SIST EN ISO 6710:2017
(Main)Single-use containers for venous blood specimen collection (ISO 6710:2017)
Single-use containers for venous blood specimen collection (ISO 6710:2017)
This document specifies requirements and test methods for single-use receptacles, intended by their manufacturer, for the collection of venous blood specimens derived from the human body, for the purposes of in vitro diagnostic examination. This document also applies to receptacles containing media for blood culture.
This document does not specify requirements for capillary blood specimen receptacles or arterial blood specimen receptacles. This document does not specify requirements and test methods for single-use receptacles intended for the collection of specimens, other than blood.
Gefäße zur einmaligen Verwendung für die venöse Blutentnahme (ISO 6710:2017)
Diese Internationale Norm legt Anforderungen an und Prüfungen für evakuierte und nicht evakuierte Probengefäße (-behälter) zur einmaligen Verwendung für die venöse Blutentnahme fest.
Sie legt keine Anforderungen an Blutentnahmekanülen, Kanülenhalter, Blutkulturgefäße oder Entnahme-vorrichtungen für arterielles Blutgas, die für venöses Blut verwendet werden dürfen, fest.
In einigen Ländern sind das nationale Arzneibuch oder andere nationale Bestimmungen rechtlich bindend und haben Vorrang vor dieser Norm.
Récipients non réutilisables pour prélèvements de sang veineux (ISO 6710:2017)
L'ISO 6710 :2017 spécifie les exigences et les méthodes d'essai relatives aux récipients à usage unique pour prélèvements de sang veineux, sous vide ou non.
Il ne spécifie pas les exigences relatives aux aiguilles de prélèvement sanguin, aux supports d'aiguille, aux récipients pour hémoculture ou aux dispositifs de prélèvement de gaz du sang «artériel» pouvant aussi être utilisés pour le sang veineux.
Kontejnerji (epruvete s podtlakom) za zbiranje venske krvi ob enkratni uporabi (ISO 6710:2017)
Ta dokument določa zahteve in preskusne metode za vsebnike za enkratno uporabo, ki jih je proizvajalec predvidel za zbiranje venske krvi iz človeškega telesa za namene diagnostičnih preiskav in vitro. Ta dokument se uporablja tudi za vsebnike, ki vsebujejo gojišča za krvne kulture.
Ta dokument ne določa zahtev za vsebnike kapilarne ali arterijske krvi. Ta dokument ne določa zahtev in preskusnih metod za vsebnike za enkratno uporabo, ki so namenjeni zbiranju nekrvnih vzorcev.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 6710:2017
01-november-2017
1DGRPHãþD
SIST EN 14820:2005
Kontejnerji (epruvete s podtlakom) za zbiranje venske krvi ob enkratni uporabi
(ISO 6710:2017)
Single-use containers for venous blood specimen collection (ISO 6710:2017)
Gefäße zur einmaligen Verwendung für die venöse Blutentnahme (ISO 6710:2017)
Récipients non réutilisables pour prélèvements de sang veineux (ISO 6710:2017)
Ta slovenski standard je istoveten z: EN ISO 6710:2017
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 6710:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 6710:2017
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SIST EN ISO 6710:2017
EN ISO 6710
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2017
EUROPÄISCHE NORM
ICS 11.040.20 Supersedes EN 14820:2004
English Version
Single-use containers for human venous blood specimen
collection (ISO 6710:2017)
Récipients non réutilisables pour prélèvements de Gefäße zur einmaligen Verwendung für die venöse
sang veineux humain (ISO 6710:2017) Blutentnahme (ISO 6710:2017)
This European Standard was approved by CEN on 23 August 2017.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, 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: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 6710:2017 E
worldwide for CEN national Members.
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SIST EN ISO 6710:2017
EN ISO 6710:2017 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European standard and the essential
requirements of Directive 98/79/EC [OJ L 331] aimed to be covered . 5
2
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SIST EN ISO 6710:2017
EN ISO 6710:2017 (E)
European foreword
This document (EN ISO 6710:2017) 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 218, and conflicting national standards shall be
withdrawn at the latest by September 2020.
