YY/T 1416.3-2016Test method for additive in single-use containers for human venous blood specimen collection - Part 3: Heparin (English PDF)

Introduction

Single-use containers for human venous blood specimen collection (abbreviated as blood-collecting vessel) and single-use needle for sterile venous blood specimen collection shall be used together. Venous blood samples shall be collected for clinical test. The use of blood-collecting vessels which contain different additives or addenda are different. Heparin is widely distributed in almost all tissues, such as lung, liver and spleen, and in the granule of mast cells and basophilic granulocytes around blood vessels. Heparin can enhance the inactivation from antithrombin III (AT-III) to serine proteases, therefore, it can prevent the formation of thrombin and prevent several kinds of anticoagulation such as platelet aggregation. Although heparin can maintain the natural morphology of red blood cells, however, it often causes leukocyte aggregation, and when smears are used for Roche staining, blue background can be produced.

Therefore, heparin anticoagulation is not suitable for general whole-hematology examinations. Heparin is the ideal anticoagulant for red-blood-cell permeability test.

YY 0314 only gives the concentration range of heparin sodium / heparin lithium. This part of YY/T 1416 gives the method for determining the amount of each additive.

This section recommends methylene blue spectrophotometric method to determine the amount of additive "heparin sodium / heparin lithium" in single blood-collecting vessel, so as to facilitate the quality control of single-use containers for human venous blood specimen collection. Other methods of measurement may also be used, but methodological confirmation shall be required.

1 Scope

This Part of YY/T 1416 specifies the experiment method of using methylene blue spectrophotometric method to determine the amount of additive "heparin" in single-use containers for human venous blood specimen collection (abbreviated as blood-collecting vessel).

This Part applies to the blood-collecting vessel whose additive is heparin lithium / heparin sodium.

2 Normative references

The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) are applicable to this standard.

GB/T6682 Water for analytical laboratory use - Specification and test method

3 Test section