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YY 0314-2007: [Including YY 0314-2013XG] Single-use containers for venous blood specimen collection
YY 0314-2007
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
Replacing YY 0314-1999
Single-use containers for human
venous blood specimen collection
(EN 14820.2004, MOD)
ISSUED ON. JULY 02, 2007
IMPLEMENTED ON. AUGUST 01, 2008
Issued by. China Food and Drug Administration
Table of Contents
Foreword . 4
Introduction .. 5
1 Scope .. 6
2 Normative references .. 6
3 Terms and definitions .. 6
4 Materials .. 10
5 Nominal liquid capacity .. 11
6 Graduation marks and fill lines .. 11
7 Design .. 12
8 Construction .. 12
9 Sterility and special microbiological states .. 13
10 Additives .. 13
11 Information supplied by the manufacturer . 14
12 Receptacle and additive identification . 15
Annex A (Normative) Test for nominal liquid capacity and graduation marks, for
non-evacuated blood specimen receptacles .. 17
Annex B (Normative) Tests for draw volume for evacuated receptacles .. 19
Annex C (Normative) Test for leakage from the closure of a receptacle .. 21
Annex D (Normative) Test for the robustness of a receptacle that is intended for
centrifugations.. 23
Annex NA (Informative) Recommended ambient atmospheric calibration
method .. 24
Annex NB (Informative) Draw volume test method for pre-evacuated
receptacles intended for use in high altitude areas . 25
Annex NC (Informative) Concentration of additives) . 28
Annex ND (Informative) Technical differences between this Standard and EN
14820-2004 and their causes . 30
Bibliography .. 32
Foreword
This Standard modifies-adopts EN 14820.2004 “Single-use containers for
human venous blood specimen collection”. See Annex ND for technical
modifications and their causes.
This Standard replaces YY 0314-1999 “Single-use containers for human
venous blood specimen collection”.
Compared with YY 0314-1999, changes of technical content mainly include.
- ADD “Graduation and fill lines” (Clause 6); CANCEL the quantitative
requirements for free space;
- ADD the content of special microbiological states;
- ADJUST the content of Annex E “Concentration of additives and volume of
liquid additives” of the original standard to an informative annex (Annex NC);
- ADD the informative Annex NA, which recommends the environmental
atmospheric calibration method;
- ADD the informative Annex NB, which recommends the draw volume test
method for pre-evacuated receptacles intended for use in high altitude
areas.
Annex A, Annex B, Annex C and Annex D of this Standard are normative
annexes. Annex NA, Annex NB, Annex NC and Annex ND of this Standard are
informative annexes.
This Standard was proposed by and shall be under the jurisdiction of National
Technical Committee on Medical Infusion Devices of Standardization
Administration of China.
Main drafting organizations of this Standard. Shandong Quality Inspection
Center for Medical Devices, BD Medical Devices Co., Ltd.
Main drafters of this Standard. Wu Ping, Song Jinzi, Jiang Yundan, Sun
Guangyu.
Single-use containers for human
venous blood specimen collection
1 Scope
This Standard 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 (referred to as “receptacle”). 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 collection of specimens, other than blood.
2 Normative references
The following documents contain the provisions which, through reference in this
Standard, become the provisions of this Standard. For dated references, their
subsequent amendments (excluding corrigendum) or revisions do not apply to
this Standard. However, the parties who enter into agreement based on this
Standard are encouraged to investigate whether the latest versions of these
documents are applicable. For undated reference documents, the latest
versions apply to this Standard.
GB/T 1963.1 Conical fittings with a 6% (Luer) taper for syringes, needles and
certain other medical equipment - Part 1. General requirements (GB/T
1962.1-2001, idt ISO 594-1.1986)
GB/T 6682-1992 Water for analytical laboratory use - Specification and test
methods (neq ISO 3696.1987)
3 Terms and definitions
For the purposes of this Standard, the following terms and definitions apply.