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 has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
This document supersedes EN 14820:2004, of which the following has been changed:
— Clause "Introduction" has been updated;
— Clause "Scope" has been updated and phrased clearer. Blood culture bottles have been excluded
from this standard, as it does not address the special needs for this kind of testing;
— Clause "Normative references" has been updated;
— Clause 'Terms and definitions" has been updated and extended;
— Clause "Materials" has been updated;
— Clause "Nominal liquid capacity" has been shortened and renamed to "Draw volume";
— Clause "Graduation and fill lines" has been deleted;
— Clause "Design" has been updated;
— Clause "Construction" has been updated and shortened;
— Clause "Sterility and special microbiological states" has been technically revised;
— Clause "Additives" has been updated and shortened;
— Clause "Information supplied by the manufacturer" has been updated to meet current general
requirements (except local requirements), and renamed to "Marking and labelling";
— Clause "Receptacle and additive identification" has been updated and renamed to "Container
identification". Table "Letter codes identifying the more common additives for blood specimen
receptacles" within this clause has been renamed to "Letter codes for identifying additives and
accessories" and extended by additional entries for additives;
3
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SIST EN ISO 6710:2017
EN ISO 6710:2017 (E)
— Tests in Normative Annexes A to D have been updated in alignment with the requirements in the
body part of the standard. Annex A "Test for nominal liquid capacity and graduation marks, for non-
evacuated blood specimen receptacles" was renamed to "Draw volume test for non-evacuated
containers". Annex B "Test for draw volume for evacuated receptacles" was renamed to "Draw
volume test for evacuated containers" and a figure was added for better explanation. Annex C "Test
for leakage from the closure of a receptacle" was renamed to "Test for leakage of container". Annex
D "Test for the robustness of a receptacle that is intended for centrifugations" was renamed to "test
for robustness of the container";
— Normative Annex E "Concentrations of additives and volume of liquid additives" has been added;
— Informative Annex F "Recommended colour codes for identifying additives and accessories" has
been added;
— The Bibliography has been updated.
The following referenced documents are indispensable for the application of this document. For
undated references, the latest edition of the referenced document (including any amendments) applies.
For dated references, only the edition cited applies. However, for any use of this standard ‘within the
meaning of Annex ZA’, the user should always check that any referenced document has not been
superseded and that its relevant contents can still be considered the generally acknowledged state-of-
art.
When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version
of the ISO or IEC standard, as listed below.
NOTE The way in which these referenced documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Table — Correlations between normative references and dated EN and ISO standards
Normative references as listed in Equivalent dated standard
Clause 2 of the ISO standard
EN ISO or IEC
ISO 15223-1 EN ISO 15223-1:2016 ISO 15223-1:2016
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, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 6710:2017 has been approved by CEN as EN ISO 6710:2017 without any modification.
4
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SIST EN ISO 6710:2017
EN ISO 6710:2017 (E)
Annex ZA
(informative)
Relationship between this European standard and the essential
requirements of Directive 98/79/EC [OJ L 331] aimed to be covered
This European standard has been prepared under a Commission’s standardisation request, M/252,
concerning the development of European standards relating to in vitro diagnostic medical devices, to
provide one voluntary means of conforming to essential requirements of Directive 98/79/EC of the
European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices [OJ L
331].
Once this standard is cited in the Official Journal of the European Union under that Directive,
compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of
the scope of this standard, a presumption of conformity with the corresponding essential requirements
of that Directive, and associated EFTA regulations.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Directive 98/79/EC. This means that risks have to be
reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’ or ‘removed’, according to
the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential
Requirements Part A: 1, 2 and 5; Part B: 1.2, 2, 3, 5, 6 and 7 of the Directive.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZA.1 — Correspondence between this European standard and Annex I of Directive
98/79/EC [OJ L 331]
Essential Requirements of Clause(s) / subclause(s) of Remarks / Notes
Directive 98/79/EC this EN
B.1.2 4.2, 5, 6.1, 6.2, 7.1, Annex C Covered for leakage from the
container during use. Not
covered for storage and
transport.
B.2.1 4.3, 6.1, 6.2, 6.3, 7.1, Annex C Covered for leakage from the
container during use and easy
handling.
B.2.3 8.2 Covered for ensuring the
container is sterile or in a
special microbiological state.
Does not cover other aspects
of this ER including labelling,
storage and transport.
B.2.4 8.2
5
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SIST EN ISO 6710:2017
EN ISO 6710:2017 (E)
Essential Requirements of Clause(s) / subclause(s) of Remarks / Notes
Directive 98/79/EC this EN
B.3.1 5 Covered for draw volume.
B.3.3 5, 7.1, 7.2 Covered for physical
characteristics (sharp edges
etc.) and for use with
centrifuges.
B.4.1 Annex A, Annex B Covered for accuracy of
measurement within
appropriate accuracy limits in
the first sentence of this ER.
