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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
European foreword . 3
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, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 6717:2021 has been approved by CEN as EN ISO 6717:2021 without any modification.
INTERNATIONAL ISO
STANDARD 6717
First edition
2021-08
In vitro diagnostic medical devices —
Single-use containers for the
collection of specimens from humans
other than blood
Dispositifs médicaux de diagnostic in vitro — Récipients à usage
unique pour le prélèvement d’échantillons d’origine humaine autres
que le sang
Reference number
ISO 6717:2021(E)
©
ISO 2021
ISO 6717:2021(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
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CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
ISO 6717:2021(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Materials . 3
5 Filling capacity/draw volume . 4
6 Graduation lines . 4
7 Design . 4
8 Construction . 5
9 Sterility and special microbiological states . 5
10 Additives. 5
11 Marking and labelling . 6
Annex A (normative) Tests for filling capacity and/or graduation lines for non-evacuated
specimen container . 8
Annex B (normative) Draw volume test for evacuated containers . 9
Annex C (normative) Test for leakage from the closure of a container .11
Annex D (normative) Test for the robustness of a container that is intended for centrifugation .13
Bibliography .14
ISO 6717:2021(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 76, Transfusion, infusion and injection,
and blood processing equipment for medical and pharmaceutical use, 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 2021 – All rights reserved
INTERNATIONAL STANDARD ISO 6717:2021(E)
In vitro diagnostic medical devices — Single-use containers
for the collection of specimens from humans other than
blood
1 Scope
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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 15223-1, Medical devices — Symbols to be used with information to be supplied by the manufacturer —
Part 1: General requirements
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
container
vessel, whether evacuated or not, intended to contain a specimen (3.17), together with any cont
...
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