Disposable vacuum blood collection tube’s standard
4.1.4 structure
4.1.4.1 the blood collection tube shall be able to withstand 4 times of removing and installing the plug. When tested according to Appendix A, Appendix B, Appendix C and Appendix D of yy0314-2007, the blood collection tube shall be free of fracture, collapse, rupture or other visible damage. If the plug is damaged when the blood collection tube is opened for the first time, these requirements still apply to the plug.
4.1.4.2 when the blood collection tube expected to be subjected to centrifugation is tested according to Appendix D of YY 0314-2007, the longitudinal axis of the blood collection tube shall be able to withstand the centrifugal acceleration of at least 3000g without fracture, collapse, crack or other visible defects.
4.1.4.3 during visual inspection, there shall be no sharp edge, burr or rough surface on the blood collection tube that can cause the user's skin or gloves to be accidentally scratched, punctured or abraded.
Test method: according to Appendix D and visual inspection of YY 0314-2007.
4.2 nominal liquid capacity
4.2.1 when testing according to the method in Appendix B of YY 0314-2007, the volume of water added or extracted from the burette plus the volume of additives shall be between 90% - 110% of the nominal capacity.
4.2.2 free space for shaking mixing or other physical mixing methods shall be provided for the blood collection tubes with additives.
4.2.3 when mixing in free space, enough free space for mechanical or manual mixing shall be reserved. (the capacity is under the standard atmospheric pressure, i.e. 760mmhg. If other environmental conditions are used, it shall be corrected.).
Test method: conduct the test according to Appendix B of yy0314-2007.
4.3 additives
4.3.1 the actual amount of additives in each blood collection tube shall be within the range specified by the manufacturer.
4.3.2 the maximum allowable tolerance of liquid additives shall be 90% - 110% of the specified volume.
4.3.3 ensure that the physical form of the additive is suitable for its purpose.
4.3.4 it shall be ensured that the expected mixing ratio of blood and additives can always be met during the storage period of the product.
5 inspection rules
5.1 type inspection
5.1.1 type test shall be conducted under the following conditions:
a) Product registration;
b) Continuous production for more than half a year;
c) Major changes in structure, key parts and components and process;
d) When production is resumed after half a year of shutdown;
e) When specified in the contract or required by the supervision and management department.
5.1.2 the type test items shall comply with Chapter 4, and all 5 randomly sampled samples shall be qualified.
5.2 delivery inspection
5.2.1 each batch of products must be inspected and can be delivered after passing the inspection.
5.2.2 for each batch of products, 50 pieces shall be sampled by random sampling method for inspection in 4.1 and 4.2. All products must be qualified.
(6) information provided by the manufacturer
It shall meet the requirements of Chapter 11 of YY 0314-2007.
(7) identification of blood collection tubes and additives
It shall meet the requirements in Chapter 12 of YY 0314-2007.
Preparation instructions for registered product standard of disposable vacuum blood collection tube
According to the market and user requirements, our company has developed the disposable vacuum blood collection tube, which is mainly used for clinical blood collection in combination with the disposable venous blood collection needle. This product replaces the original syringe for blood collection. It is convenient, safe and easy to operate, and is welcomed by users. The company formulates this standard according to yy0314 standard and GB / T1.1-2000. The following standards are cited in this standard:
GB / t191-2008 pictorial signs for packaging, storage and transportation
Gb9890 medical rubber plug
Yy0314-2007 disposable venous blood sample collection container
WS / t224-2002 vacuum blood collection tube and its additives
Yy0466-2003 medical devices: symbols for labeling, marking and providing information of medical devices.
Post time: Aug-24-2022
