ISO/DIS 6710.2

DRAFT INTERNATIONAL STANDARD ISO/DIS 6710.2
ISO/TC 76 Secretariat: DIN
Voting begins on Voting terminates on
2002-08-01 2002-10-01

INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION

The CEN Secretary-General has advised the ISO Secretary-General that this ISO/DIS covers a

subject of interest to European standardization. In accordance with the ISO-lead mode of

collaboration as defined in the Vienna Agreement, consultation on this ISO/DIS has the same

effect for CEN members as would a CEN enquiry on a draft European Standard. Should this draft

be accepted, a final draft, established on the basis of comments received, will be submitted to a

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In accordance with the provisions of Council Resolution 15/1993 this document is circulated

Conformément aux dispositions de la Résolution du Conseil 15/1993, ce document est

THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE REFERRED TO

IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT

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under the applicable laws of the user's country, neither this ISO draft nor any extract from it may be reproduced,

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Requests for permission to reproduce should be addressed to either ISO at the address below or ISO's member

The CEN Secretary-General has advised the ISO Secretary-General that this ISO/DIS covers a subject of interest

to European standardization. In accordance with subclause 5.1 of the Vienna Agreement, consultation on this

ISO/DIS has the same effect for CEN members as would a CEN enquiry on a draft European Standard. Should this

draft be accepted, a final draft, established on the basis of comments received, will be submitted to a parallel two-

Foreword..................................................................................................................................................................... v

Introduction ............................................................................................................................................................... vi

1 Scope.............................................................................................................................................................. 1

2 Normative references ................................................................................................................................... 1

3 Terms and definitions................................................................................................................................... 1

4 Materials......................................................................................................................................................... 3

5 Nominal liquid capacity................................................................................................................................ 4

6 Graduation and fill lines ............................................................................................................................... 4

6.1 Graduation line.............................................................................................................................................. 4

6.2 Maximum fill line ........................................................................................................................................... 4

6.3 Minimum fill line ............................................................................................................................................ 4

7 Design ............................................................................................................................................................ 4

8 Construction.................................................................................................................................................. 5

9 Sterility and special microbiological states ............................................................................................... 5

10 Additives ........................................................................................................................................................ 5

11 Information supplied by the manufacturer................................................................................................. 6

12 Receptacle and additive identification........................................................................................................ 7

Annex A (normative) Tests for nominal liquid capacity and graduation marks, for non-evacuated blood

specimen receptacles................................................................................................................................... 8

A.1 Reagents and apparatus .............................................................................................................................. 8

A.2 Test Conditions ............................................................................................................................................. 8

A.3 Test Procedure .............................................................................................................................................. 8

Annex B (normative) Tests for draw volume for evacuated receptacles by weight and by volume ................. 9

B.1 Reagents and apparatus .............................................................................................................................. 9

B.2 Test Conditions ............................................................................................................................................. 9

B.3 Test procedures ............................................................................................................................................ 9

B.3.1 Gravimetric method ...................................................................................................................................... 9

B.3.2 Volumetric method........................................................................................................................................ 9

Annex C (normative) Test for leakage from the closure of a receptacle ............................................................ 11

C.1 Reagents and apparatus ............................................................................................................................ 11

C.2 Test procedure for non-evacuated container........................................................................................... 11

C.3 Test procedure for evacuated receptacles............................................................................................... 11

Annex D (normative) Test for the robustness of a receptacle that is intended for centrifugation .................. 13

D.1 Reagents and apparatus ............................................................................................................................ 13

D.2 Test conditions............................................................................................................................................ 13

D.3 Test procedure ............................................................................................................................................ 13

Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other

provisions of EC Directives. ...................................................................................................................... 14

Bibliography ............................................................................................................................................................. 16

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

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.

The main task of technical committees is to prepare International Standards. Draft International Standards adopted

by the technical committees are circulated to the member bodies for voting. Publication as an International

Attention is drawn to the possibility that some of the elements of this International Standard may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights.

ISO 6710 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection for medical and

This second edition cancels and replaces the first edition of 1995-08 which has been technically revised.

This International Standard provides requirements relevant to specimen containers (receptacles) for venous blood.

Revision of ISO 6710:1995 was proposed by a number of countries, mainly in Europe, due to technical changes

made in the manufacture of these containers (receptacles). For their perceived safety of patients, a number of

countries strongly require colour coding of containers (receptacles) for the identification of additives. Two well

established colour codes are in common use without any known reports of incidents affecting patient safety arising

from differences in colour code. Furthermore, it is suggested that bespoke colour coding of these products is an

increasing trend. Any changes by manufacturers increase the cost of production and as a consequence the price of

receptacles (containers) to users. It has not therefore been possible to make any agreed international

recommendations on colour codes of receptacles (containers) and so this International Standard has been

prepared without a recommended colour codes as the only possible means of obtaining consensus by Standards

This standard specifies requirements and test methods for single-use receptacles, intended by their manufacturer,

for the collection of venous blood specimens from the human body, for the purposes of in vitro diagnostic

examination. This standard also applies to receptacles containing media for blood culture.

