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

Status
Published
Public Enquiry End Date
19-Dec-2016
Publication Date
17-Oct-2017
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
05-Oct-2017
Due Date
10-Dec-2017
Completion Date
18-Oct-2017

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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.

---------------------- Page: 1 ----------------------
SIST EN ISO 6710:2017
---------------------- Page: 2 ----------------------
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.
---------------------- Page: 3 ----------------------
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

---------------------- Page: 4 ----------------------
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;
---------------------- Page: 5 ----------------------
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.

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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
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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.
---------------------- Page: 8 ----------------------
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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
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.
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

...

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