3.1
additive
NOTE. Examples of receptacle accessories are small plastic inert balls or a separate
gel found in a serum or plasma receptacle, designed to separate the serum or plasma
from the cells after centrifugation.
3.21
receptacle interior
Inside surface of the receptacle or closure and the surface of any receptacle
accessory exposed to the specimen.
3.22
specimen
Biological material (e.g. venous blood) which is obtained in order to detect
properties or to measure one or more properties.
3.23
visual inspection
Inspection by an observer with normal, or corrected-to-normal, vision without
magnification, under a uniform illumination in the range from 300 lx to 750 lx.
4 Materials
4.1 If a receptacle is intended to contain a specimen for a specific examination,
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 examination,
then the maximum level of the contamination with that substance, and the
analytical method employed, shall be stated by the manufacturer in
accompanying literature, or on the label, or packaging (see also 11.3).
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 examinations, limits of interference may
not have been determined and the user is recommended to consult the manufacturer.
NOTE 3. A container should be manufactured from a material which allows a clear view
of its contents when subjected to visual inspection (see 3.22) (unless exposure to ultra-
violet light, 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 facilitate the examination of the contents.
additive is suitable for its purpose.
10.4 The manufacturer shall ensure that the intended blood/additive ratio is
obtainable throughout the shelf- life of the product.
11 Information supplied by the manufacturer
11.1 Each receptacle shall be accompanied by the information needed to use
it properly, taking account of the training and knowledge of the potential user,
and to identify the manufacturer. This information shall be set out on the
receptacle itself, where space permits, and on any accompanying literature and
(or) on the primary pack.
NOTE. It is suggested that manufacturers may make use of electronic means, for
example the Internet, as an additional means of communicating practical and
functional information, concerning their product, to the end user.
11.2 As far as practical and appropriate the information needed to use the
receptacle safely and properly shall be set out on the receptacle itself and/or,
where appropriate, on the primary pack. If individual full labelling of each
receptacle is not practicable the information shall be set out on the packaging
and/or on the instructions for use supplied with one or more receptacles. Where
appropriate this information shall take the form of published symbols and color
codes. In areas/countries where no such published symbols or color codes
exist, the meaning of the symbol and color code used shall be described in the
documentation supplied with the receptacle.
11.3 If a receptacle is supplied specifically for the determination, or detection,
of a certain substance, the maximum level of contamination with the substance
shall be stated directly on the receptacle, or the label, if possible, and/or on any
accompanying literature and/or on the primary pack.
11.4 As appropriate the label shall bear the following particulars, which may
take the form of a symbol.
a) the name or trade name and address of the manufacturer;
b) the details strictly necessary for the user to identify the contents of the
pack;
c) the word "STERILE" or a statement indicating any special microbiological
state or state of cleanliness;
d) the batch number, preceded by the word LOT or the serial number;
e) if necessary, an indication of the date by which the receptacle or part of it
Annex A
(Normative)
Test for nominal liquid capacity and graduation marks, for non-
evacuated blood specimen receptacles
A.1 Reagents and apparatus
A.1.1 Water, which complies with GB/T 6682, at 20 °C to 25 °C.
A.1.2 Burette, 50 mL capacity, graduated in 0.1 mL increments (accurate to 0.1
mL), with a tap at the bottom or side.
A.1.3 Analytical balance with an accuracy of ± 0.001 g and of sufficient weighing
capacity for the test.
A.1.4 Rack to keep the receptacle upright during weighing (optional).
A.2 Test conditions
A.2.1 The test shall be carried out in ambient conditions of 101 kPa and 20 °C;
making appropriate corrections if other conditions prevail.
A.2.2 The receptacle to be tested shall be unused and have a fill line or
graduation lines.
A.3 Test procedure (gravimetric analysis)
A.3.1 CLOSE the tap on the burette, FILL it with an appropriate amount of water...