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CEN/TS 17305:2019

(Main)

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA

This document gives requirements 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 is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organisations 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 technical specification. 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

Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus préanalytiques pour la salive - ADN humain extrait

Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne procese za slino - Izolirana človeška DNK

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, in regulativni organi.
V tej tehnični specifikaciji niso opisani namenski ukrepi za slino, ki je zbrana na absorbcijskem materialu ali z ustno vodo. Prav tako niso opisani ukrepi za ohranjanje in ravnanje s slini lastnim brezceličnim DNK-jem, patogeni in drugim bakterijskim ali mikrobiomskim DNK-jem 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
Withdrawn
Publication Date
02-Apr-2019
Withdrawal 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
9960 - Withdrawal effective - Withdrawal
Completion Date
03-Nov-2021
Ref Project
SIST-TS CEN/TS 17305:2019 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA

Relations

Replaced By
EN ISO 4307:2021 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO 4307:2021)
Effective Date
08-Jul-2020

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST-TS CEN/TS 17305:2019
01-julij-2019
Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne
procese za slino - Izolirani človeški DNK
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes
for saliva - Isolated human DNA
Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für
präanalytische Prozesse für Saliva - Isolierte menschliche DNS
Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus
préanalytiques pour la salive - ADN humain isolé
Ta slovenski standard je istoveten z: CEN/TS 17305:2019
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
SIST-TS CEN/TS 17305:2019 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST-TS CEN/TS 17305:2019

---------------------- Page: 2 ----------------------

SIST-TS CEN/TS 17305:2019


CEN/TS 17305
TECHNICAL SPECIFICATION

SPÉCIFICATION TECHNIQUE

April 2019
TECHNISCHE SPEZIFIKATION
ICS 11.100.10
English Version

Molecular in vitro diagnostic examinations - Specifications
for pre-examination processes for saliva - Isolated human
DNA
Analyses 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 Speichel - Isolierte menschliche DNA
This Technical Specification (CEN/TS) was approved by CEN on 21 January 2019 for provisional application.

The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to
submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard.

CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS
available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in
parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached.

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. CEN/TS 17305:2019 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

SIST-TS CEN/TS 17305:2019
CEN/TS 17305:2019 (E)
Contents Page

European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 General Considerations. 9
5 Outside the laboratory . 10
5.1 Specimen collection . 10
5.1.1 Information about the specimen donor/patient . 10
5.1.2 Selection of the saliva collection device by the laboratory . 10
5.1.3 Saliva specimen collection from the donor/patient and stabilization procedures . 10
5.1.4 Information on the specimen and storage requirements at saliva collection
facility/site .
...

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

---------------------- Page: 1 ----------------------
SIST-TS CEN/TS 17305:2019

---------------------- Page: 2 ----------------------
SIST-TS CEN/TS 17305:2019


CEN/TS 17305
TECHNICAL SPECIFICATION

SPÉCIFICATION TECHNIQUE

April 2019
TECHNISCHE SPEZIFIKATION
ICS 11.100.10
English Version

Molecular in vitro diagnostic examinations - Specifications
for pre-examination processes for saliva - Isolated human
DNA
Analyses 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 Speichel - Isolierte menschliche DNA
This Technical Specification (CEN/TS) was approved by CEN on 21 January 2019 for provisional application.

The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to
submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard.

CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS
available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in
parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached.

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. CEN/TS 17305:2019 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
SIST-TS CEN/TS 17305:2019
CEN/TS 17305:2019 (E)
Contents Page

European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 General Considerations. 9
5 Outside the laboratory . 10
5.1 Specimen collection . 10
5.1.1 Information about the specimen donor/patient . 10
5.1.2 Selection of the saliva collection device by the laboratory . 10
5.1.3 Saliva specimen collection from the donor/patient and stabilization procedures . 10
5.1.4 Information on the specimen and storage requirements at saliva collection
facility/site .
...

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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.
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