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)

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

Overview

EN ISO 6717:2021 - In vitro diagnostic medical devices - Single‑use containers for the collection of specimens from humans other than blood - specifies requirements and test methods for specialized single‑use evacuated and non‑evacuated specimen containers used as the primary containment and preservation of non‑blood human specimens for in vitro diagnostic (IVD) examination. Examples covered include CSF, faeces, saliva, sputum, urine, tissue samples and other bodily fluids. The standard excludes containers for forensic use, cryo‑preservation, nucleic‑acid testing samples and swabs.

Keywords: EN ISO 6717:2021, in vitro diagnostic medical devices, single‑use containers, specimen collection, non‑blood specimens

Key topics and technical requirements

EN ISO 6717:2021 defines terminology, material and design expectations, and laboratory test methods. Major technical topics include:

• Materials: visibility requirements for receptacles and instructions when materials could interfere with analysis.
• Filling capacity and draw volume: definitions and tests for correct specimen/additive ratios and evacuated draw volumes (see Annex A and B).
• Graduation and fill indicators: marking requirements to enable correct filling and volume estimation.
• Design and construction: receptacle, closure and accessory definitions and performance expectations.
• Sterility and microbiological state: requirements when sterility or specific microbiological conditions are necessary.
• Additives: requirements for preservatives and reagents placed inside containers, and labelling of additive‑to‑specimen ratios.
• Marking and labelling: mandatory information, expiry date and instructions for use (referenced ISO 15223‑1 for symbols).
• Test methods: normative annexes include tests for leakage from closures (Annex C) and robustness for centrifugation (Annex D).

Applications and practical value

This standard is practical for:

• Manufacturers and product designers of IVD specimen containers - to design, verify and document container performance (capacity, closure integrity, compatibility).
• Quality and regulatory teams - to prepare technical documentation demonstrating compliance with recognized test methods and labelling requirements.
• Clinical laboratories and procurement - to specify and select containers suitable for particular specimen types and diagnostic workflows.
• Test/validation laboratories - to perform standardised tests (fill/draw volume, leakage, centrifugation robustness).

Using EN ISO 6717:2021 helps reduce pre‑analytical errors, improve sample integrity, and supports consistent specimen handling across clinical and diagnostic settings.

Related standards

• ISO 6710 - requirements and tests for single‑use human venous blood specimen containers (related blood‑specimen standard).
• ISO 15223‑1 - symbols to be used with medical device information (normative reference cited).
• Terminology references such as ISO 15189 are used for specimen definitions.

For manufacturers and laboratories working with non‑blood human specimens, EN ISO 6717:2021 is the key reference for designing, testing and labelling single‑use specimen containers.

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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
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 container
accessory (3.5) and additive (3.9), with closure (3.4) in place
[SOURCE: ISO 6710:2017, 3.4]
ISO 6717:2021(E)
3.2
evacuated container
container (3.1) intended for specimen (3.17) collection by means of evacuation, either already induced
by the manufacturer (i.e. pre-evacuated containers), or induced by the user before or during specimen
collection
[SOURCE: ISO 6710:2017, 3.7, modified — 'blood' has been replaced by 'specimen'.]
3.3
receptacle
part of the container (3.1), without the closure (3.4), that contains the specimen (3.17)
3.4
closure
component by which the container (3.1) is closed, which can consist of several parts
[SOURCE: ISO 6710:2017, 3.3, modified — 'sealed' has been replaced by 'closed' to reflect the different
types of devices and their use covered by this document.]
3.5
accessory
component inside the container (3.1) that is intended by the manufacturer to assist in the collection, or
mixing, or separation of the specimen (3.17)
[SOURCE: ISO 6710:2017, 3.1, modified — Note 1 to entry has been deleted.]
3.6
auxiliary device
device that is intended to be attached to a container (3.1) to enable sample collection to be performed
EXAMPLE Sampling spoons intended for the collection of solid specimens, or collection needles for liquid
specimens.
3.7
primary pack
smallest package of containers (3.1)
[SOURCE: ISO 6710:2017, 3.13]
3.8
container interior
inner surface of the container (3.1) exposed to the specimen (3.17)
[SOURCE: ISO 6710:2017, 3.5]
3.9
additive
substance (other than surface treatments designed to be irremovable) that is placed in the container
(3.1) in order to facilitate the preservation of the specimen (3.17), or is intended to react with the
specimen, in order to allow the intended analysis to be performed
EXAMPLE Microbiological preservatives (boric acid).
[SOURCE: ISO 6710:2017, 3.2, modified — 'inner surface' has been reduced to 'surface' and 'facilitate the
creation of the desired sample' has been replaced by 'allow the intended analysis to be performed', an
example has been added.]
2 © ISO 2021 – All rights reserved

ISO 6717:2021(E)
3.10
nominal liquid capacity
volume of specimen (3.17) with which the container (3.1) is intended to be filled plus the volume of any
additive (3.9)
Note 1 to entry: The nominal liquid capacity is stated on the label and/or the instructions for use.
Note 2 to entry: The containers defined in this document are also used to collect solid specimens. For ease of use
the capacity is defined in ml rather than cm for solid specimens. These measures may be used interchangeably.
Note 3 to entry: For certain specimen types, a range of volume is applicable rather than a specific volume.
3.11
filling capacity
volume of a liquid specimen (3.17) needed to achieve the required additive (3.9)-to-specimen ratio
3.12
fill indicator
line marked on a receptacle (3.3) or its label to indicate the correct filling
[SOURCE: ISO 6710:2017, 3.9, modified — 'tube' has been replaced by 'receptacle'.]
3.13
graduation line
mark on a receptacle (3.3), or its label, to enable an estimate of the volume of a liquid specimen (3.17)
Note 1 to entry: A receptacle can be marked by more than one graduation line.
3.14
draw volume
quantity of liquid specimen (3.17) drawn into an evacuated container (3.2)
3.15
expiry date
date after which the product shall not be used
[SOURCE: ISO 6710:2017, 3.8]
3.16
closing torque
torque, specified by the manufacturer, that is needed to tighten a screw-threaded closure (3.4)
sufficiently to affect the sealing of a receptacle (3.3)
3.17
specimen
discrete portion of a body fluid, breath, hair or tissue taken for examination, study or analysis of one or
more quantities or properties assumed to apply for the whole
[SOURCE: ISO 15189:2012, 3.16, modified – the preferred term 'primary sample' has been deleted.]
4 Materials
4.1 If the intended use requires visual inspection of the content in the receptacle, the receptacle shall
be made of material that allows a clear view of the contents when subjected to visual inspection, unless
exposure to ultraviolet light or visible light would degrade the contents.
If the receptacle is not made of material that allows a clear view of the contents, the closure may be
removed, to facilitate the examination of the contents.
ISO 6717:2021(E)
4.2 If a container is intended for the determination of a specific element/substance, e.g. trace elements,
the maximum level of the element/substance in the container interior and the analytical method
employed shall be stated by the manufacturer in the instructions for use or on the label or packaging (see
also 11.4).
For the determination of specified metals and other specified substances, the formulation of the closure
material should be such as not to interfere with the determination thereby affecting the results.
For highly sensitive determinations or specific examinations (for example those using fluorimetry) or
little-used tests, limits of interference might not have been agreed on. In such cases, the laboratory
should establish a blank value or determine the suitability of the container for the examination and/or
consult the manufacturer.
4.3 The container shall be free from foreign matter when subjected to visual inspection.
5 Filling capacity/draw volume
5.1 For non-evacuated containers intended for collection of liquid specimens, the volume of water
added shall be within ±10 % of the fi
...