EN ISO 6710:2017

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

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
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;
— 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.

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
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.
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
ISO 6710:2017(E)
© ISO 2017, Published in Switzerland
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ii © ISO 2017 – All rights reserved

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 .
...