YY/T 0314-2021Single-use containers for human venous blood specimen collection (English PDF)

3.1 accessory

component inside the container which is intended by the manufacturer to assist in the collection, or mixing, or separation of the specimen

Note: 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 in order to facilitate the creation of the desired sample

3.3 closure

component by which the container is sealed, which may consist of several parts

3.4 container

vessel, whether evacuated or not, intended to contain a specimen, together with any container accessory and additive, with closure in place

3.5 container interior

inner surface of the container exposed to the specimen

3.6 draw volume

volume of whole blood that will be collected in the container

3.7 evacuated container

container 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 or its label to indicate the correct filling

3.10 free space

space above the drawn sample

3.11 nominal liquid capacity

draw volume plus volume of additive not including any accessories

3.12 primary colour

dominant colour of closure component most representative of the additive in the container

Note: Dominant is the colour of the closure that covers the majority of the surface.

3.13 primary pack

smallest package of containers

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

3.16 tube

part of the container, without the closure, that contains the specimen

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

4.1

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.

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 shall 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.