B.8.4 (b) 10.3 d)
B.8.4 (c) 10.3 d) third indent Covered for sterility.
B.8.4 (d) 10.3 b) Only covered if the batch code
is preceded by the word ‘LOT’.
B.8.4 (e) 10.3 c)
B.8.4 (h) 10.3 d) fifth intent Covered for storage.
WARNING 1: Presumption of conformity stays valid only as long as a reference to this European
standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2: Other Union legislation may be applicable to the product(s) falling within the scope of this
standard.
6
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SIST EN 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 6710:2017(E)
©
ISO 2017
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SIST EN ISO 6710:2017
ISO 6710:2017(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, 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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Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved
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SIST EN ISO 6710:2017
ISO 6710:2017(E)
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
© ISO 2017 – All rights reserved iii
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SIST EN ISO 6710:2017
ISO 6710:2017(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 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
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SIST EN ISO 6710:2017
ISO 6710:2017(E)
— references in Clause 2 and Bibliography have been updated.
© ISO 2017 – All rights reserved v
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SIST EN ISO 6710:2017
ISO 6710:2017(E)
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
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SIST EN ISO 6710:2017
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)
© ISO 2017 – All rights reserved 1
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SIST EN ISO 6710:2017
ISO 6710:2017(E)
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
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SIST EN ISO 6710:2017
ISO 6710:2017(E)
4.2 If a container is intended specifically for the determination of a certain element/substance, 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 10.4).
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 (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
and consult the manufacturer.
4.3 The container shall be free from foreign matter when subjected to visual inspection.
5 Draw volume
When tested in accordance with the methods specified in Annexes A and B, the volume of water should
be within ±10 % of the draw volume. If ±10 % of draw volume is not met throughout the shelf life, the
manufacturer shall ensure that correct results shall be obtained.
6 Design
6.1 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.
6.2 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.
6.3 Consideration in the design shall be given to ensure compatibility with transportation systems,
processes, pre-analytical and analytical automation.
7 Construction
7.1 The container holding the specimen shall not break, crack or leak, when centrifuged at an RCF of
3 000 g or the value specified by the manufacturer for the intended use, when tested in accordance with
the method specified in Annex D.
2
NOTE g = 9,806 65 m/s .
7.2 When subjected to visual inspection, the container shall not have a sharp edge, projection or
surface roughness capable of accidentally cutting, puncturing or abrading the skin of the user.
8 Sterility and special microbiological states
8.1 For evacuated containers, the interior shall be sterile if unused. The container interior and any
...
SLOVENSKI STANDARD
oSIST prEN ISO 6710:2016
01-december-2016
Kontejnerji (epruvete s podtlakom) za zbiranje venske krvi ob enkratni uporabi
(ISO/DIS 6710:2016)
Single-use containers for venous blood specimen collection (ISO/DIS 6710:2016)
Gefäße zur einmaligen Verwendung für die venöse Blutentnahme (ISO/DIS 6710:2016)
Récipients non réutilisables pour prélèvements de sang veineux (ISO/DIS 6710:2016)
Ta slovenski standard je istoveten z: prEN ISO 6710
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
oSIST prEN ISO 6710:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 6710:2016
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oSIST prEN ISO 6710:2016
DRAFT INTERNATIONAL STANDARD
ISO/DIS 6710
ISO/TC 76 Secretariat: DIN
Voting begins on: Voting terminates on:
2016-10-19 2017-01-10
Single-use containers for venous blood specimen collection
Récipients non réutilisables pour prélèvements de sang veineux
ICS: 11.040.20
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 6710:2016(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 2016
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oSIST prEN ISO 6710:2016
ISO/DIS 6710:2016(E)
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oSIST prEN ISO 6710:2016
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Contents Page
Foreword .iv
Introduction .v
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 . 7
Annex B (normative) Draw volume test for evacuated containers . 8
Annex C (normative) Test for leakage of container.10
Annex D (normative) Test for robustness of the container .12
Annex E (normative) Concentrations of additives and volume of liquid additive .13
Annex F (informative) Recommended colour codes for identifying additives and accessories .15
Annex ZA (informative) Relationship between this European standard and the essential
requirements of Directive 98/79/EC [OJ L 331] aimed to be covered .16
Bibliography .18
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oSIST prEN ISO 6710:2016
ISO/DIS 6710:2016(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 on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/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), of which the following has
been changed:
— Clause ‘Terms and definitions” has been updated and extended;
— Clause “Capacity” has been shortened and renamed to “Draw volume”;
— Clause “Design” has been updated;
— Clause “Sterility” has been technically revised and renamed to “Sterility and special microbiological
states”;
— Clause “Additives” has been extended;
— Clause “Marking and labelling” has been slightly updated to meet current general requirements
(except local requirements);
— Table “Letter codes and recommended colour codes for identifying additives” in Clause “Container
identification” has been extended by additional entries for additives. The Table has been reduced
to the specified letter codes, while the information on recommended colour codes for identifying
additives has been moved to a new informative Annex F (for clarification see Introduction);
— Tests in Normative Annexes A to D have been updated in alignment with the requirements in the
body part of the standard;
— Annex E has been completely revised;
— Normative references and Bibliography have been updated.
