Single-use containers for human venous blood specimen collection
1 Scope
This standard specifies requirements and test methods for evacuated and non-evacuated single-use containers for human venous blood specimen collection (hereinafter referred to as “container”).
This standard is applicable to evacuated and non-evacuated single-use containers for human venous blood specimen collection.
It does not specify requirements for blood collection needles and needle holders, and it is not applicable to blood culture receptacles or “arterial” blood gas collection devices that can be used for venous blood.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated reference, only the edition cited applies. For undated references, the latest edition (including any amendment) applies.
GB/T 6682 Water for analytical laboratory use - Specification and test methods (GB/T 6682-2008, ISO 3696:1987, MOD)
YY/T 0466.1 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (YY/T 0466.1-2016, ISO 15223-1:2012, IDT)
3 Terms and definitions
For the purpose of this document, the following terms and definitions apply.
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.
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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 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.
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.
Foreword i
Introduction iv
1 Scope
2 Normative references
3 Terms and definitions
4 Materials
5 Draw volume
6 Design
7 Construction
8 Sterility and special microbiological states
9 Additives
10 Marking and labeling
11 Container identification
Annex A (Normative) Draw volume test for non-evacuated containers
Annex B (Normative) Draw volume test for evacuated container
Annex C (Normative) Test for leakage of container
Annex D (Normative) Test for robustness of the container
Annex E (Informative) Concentrations of additives and volume of liquid additives
Annex F (Informative) Recommended colour codes for identifying additives and accessories
Annex G (Informative) Recommended method for calibrating ambient pressure
Annex H (Informative) Test method for draw volume of pre-evacuated containers used in high altitude areas
Bibliography