This standard does not specify requirements for capillary blood specimen receptacles or arterial blood specimen

receptacles. This standard does not specify requirements and test methods for single-use receptacles intended for

The following normative documents contain provisions which, through reference in this text, constitute provisions of

this International Standard. For dated references, subsequent amendments to, or revisions of, any of these

publications do not apply. However, parties to agreements based on this International Standard are encouraged to

investigate the possibility of applying the most recent editions of the normative documents indicated below. For

undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC

ISO 594-1, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment —

For the purposes of this International Standard, the following terms and definitions apply.

substance, other than surface treatments designed to be irremovable, that is placed inside the receptacle to

facilitate the preservation of the specimen, or is intended to react with the specimen, in order to allow the intended

twisting force, specified by the manufacturer, that is required to tighten a screw threaded closure sufficiently, by

part of the receptacle without the closure, and without any accessory, that contains the specimen

NOTE Depending on the intended application, the part of the receptacle, without the closure, that contains a blood

receptacle intended for specimen collection by means of evacuation, either already induced by the manufacturer

(i.e. pre-evacuated receptacle), or induced by the user immediately before a liquid specimen is taken

mark on a container, or its label, to indicate the nominal liquid capacity of a container, or filling capacity of a

volume of liquid specimen needed to achieve the required additive to specimen ratio

extra capacity, or headspace, which is provided to allow adequate mixing of the contents of a receptacle

method of determining the volume of a liquid by weighing and correcting for the mass density of the liquid

NOTE For the purposes of this standard 1,000 ml of water is considered to have a mass equal to 1,000 g.

method of determining the volume of a liquid by weighing and correcting for the mass density of the liquid

NOTE For the purposes of this standard 1,000 ml of water is considered to have a mass equal to 1,000 g

mark on a container or its label, to indicate the maximum volume of specimen required to ensure that the in vitro

mark on a container, or its label, to indicate the minimum volume of specimen required to ensure that the in vitro

device that is intended to be attached to an evacuated receptacle to enable venous puncture and subsequent

volume of specimen with which the receptacle is intended to be filled plus the volume of any additive

vessel, whether evacuated or not, intended to contain a specimen, together with any receptacle accessory and

component inside the receptacle which is intended by the manufacturer to assist in the collection, or mixing, or

NOTE Examples of receptacle accessories are small plastic inert balls (or a separate gel), designed to agitate the blood

specimen during mixing, or inert plastic beads used to form a layer between the serum or plasma and the cells after

inside surface of the receptacle or closure and the surface of any receptacle accessory exposed to the specimen

biological material which is obtained in order to detect properties or to measure one or more quantities

inspection by an observer with normal, or corrected-to-normal, vision without magnification, under a uniform

4.1 If a receptacle is intended to contain a specimen for a specific analysis, where the material of the closure, or

container, or the interior coating, or the additive, or accessory, if present, may affect the final results of the test,

then the maximum level of the contamination with that substance, and the analytical method employed, shall be

stated by the manufacturer on the label, packaging or documentation (see also 11.4). Validation of the suitability of

material with regard to a receptacle's specifically intended use is the responsibility of the manufacturer.

NOTE 1 This standard does not specify a validation procedure for material suitability.

NOTE 2 For certain infrequently performed analyses, limits of interference may not have been determined and the user is

NOTE 3 A container should be manufactured from a material which allows a clear view of the contents when subjected to

visual inspection by an observer with normal, or corrected to normal, vision without magnification, under uniform illumination

between 300 lx and 750 lx unless exposure to UV or visible light would degrade the contents.

NOTE 4 If the container is not made of material that allows a clear view of the contents, the closure may be removed, to

4.2 When subjected to visual inspection the material of the receptacle shall be free from foreign matter.

4.3 Receptacles containing a microbe-supporting additive shall have been subjected to a validated process to

eliminate microbial contamination from the additive and the receptacle interior. Validation of the process is the

NOTE For validation procedures and routine control of procedures for sterilisation methods see ISO 11134, ISO 11135 and

5.1 When tested in accordance with the methods specified in either annex A or B, the volume of water added

from, or drawn from, the burette, plus the volume of any additive present, shall be between 90 % and 110 % of the

5.2 For receptacles with an additive, provision shall be made for mixing by using the free space bubble to

5.3 Where free space is intended to facilitate mixing there shall be sufficient free space to allow mixing by

5.4 The manufacturer shall validate that adequate mixing of the blood specimen, with any additive present, can

NOTE This standard does not specify a validation procedure for adequate mixing of the blood specimen.

When non-evacuated receptacles that have graduation marks are tested in accordance with methods specified in

annex A, the volume of water shall be between 90 % and 110 % of the indicated volume.

NOTE This test is not suitable for non-evacuated receptacles that contain a liquid additive.

Evacuated receptacles that have a maximum fill line on the container, or container label, shall fill such that the

meniscus of the liquid reaches, but does not exceed, the position of the line when tested in accordance with the

Evacuated receptacles that have a minimum fill line on the container, or container label, shall fill such that the

meniscus of the liquid reaches, or exceeds, the position of the line when tested in accordance with the method

7.1 The closure shall not become loose when tested for leakage in accordance with the method specified in