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Introduction
ISO 6710 was first published in 1995. With the first revision starting in 2000 the Vienna Agreement
was applied to develop an updated edition of the standard in parallel between ISO and CEN.
However, in 2002 the parallel ballot on ISO/DIS 6710-2 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. Though, 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 security 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 with the final goal again to development an International Standard in parallel with a
harmonized European Standard.
During the development it was recognized that 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 an informative 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 the standard 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 in the
years after the publication of this International Standard, with the next revision there is the intention
to possibly move the content of the informative Annex F ‘Recommended colour codes for identifying
additives’ to the normative part of the standard.
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oSIST prEN ISO 6710:2016
DRAFT INTERNATIONAL STANDARD ISO/DIS 6710:2016(E)
Single-use containers for venous blood specimen collection
1 Scope
This International Standard 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 may be used for venous blood.
In some countries, the national pharmacopoeia or other national regulations are legally binding and
take precedence over this standard.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. 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
ISO/IEC/DIS 80369-7:2013, Small bore connectors for liquids and gases in healthcare applications —
Part 7: Connectors with 6% (Luer) taper for intravascular or hypodermic applications
3 Terms and definitions
For the purposes of this document, the following definitions apply.
3.1
accessory
component inside the container which is intended by the manufacturer to assist in the collection, or
mixing, or separation of the specimen
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
any substance (other than inside surface treatments designed to be irremovable) that is placed in the
container in order to facilitate the creation of the desired sample
3.3
closure
component by which the container is sealed, which may consist of several parts
3.4
container
vessel, whether evacuated or not, intended to contain a specimen, together with any container accessory
and additive, with closure in place
3.5
container interior
inside surface of the container or closure and the surface of any accessory exposed to the specimen
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3.6
draw volume
volume of whole blood that will be collected in the container
3.7
evacuated container
container 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 indication
line marked on a tube or its label to indicate the correct filling
3.10
free space
space above the drawn sample
3.11
nominal liquid capacity
draw volume plus volume of additive not including any accessories
3.12
primary colour
dominant colour of closure component most representative of the additive in the container
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
3.14
RCF
relative centrifugal force, the 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
3.16
tube
part of the container, without the closure, that contains the specimen
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 1000 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 ultra violet light or visible light would degrade the contents.
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4.2 If a container is intended specifically for the determination of a certain element/substance, the
maximum level of the element/substance in the container interior and the analytical method employed
shall be stated by the manufacturer in accompanying literature or on the label or packaging (see also 10.4).
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 (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
and consult the manufacturer.
4.3 The container shall be free from foreign matter when subjected to visual inspection.
5 Draw volume
When tested in accordance with the methods specified in Annexes A and B, the volume of water should
be within ± 10 % of the draw volume. If the ± 10 % of draw volume is not met throughout the shelf life,
the manufacturer has to assure that correct results shall be obtained.
6 Design
6.1 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.
6.2 Where a closure is intended to be removed to gain access to the contents of the container, it shall
be designed so that it can be removed by gripping with the fingers and/or by mechanical means without
that part of the closure which may be contaminated by contact with the specimen being touched by the
fingers.
6.3 Consideration in the design shall be given to ensure compatibility with transportation systems,
processes, pre-analytical and analytical automation.
7 Construction
7.1 The container holding the specimen, when centrifuged, shall withstand an acceleration at a RCF
minimum of 3 000 g , or the value specified by the manufacturer for the intended use, when tested in
accordance with the method specified in Annex D.
2
NOTE g = 9,806 65 m/s
n
7.2 When subjected to visual inspection, the container shall not have a sharp edge, projection or
surface roughness capable of accidentally cutting, puncturing or abrading the skin of the user.
