YY 0314-2007Single-use containers for human venous blood specimen collection (English PDF)

3.1 additive

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.

4.1

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.

10.4

The manufacturer shall ensure that the intended blood/additive ratio is

obtainable throughout the shelf- life of the product.

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 […]

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.

A.3.2 REMOVE the receptacle closure, WEIGH the container.

A.3.3 POSITION the container under the delivery jet of the burette.

A.3.4 Carefully RUN the water into the container, until the meniscus is level with the minimum fill line (if present), or the fill line of the container, then CLOSE the tap and REWEIGH the receptacle.

A.3.5 REPEAT steps A.3.3 and A.3.4 for each graduation line until the meniscus reaches the maximum fill line.

A.4 Result representation

The volume of water filled is calculated by the difference between the two weighing values before and after filling water filling to each graduation line (see

3.12).

B.1 Reagents and apparatus

B.1.1 Water, which complies with GB/T 6682, at 20 °C to 25 °C.

B.1.2 Analytical balance accurate to 0.001 g and of sufficient weighing capacity for the test.

B.1.3 Needle holder assembly as recommended by the manufacturer of the receptacle.

B.1.4 Rack to keep the evacuated receptacle upright during weighing (optional).

B.2 Test conditions

B.2.1 The test shall be carried out in ambient conditions of 101 kPa and (20 ±

2) °C; making appropriate corrections if other conditions prevail.

NOTE 1: If ambient atmospheric pressure is not 101 kPa, it is recommended to use

Annex NA to calibrate the ambient atmosphere.

NOTE 2: This test does not apply to evacuated receptacles used in high altitude areas.

For pre-evacuated receptacles “intended for use at high altitude”, it is recommended that the test methods given in Annex NB be used under the conditions specified in this subclause.

B.2.2 The container and needle holder assembly to be tested shall be unused.

B.3 Test procedure

B.3.1 WEIGH the receptacle.

B.3.2 ASSEMBLE the needle-holder assembly, if not supplied ready assembled, in accordance with the manufacturer's instructions. If not provided as a pre- evacuated receptacle, evacuate to the nominal draw volume.

B.3.3 INTRODUCE the needle into the water. VENT the receptacle for at least

1 min, or fill as specified by the manufacturer's instructions.

B.3.4 REMOVE needle and holder, DRY the outside of the receptacle (if necessary), and RE-WEIGH the receptacle to determine the amount of water drawn.

D.1 Reagents and apparatus

D.1.1 Water, which complies with GB/T 6682, at 20 °C to 25 °C.

D.1.2 Swing-out arm centrifuge, which is capable of subjecting the base of the container to a (longitudinal) centrifugal acceleration of 3000 gn for 10 min, or acceleration as specified by the manufacturer.

NOTE: gn = 9.806 65 m/s

2

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D.2 Test conditions

D.2.1 The test shall be carried out in ambient conditions of 101 kPa and 20 °C.

If other conditions prevail, make appropriate corrections.

D.2.2 The receptacle to be tested shall be unused.

D.3 Test procedure

D.3.1 According to the method specified by the manufacturer, FILL the receptacle with the nominal capacity of water, REMOVE and replace the closure if necessary. DRAW the nominal capacity of water into evacuated receptacles not supplied pre-evacuated.

D.3.2 SUPPORT the receptacle in the centrifuge bucket according to the manufacturer's instructions and ensure that the centrifuge is properly balanced.

D.3.3 CENTRIFUGE the filled receptacle, subjecting the base of it to a longitudinal centrifugal acceleration of 3000 gn for 10 min, or as specified by the manufacturer, excluding the time taken to reach the specified acceleration.

D.3.4 After the centrifuge has stopped, carefully remove the receptacle from the bucket and examine for physical damage.