved by CEN as EN ISO 4307:2021 without any modification.

INTERNATIONAL ISO
STANDARD 4307
First edition
2021-10
Molecular in vitro diagnostic
examinations — Specifications for
pre-examination processes for saliva
— Isolated human DNA
Analyse de diagnostic moléculaire in vitro — Spécifications relatives
aux processus préanalytiques pour la salive — ADN humain extrait
Reference number
ISO 4307:2021(E)
ISO 4307:2021(E)
© ISO 2021
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]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 4307:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2  Normative references . 1
3  Terms and definitions . 1
4 General considerations .4
5 Activities outside the laboratory.5
5.1 Specimen collection . 5
5.1.1 Information about the specimen donor/patient. 5
5.1.2 Selection of the saliva collection device by the laboratory . 5
5.1.3 Saliva specimen collection from the donor/patient and stabilization
procedures . 6
5.1.4 Information on the specimen and storage requirements at saliva collection
facility/site . 7
5.2 Transport requirements . 8
5.2.1 General . 8
5.2.2 Using saliva collection devices with DNA stabilizers . 8
5.2.3 Using saliva collection devices without DNA stabilizers . 8
6 Activities inside the laboratory . 9
6.1 Specimen reception . 9
6.2 Storage requirements . 9
6.3 Isolation of the saliva DNA . 9
6.3.1 General . 9
6.3.2 Using a commercial kit . 10
6.3.3 Using the laboratory’s own protocol . 10
6.4 Quantity and quality assessment of isolated DNA . 10
6.5 Storage of isolated saliva DNA . 11
6.5.1 General . 11
6.5.2 Saliva DNA isolated with commercially available kits . 11
6.5.3 Saliva DNA isolated with the laboratory’s own protocols . 11
Bibliography .12
iii
ISO 4307:2021(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, in collaboration with the European Committee for Standardization (CEN)
Technical Committee CEN/TC 140, in vitro diagnostic medical devices, in accordance with the Agreement
on technical cooperation between ISO and CEN (Vienna Agreement).
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.
iv
ISO 4307:2021(E)
Introduction
Molecular in vitro diagnostics has enabled a significant progress in medicine. Further progress is
expected by new technologies analysing profi
...