Single-use containers for human capillary blood specimen collection
1 Scope
This standard specifies requirements and test methods for single-use containers for human capillary blood specimen collection (hereinafter referred to as “capillary blood container”).
This standard is applicable to the capillary blood container that is intended for single-use with a blood collection volume of 20μL to 1,000μL.
This standard is not applicable to the venous blood container, artery blood container and micro blood collection tube.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition (including any amendments) applies.
GB/T 6682 Water for analytical laboratory use - Specification and test methods
GB/T 19973.1-2015 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
YY/T 0466.1 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
tube
part of the capillary blood container, without a cap, that contains the specimen
3.2
fill indicator
line marked on a tube or its label to indicate the correct filling
3.3
capillary blood container
vessel intended to contain a specimen, together with any container accessory, additive, and cap
3.4
capillary blood container interior
inner surface of the capillary blood container exposed to the specimen
3.5
specimen
capillary blood collected in a capillary blood container
3.6
free space
additional capacity or headspace for full mixing of the substances in a capillary blood container
3.7
cap
assembly used for sealing the capillary blood container
3.8
primary colour
dominant colour of the cap, most representative of the additive in the capillary blood container
Note: Primary colour of the cap is the colour that covers the majority of the surface.
3.9
nominal liquid capacity
draw volume plus volume of additive (not including any accessories)
3.10
draw volume
volume of all blood collected in the capillary blood container according to the fill indicator
3.11
additive
substance (other than inside surface treatments designed to be irremovable) that is placed in the capillary blood container in order to facilitate the creation of the desired sample
3.12
accessory
component inside the capillary blood 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.
3.13
primary pack
minimum pack of capillary blood container
3.14
expiry date
date after which the product shall not be used
3.15
visual inspection
inspection by an observer with normal or corrected-to-normal vision without magnification under an average illuminance between 500lx and 1,000lx
3.16
relative centrifugal force; RCF
force that is generated during the specimen centrifugation process, which is specified by the manufacturer for adequate separation
4 Materials
4.1 The tube of the capillary blood container shall be transparent, allowing a clear view of the contents when subjected to visual inspection.
Note: Except for those that may cause deterioration of the content under ultraviolet or visible light.
4.2 If a capillary blood container is intended for the determination of a certain element/substance, the maximum level of the element/substance in the capillary blood container interior and the analytical method employed shall be provided by the manufacturer and stated in the instructions or on the packaging.
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Materials
5 Draw volume
6 Design
7 Construction
8 Bioburden
9 Additives
10 Marking and labelling
11 Identification of capillary blood container
Annex A (Normative) Draw volume test
Annex B (Normative) Test for leakage
Annex C (Normative) Strength test
Annex D (Informative) Recommended colour codes for identifying additives and accessories
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