8 Sterility and special microbiological states
8.1 The interior of the evacuated container shall be sterile if unused.
8.2 If a manufacturer claims that the interior of the unopened and unused container, or the whole
container, is sterile, or has a special microbiological state, the container interior and any accessory or
additive shall have been subjected to a validated process designed to achieve that claim.
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8.3 Containers with microbe-supporting additives such as trisodium citrate or citrate phosphate
dextrose adenine solution shall have been subjected to a validated process to eliminate microbial
contamination from the additive and the container interior.
9 Additives
9.1 The stated nominal amount of additive shall be within the range specified in Annex E.
9.2 For containers with an additive, provision shall be made for mixing by using the free space bubble
to facilitate agitation, or by some other physical means.
NOTE This document does not specify a validation procedure for adequate mixing of the blood specimen.
9.3 The free space in containers for coagulation testing should not impact the analytical results. The
manufacturer should assess the risk associated with the free space in the correctly filled containers.
10 Marking and labelling
10.1 Non-transparent labels shall not completely encircle the tubes.
10.2 The marking and labelling on the container shall remain adherent over its shelf life, under storing
conditions as specified by the manufacturer.
10.3 Each primary pack shall be marked on the outside at least with the following information:
a) the manufacturer’s or supplier’s name or trademark;
b) the batch number;
c) the expiry date which should be expressed in the format YYYY-MM or YYYY-MM-DD;
d) a description of the contents, which shall include
— the nominal liquid capacity or draw volume;
— the letter code (see Clause 11) and/or product name and/or a description of the contents;
— the word „STERILE” or the appropriate graphical symbol according to ISO 15223-1 if the manufacturer
claims that the unopened container interior and any contents of the container are sterile;
— the words „Single-use only” or the appropriate graphical symbol according to ISO 15223-1;
— storage requirements;
— labelling requirements from the local legislation.
10.4 If a container is provided specifically for the determination of a certain substance, the maximum
level of contamination with that substance shall be stated on the label, the primary pack or in the
accompanying information.
10.5 If a container has a liquid additive its volume shall be stated on the label, the primary pack or in the
accompanying information.
10.6 Containers shall have the following information marked directly onto the tube or on the label:
a) the manufacturer’s or supplier’s name or trademark;
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b) the batch number;
c) the letter code (see Clause 11) and/or product name and/or a description of the contents;
d) the expiry date which should be expressed in the format YYYY-MM or YYYY-MM-DD;
e) the nominal liquid capacity or draw volume, specified where appropriate on the container;
f) the words „Single-use only” or the appropriate graphical symbol according to ISO 15223-1;
g) a fill indication; if that is not possible, information on how to fill the container correctly shall be
provided on the primary pack or in the accompanying literature ;
h) the word “STERILE” or the appropriate graphical symbol according to ISO 15223-1 if the
manufacturer claims that the unopened and unused container interior and any contents of the
container are sterile.
10.7 If the container is intended to be stored, or used, under specific conditions, this shall be clearly
stated on the container, or on the label and/or on the accompanying literature in the primary pack.
11 Container identification
Containers shall be identified by means of the letter code and/or product name and/or a description
of the contents for the additives and accessories given in Table 1. Where there are additives and
accessories other than those in Table 1, containers shall be identified by means of the description of the
additive and/or product name.
Recommended colour codes for identifying additives and accessories are provided in the informative
Annex F (for more details see also Introduction).
Table 1 — Letter codes for identifying additives and accessories
Additive/Accessory Letter code
a
EDTA dipotassium salt K2E
tripotassium salt K3E
b
Trisodium citrate 9:1 9NC
b
Trisodium citrate 4:1 4NC
Fluoride oxalate FX
Fluoride EDTA FE
Fluoride heparin FH
Fluoride, citric acid FC
Lithium heparin LH
Lithium heparin and gel LH
Sodium heparin NH
a
EDTA is the abbreviation for ethylenediaminetetraacetic acid which by
established custom is used in preference to the correct systematic name, i.e.
(ethylenedinitrilo)tetraacetic acid.
b
Denotes the ratio between the intended volumes of blood and liquid
anticoagulant (e.g., 9 volumes of blood to 1 volume of citrate solution).
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Table 1 (continued)
Additive/Accessory Letter code
Citrate phosphate dextrose adenine CPDA
Acid citrate dextrose ACD
Clot activator CAT
Clot activator with gel CAT
None Z
a
EDTA is the abbreviation for ethylenediaminetetraacetic acid which by
established custom is used in preference to the correct systematic name, i.e.
