ISO 6710:2017

INTERNATIONAL ISO
STANDARD 6710
Second edition
2017-07
Single-use containers for human
venous blood specimen collection
Récipients non réutilisables pour prélèvements de sang veineux humain
Reference number
©
ISO 2017
© ISO 2017, Published in Switzerland
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ii © ISO 2017 – All rights reserved

Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Materials . 2
5 Draw volume . 3
6 Design . 3
7 Construction . 3
8 Sterility and special microbiological states . 3
9 Additives. 4
10 Marking and labelling . 4
11 Container identification . 5
Annex A (normative) Draw volume test for non-evacuated containers . 6
Annex B (normative) Draw volume test for evacuated containers . 7
Annex C (normative) Test for leakage of container. 9
Annex D (normative) Test for robustness of the container .11
Annex E (normative) Concentrations of additives and volume of liquid additives .12
Annex F (informative) Recommended colour codes for identifying additives and accessories .14
Bibliography .15
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 on 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 the following
URL: w w w . i s o .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.
This second edition cancels and replaces the first edition (ISO 6710:1995), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— the Scope has been updated and phrased clearer. Blood culture bottles have been excluded from this
document, as it does not address the special needs for this kind of testing;
— Clause 3 has been updated and extended;
— Clause 4 has been updated;
— Clause 5 has been shortened and renamed to “Draw volume”;
— Clause 6 has been updated;
— Clause 8 has been technically revised and renamed to “Sterility and special microbiological states”;
— Clause 9 has been extended;
— Clause 10 has been slightly updated to meet current general requirements (except local requirements);
— Table 1 has been extended by additional entries for additives. It has been reduced to the specified
letter codes, while the information on recommended colour codes for identifying additives has been
moved to a new Annex F (for clarification, see Introduction);
— tests in Annexes A to D have been updated in alignment with the requirements in the body of this
document;
— Annex E has been completely revised;
iv © ISO 2017 – All rights reserved

— references in Clause 2 and Bibliography have been updated.
Introduction
ISO 6710 was first published in 1995. With the first revision starting in the year 2000, the Vienna
Agreement was applied to develop the updated edition of this document in parallel between ISO and CEN.
However, in 2002 the parallel ballot on ISO 6710, respectively prEN ISO 6710, failed on ISO level.
The ongoing development was continued only on European level and led finally to the publication of
EN 14820:2004. Although, during the development, no consensus could be reached between the CEN
member states to add a specification for a common colour code for identifying containers with different
additives.
The EU commission considered the absence of colour code specifications as potential safety risk and
submitted in 2006 the standardization mandate M/384 to CEN with the request to solve the issue. But
even with this confirmed need it was not possible to find a consensus between the CEN members.
Based on a Swedish standardization proposal in 2014, this subject was raised again and led finally to
the initiation of the revision of ISO 6710:1995. The Vienna Agreement was applied in order to revise as
well EN 14820:2004 with the final goal again to develop an International Standard in parallel with a
harmonized European Standard.
During the development, it was recognized that at least recommendations for appropriate colour code
specifications should be amended. In order to avoid further disputes on this subject, it was decided
to add these recommendations in Annex F. This provides the potential users the possibility of a
smooth implementation of the colour code identification without being under pressure to comply with
this document in this subject. This way of introducing a common colour code allows manufacturers
and/or users in healthcare to grant an evaluation phase. If there will be a higher acceptance after the
publication of this document, with the next revision there is the intention to possibly move the content
of Annex F to the normative part of this document.
In some countries, the national pharmacopoeia or other national regulations are legally binding and
take precedence over this document.
vi © ISO 2017 – All rights reserved

INTERNATIONAL STANDARD ISO 6710:2017(E)
Single-use containers for human venous blood specimen
collection
1 Scope
This document specifies requirements and test methods for evacuated and non-evacuated single-use
venous blood specimen containers.
It does not specify requirements for blood collection needles, needle holders, blood culture receptacles
or “arterial” blood gas collection devices that can be used for venous blood.
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 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:
— IEC Electropedia: available at http:// www .electropedia .org/
— ISO Online browsing platform: available at http:// www .iso .org/ obp
3.1
accessory
component inside the container (3.4) which is intended by the manufacturer to assist in the collection,
or mixing, or separation of the specimen (3.15)
Note 1 to entry: Examples of accessories are small plastic inert balls or a separate gel found in a serum or plasma
container designed to separate the serum or plasma from the cells after centrifugation.
3.2
additive
substance (other than inside surface treatments designed to be irremovable) that is placed in the
container (3.4) in order to facilitate the creation of the desired sample
3.3
closure
component by which the container (3.4) is sealed, which may consist of several parts
3.4
container
vessel, whether evacuated or not, intended to contain a specimen (3.15), together with any container
accessory (3.1) and additive (3.2), with closure (3.3) in place
3.5
container interior
inner surface of the container (3.4) exposed to the specimen (3.15)
3.6
draw volume
volume of whole blood that will be collected in the container (3.4)
3.7
evacuated container
container (3.4) intended for blood collection by means of evacuation either already induced by the
manufacturer (i.e. pre-evacuated containers) or induced by the user before or during blood collection
3.8
expiry date
date after which the product shall not be used
3.9
fill indicator
line marked on a tube (3.16) or its label to indicate the correct filling
3.10
free space
space above the drawn sample
3.11
nominal liquid capacity
draw volume (3.6) plus volume of additive (3.2) not including any accessories
3.12
primary colour
dominant colour of closure (3.3) component most representative of the additive (3.2) in the container (3.4)
Note 1 to entry: Dominant is the colour of the closure that covers the majority of the surface.
3.13
primary pack
smallest package of containers (3.4)
3.14
relative centrifugal force
RCF
force that is generated during the sample centrifugation process, which is specified by the manufacturer
for adequate separation
3.15
specimen
venous blood collected in a container (3.4)
3.16
tube
part of the container (3.4), without the closure (3.3), that contains the specimen (3.15)
3.17
visual inspection
inspection by an observer with normal or corrected-to-normal vision without magnification under a
uniform illuminance between 500 lx and 1 000 lx
4 Materials
4.1 The tube 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.
2 © ISO 2017 – All rights reserved

4.2 If a container is intended specifically for the determinatio
...