SIST 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 standard specifies requirements and test methods for single-use evacuated and non-evacuated
receptacles, 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.
NOTE 1 Requirements and test methods for evacuated and non-evacuated single-use venous blood
specimen containers are specified in EN ISO 6710.
NOTE 2 While it is desirable that specimen receptacles should be designed to avoid spontaneous
discharge of the contents, when being opened, this standard does not specify a test procedure for this
because it has not been possible to devise an objective and reproducible test.
This standard does not specify requirements for collection needles or needle holders or other
accessories used in conjunction with specimen receptacles.
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 sind unter anderem Liquor (CSF), Kot, infizierte Körperflüssigkeiten, Speichel, Sperma, 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
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, 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.
3
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SIST EN ISO 6717:2021
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SIST EN ISO 6717:2021
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
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SIST EN ISO 6717:2021
ISO 6717:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© 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: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 6717:2021
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 2021 – All rights reserved iii
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SIST EN ISO 6717:2021
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
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SIST EN ISO 6717:2021
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 2021 – All rights reserved 1
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SIST EN ISO 6717:2021
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
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SIST EN ISO 6717:2021
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
3
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 2021 – All rights reserved 3
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SIST EN ISO 6717:2021
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
...
SLOVENSKI STANDARD
oSIST prEN ISO 6717:2020
01-november-2020
Diagnostični medicinski pripomočki in vitro - Posode za zbiranje vzorcev
človeškega tkiva in drugih vzorcev, razen krvi, za enkratno uporabo (ISO/DIS
6717:2020)
In vitro diagnostic medical devices - Single-use containers for the collection of
specimens, other than blood, from humans (ISO/DIS 6717:2020)
In-vitro-Diagnostika - Einmalgefäße für Untersuchungsgut vom Menschen mit Ausnahme
von Blutproben (ISO/DIS 6717:2020)
Dispositifs médicaux de diagnostic in vitro - Récipients à usage unique pour prélèvement
humains non sanguins (ISO/DIS 6717:2020)
Ta slovenski standard je istoveten z: prEN ISO 6717
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
oSIST prEN ISO 6717:2020 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN ISO 6717:2020
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oSIST prEN ISO 6717:2020
DRAFT INTERNATIONAL STANDARD
ISO/DIS 6717
ISO/TC 76 Secretariat: DIN
Voting begins on: Voting terminates on:
2020-09-01 2020-11-24
In vitro diagnostic medical devices — Single-use
containers for the collection of specimens, other than
blood, from humans
ICS: 11.100.10
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 6717:2020(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2020
---------------------- Page: 3 ----------------------
oSIST prEN ISO 6717:2020
ISO/DIS 6717:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
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: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO 6717:2020
ISO/DIS 6717:2020(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Materials . 4
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 2020 – All rights reserved iii
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oSIST prEN ISO 6717:2020
ISO/DIS 6717:2020(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.
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 2020 – All rights reserved
---------------------- Page: 6 ----------------------
oSIST prEN ISO 6717:2020
DRAFT INTERNATIONAL STANDARD ISO/DIS 6717:2020(E)
In vitro diagnostic medical devices — Single-use
containers for the collection of specimens, other than
blood, from humans
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 are, but not limited to, cerebral spinal fluid (CSF), faeces, infected bodily
fluids, saliva, sperm, sputum, urine, tissue samples.
Specimens and types of devices specifically excluded include 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 3696, Water for analytical laboratory use — Specification and test methods
ISO 4788, Laboratory glassware — Graduated measuring cylinders
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to
be supplied — 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 (3.20), together with any container
accessory (3.5) and additive (3.9), with closure (3.4) in place
[SOURCE: ISO 6710:2017, 3.4]
© ISO 2020 – All rights reserved 1
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oSIST prEN ISO 6717:2020
ISO/DIS 6717:2020(E)
3.2
evacuated container
container (3.1) intended for specimen (3.20) 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
(3.20) 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 (3.20)
3.4
closure
component by which the container (3.1) is closed, which may 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) which is intended by the manufacturer to assist in the collection,
or mixing, or separation of the specimen (3.20)
[SOURCE: ISO 6710:2017, 3.1, modified, Note 1 to entry has been deleted.]