(ethylenedinitrilo)tetraacetic acid.
b
Denotes the ratio between the intended volumes of blood and liquid
anticoagulant (e.g., 9 volumes of blood to 1 volume of citrate solution).
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Annex A
(normative)
Draw volume test for non-evacuated containers
A.1 Reagents and apparatus
A.1.1 Deionized water.
A.1.2 Calibrated electronic balance accurate to a minimum of 3 decimal places 0,001 g.
A.1.3 Device to hold the test container vertically in the correct orientation on the balance.
A.1.4 Vessel to enable dispensing of water into the test container.
A.2 Test conditions
A.2.1 The tests shall be carried out in ambient conditions of 101 kPa and 20 °C; make corrections if
other conditions are used.
A.2.2 The containers to be tested shall be unused.
A.3 Test procedure
A.3.1 Fill the vessel with the deionized water.
A.3.2 Place the container on to the balance and tare (zero).
A.3.3 Position the test container with closure removed and fill with water until the meniscus is level
with the fill line.
A.3.4 Place the test container on the previously tared balance and read the weight in gram.
A.3.5 Calculate the fill volume 1 000 g = 1 000 ml.
A.4 Test criteria
The container shall pass the draw volume test if the volume of water delivered is within ± 10 % of the
draw volume capacity.
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Annex B
(normative)
Draw volume test for evacuated containers
B.1 Reagents and apparatus
B.1.1 Deionized water.
B.1.2 Calibrated electronic balance accurate to a minimum of 3 decimal places 0,001 g.
B.1.3 Device to hold the test container vertically in the correct orientation on the balance.
B.1.4 Water vessel with spout at its base to enable connection to rubber tubing.
B.1.5 Rubber tubing fitted with a spring clip at one end and attached to the water vessel at the other
end (see Figure B.1).
B.1.6 Blood collection needles as recommended by the manufacturer of the test container.
B.1.7 Holder as recommended by the manufacturer of the test container.
B.2 Test conditions
B.2.1 The tests shall be carried out in ambient conditions of 101 kPa and 20 °C; make corrections if
other conditions are used.
B.2.2 The container to be tested shall be unused.
B.3 Test procedure
B.3.1 Assemble the vessel to the tubing, tighten the spring clip on end of the rubber tubing.
B.3.2 Fill the vessel with the water.
B.3.3 Bleed the water through the spring clip to fill the silicone rubber tubing.
B.3.4 Assemble the product, if not supplied ready-assembled, and fit the blood collection needle into
the holder in accordance with the manufacturer’s instructions.
B.3.5 Place the test container on to the balance and tare (zero).
B.3.6 Insert the intra-venous needle of the blood collection needle/holder assembly through the wall
of the tubing until the needle is well inside the lumen of the silicone tubing.
B.3.7 Connect the test container to the needle/holder assembly in accordance with the manufacturer’s
instructions.
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B.3.8 Allow the test container to fill for at least 1 min or fill as specified by the manufacturer.
B.3.9 Place the test container on the previously tared balance and read the weight in gram.
B.3.10 Calculate the fill volume 1 000 g = 1 000 ml.
B.4 Test criteria
The container shall pass the draw volume test if the volume of water delivered is within ± 10 % of the
draw volume capacity.
Figure B.1 — Water vessel assembly for draw volume test for evacuated containers
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Annex C
(normative)
Test for leakage of container
C.1 Reagents
1)
C.1.1 Solution prepared by dissolving 2,5 g of sodium fluorescein [uranine; CAS number 518-47-81] )
in 100 ml of 0,15 mol/l sodium chloride [NaCl; CAS number 7647-14-5] solution containing 60 g/l
Dextran 70 [CAS number 9004-54-0] or equivalent.
C.1.2 Deionized water that shows no sign of fluorescence when viewed under ultraviolet light (C.2.2)
in a darkened room by an observer with normal or corrected-to-normal vision without magnification.
C.2 Apparatus
C.2.1 Reservoir (for the sodium fluorescein reagent) attached to a convenient length of plastic tubing
(a length of 1 m has been found suitable). When testing an evacuated container, the tubing shall be fitted
with a blood collection needle as recommended by the manufacturer. When testing other containers, the
tubing shall be fitted with a hollow tip of rigid material that terminates in a conical male fitting with a
6 % Luer taper which complies with ISO/IEC/DIS 80369-7.
C.2.2 Long-wave ultraviolet light (UV) source
C.2.3 Roller-type mixer or other mixer recomme
...
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