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EN ISO 6717:2021

(Main)

In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)

In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)

This document specifies requirements and test methods for specialized single-use evacuated and non-evacuated containers, intended by their manufacturers, for the primary containment and preservation of specimens, other than blood specimens, derived from the human body, for the purposes of in vitro diagnostic examination. It is not intended to cover specimen containers for forensic investigations.
Examples of such specimens include, but are not limited to, cerebral spinal fluid (CSF), faeces, infected bodily fluids, saliva, ejaculate, sputum, urine, tissue samples.
Specimens and types of devices specifically excluded are specialized containers for cryo-preservation, samples for nucleic acid testing and swabs.
NOTE       Requirements and test methods for evacuated and non-evacuated single-use human venous blood specimen collection containers are specified in ISO 6710.
This document does not specify requirements for auxiliary devices used in conjunction with specimen containers.

In-vitro-Diagnostika - Einmalgefäße für Untersuchungsgut vom Menschen mit Ausnahme von Blutproben (ISO 6717:2021)

Dieses Dokument legt die Anforderungen und Prüfverfahren für spezielle evakuierte und nicht evakuierte Einmalgefäße fest, die von ihren Herstellern für die primäre Aufnahme und Konservierung von aus dem menschlichen Körper stammenden Proben (außer Blutproben) zum Zwecke der in vitro-diagnostischen Untersuchung vorgesehen sind. Es erstreckt sich nicht auf Probengefäße für forensische Untersuchungen.
Beispiele für solche Proben umfassen, sind aber nicht darauf beschränkt, Cerebrospinalflüssigkeit (CSF), Kot, infizierte Körperflüssigkeiten, Speichel, Ejakulat, Sputum, Urin, Gewebeproben.
Zu den Proben und Gerätetypen, die ausdrücklich ausgeschlossen sind, zählen spezielle Gefäße für die Kryokonservierung, Proben für Nukleinsäuretests und Abstrichtupfer.
ANMERKUNG   Anforderungen an und Prüfverfahren für evakuierte und nicht evakuierte Gefäße zur einmaligen Verwendung für die venöse Blutentnahme beim Menschen sind in ISO 6710 festgelegt.
Dieses Dokument legt keine Anforderungen an Hilfsvorrichtungen, die in Verbindung mit Probengefäßen verwendet werden, fest.

Dispositifs médicaux de diagnostic in vitro - Récipients à usage unique pour le prélèvement d'échantillons d'origine humaine autres que le sang (ISO 6717:2021)

Le présent document spécifie les exigences et les méthodes d’essai applicables aux récipients spécialisés à usage unique, sous vide ou non, destinés par leurs fabricants à recueillir un échantillon primaire et à conserver des échantillons provenant du corps humain, autres que le sang, aux fins d’examens de diagnostic in vitro. Il n’a pas vocation à couvrir les récipients pour des échantillons utilisés pour des enquêtes médico-légales.
Par exemple, de tels échantillons comprennent, entre autres, le liquide céphalo-rachidien (LCR), les fèces, les fluides corporels infectés, la salive, le sperme, les expectorations, l’urine et les tissus.
Les échantillons et les autres types de dispositifs spécifiquement exclus sont les récipients spéciaux dédiés à la cryoconservation, les échantillons pour les essais d’acide nucléique et les écouvillons.
NOTE            Les exigences et les méthodes d’essai pour les récipients à usage unique pour prélèvements de sang veineux humain, sous vide ou non, sont spécifiées dans l’ISO 6710.
Le présent document ne spécifie pas les exigences relatives aux dispositifs auxiliaires utilisés en combinaison avec les récipients pour prélèvements.

Diagnostični medicinski pripomočki in vitro - Posode za zbiranje vzorcev človeškega tkiva in drugih vzorcev, razen krvi, za enkratno uporabo (ISO 6717:2021)

General Information

Status
Published
Publication Date
07-Sep-2021
ICS
11.100.10 - In vitro diagnostic test systems
Technical Committee
CEN/TC 140 - In vitro diagnostic systems
Drafting Committee
CEN/TC 140 - In vitro diagnostic systems
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
08-Sep-2021
Completion Date
08-Sep-2021
Directive
98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
Mandate
M/252 - Standardization Mandate to CEN/CENELEC concerning the development of European standards relating to in vitro diagnostic medical devices
Ref Project
SIST EN ISO 6717:2021 - In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)

Relations

Replaces
EN 14254:2004 - In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans
Effective Date
08-Jun-2022

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SLOVENSKI STANDARD
SIST EN ISO 6717:2021
01-december-2021
Nadomešča:
SIST EN 14254:2005
Diagnostični medicinski pripomočki in vitro - Posode za zbiranje vzorcev
človeškega tkiva in drugih vzorcev, razen krvi, za enkratno uporabo (ISO
6717:2021)
In vitro diagnostic medical devices - Single-use containers for the collection of
specimens from humans other than blood (ISO 6717:2021)
In-vitro-Diagnostika - Einmalgefäße für Untersuchungsgut vom Menschen mit Ausnahme
von Blutproben (ISO 6717:2021)
Dispositifs médicaux de diagnostic in vitro - Récipients à usage unique pour le
prélèvement d'échantillons d'origine humaine autres que le sang (ISO 6717:2021)
Ta slovenski standard je istoveten z: EN ISO 6717:2021
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
SIST EN ISO 6717:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 6717:2021

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SIST EN ISO 6717:2021


EN ISO 6717
EUROPEAN STANDARD

NORME EUROPÉENNE

September 2021
EUROPÄISCHE NORM
ICS 11.100.10 Supersedes EN 14254:2004
English Version

In vitro diagnostic medical devices - Single-use containers
for the collection of specimens from humans other than
blood (ISO 6717:2021)
Dispositifs médicaux de diagnostic in vitro - Récipients In-vitro-Diagnostika - Einmalgefäße für
à usage unique pour le prélèvement d'échantillons Untersuchungsgut vom Menschen mit Ausnahme von
d'origine humaine autres que le sang (ISO 6717:2021) Blutproben (ISO 6717:2021)
This European Standard was approved by CEN on 1 August 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 6717:2021 E
worldwide for CEN national Members.

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SIST EN ISO 6717:2021
EN ISO 6717:2021 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 6717:2021
EN ISO 6717:2021 (E)
European foreword
This document (EN ISO 6717:2021) has been prepared by Technical Committee ISO/TC 76
"Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical
use" 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 March 2022, and conflicting national standards shall
be withdrawn at the latest by September 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 EN 14254:2004.
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 websites.
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, R
...

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