3.6
auxiliary devices
device that is intended to be attached to a container to enable liquid sample collection to be performed
EXAMPLE Sampling spoons intended for the collection of solid specimens, or collection needles.
3.7
primary pack
smallest package of containers (3.1)
[SOURCE: ISO 6710:2017, 3.13]
3.8
container interior
any inner surface of the container (3.1) exposed to the specimen (3.20)
[SOURCE: ISO 6710:2017, 3.5]
3.9
additive
any 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 (3.20), or is intended to react with
the specimen (3.20), in order to allow the intended analysis to be performed
EXAMPLE Microbiological preservatives (boric acid).
[SOURCE: ISO 6710:2017, 3.2, modified]
3.10
nominal liquid capacity
volume or specimen (3.20) with which the container (3.1) is intended to be filled plus the volume of any
additive (3.9)
Note 1 to entry: This volume is stated on the label and/or the instructions for use.
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oSIST prEN ISO 6717:2020
ISO/DIS 6717:2020(E)
Note 2 to entry: It is recognized that the containers defined in this document are also used to collect solid
3
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: It is recognized that for certain specimen types a range of volume is applicable rather than a
specific volume.
3.11
free space
extra capacity, or headspace, above the nominal liquid capacity (3.10)
3.12
nominal fill line
mark on a receptacle (3.3), or its label, to indicate its nominal liquid capacity (3.10)
Note 1 to entry: A receptacle can be marked with more than one fill line.
3.13
filling capacity
volume of a liquid specimen (3.20) needed to achieve the required additive to specimen (3.20) ratio
3.14
fill indicator
line marked on a receptacle (3.3) or its label to indicate the correct filling
[SOURCE: ISO 6710:2017, 3.9, modified]
3.15
graduation line
mark on a receptacle (3.3), or its label, to enable an estimate of the volume of a liquid specimen (3.20)
Note 1 to entry: A receptacle can be marked by more than one graduation line.
3.16
draw volume
quantity of liquid specimen (3.20) drawn into an evacuated container (3.2)
3.17
expiry date
date after which the container (3.1) shall not be used
[SOURCE: ISO 6710:2017, 3.8, modified]
3.18
closing torque
twisting force, specified by the manufacturer, that is required to tighten a screw-threaded closure,
sufficiently, to effect the sealing of a receptacle (3.3)
3.19
gravimetric analysis
method of determining the volume of a liquid by weighing and correcting for the mass density of the liquid
3.20
specimen
human biological material which is obtained in order to detect properties or to measure one or more
quantities
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oSIST prEN ISO 6717:2020
ISO/DIS 6717:2020(E)
4 Materials
4.1 If the intended use requires visual inspection of the content in the receptacle, the receptacle shall
be made of material which 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.
4.2 If a container is intended for the determination of a specific element/substance/examination, 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 supporting literature 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 may 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, when tested in
accordance with the methods specified in Annex A, the volume of water added shall be within ± 10 % of
the filling capacity.
5.2 For evacuated containers, the volume of water added shall be within ± 10 % of the draw volume
when tested as specified in Annex B. If ± 10 % of draw volume is not met throughout the shelf life, the
manufacturer shall ensure that correct results shall be obtained.
5.3 For containers with an additive or for containers intended for the collection of liquid suspensions
that may settle out upon standing, provision shall be made for mixing.
NOTE This document does not specify a validation procedure.
6 Graduation lines
When non-evacuated containers, of any capacity, with graduation lines are tested in accordance with
the methods specified in Annex A, the volume of water shall be from 90 % to 110 % of the volume
indicated by the graduation lines.
7 Design
7.1 The closure shall not become loose during mixing when tested for leakage in accordance with the
methods specified in Annex C or other equivalent method and no fluorescence shall be detectable in the
water in which the container has been immersed.
7.2 Where a closure is intended to be removed, it shall be designed so that it can be removed by
gripping with the fingers and/or by mechanical means, so that the part of the closure that could be in
contact with the specimen is not touched.
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oSIST prEN ISO 6717:2020
ISO/DIS 6717:2020(E)
7.3 Consideration in the design shall be given to ensure compatibility with transportation systems,
...
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