This document specifies the blood compatibility tests of haemodialysers.
It is applicable to the blood compatibility test of medical devices such as hemodialysers, hemofilters and blood concentrators with hollow fiber membrane as the main body.
2 Normative references
The following documents contain provisions which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 16886.1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
GB/T 16886.4 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
GB/T 16886.12 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
3 Terms and definitions
For the purposes of this document, the terms and definitions given in GB/T 16886.1, GB/T 16886.4 and GB/T 16886.12 apply.
4 Coagulation, platelet, complement system and haematology test of haemodialysers
4.1 General
This clause focuses on the coagulation, platelet, complement system and haematology test of hollow fiber (the core part of haemodialysers). The test methods for other components of haemodialysers, such as end cover and sealant, may refer to those specified in this document by taking a proportional portion of each component. If necessary, plasma may also be used to test the coagulation, and serum may be used to test the activation of the complement system.
The hollow fiber rinsing method specified below is applicable to haemodialysers without preservation solution, and the haemodialysers without preservation solution are adopted for product control. Haemodialysers with preservation solution may be tested after pre-rinsing according to clinical use mode, without rinsing again. Haemodialysers with preservation solution should be selected for product control.
4.2 Test principle
The changes of coagulation, platelet, complement system and hematology of anticoagulant fresh blood are detected after gentle and dynamic contact with hollow fiber membrane in vitro for a certain period of time.
4.3 Reagents and test control materials
4.3.1 Reagents
0.9% sodium chloride solution, 3.8% sodium citrate solution, cobra venom factor, reagents for hematology analyzer, prothrombin time (PT) reagent, activated partial thromboplastin time (APTT) reagent, fibrinogen (Fbg) reagent, rabbit cephalin, complement split products from C3 (C3a) enzyme linked immunosorbent assay kit, amount of complement required to lyse 50% of a RBC suspension (CH50) kit, product of terminal pathway complement activation (Sc5b-9) enzyme linked immunosorbent assay kit.
Preparation method of 3.8% sodium citrate solution: weigh a certain mass of sodium citrate dihydrate, add purified water according to the ratio of 3.8g/100mL, shake and mix until completely dissolved.
4.3.2 Test control materials
4.3.2.1 Blank control: freshly taken anticoagulant blood, without other treatment.
4.3.2.2 Negative control: blood collection tube without hollow fibers.
4.3.2.3 Positive control: blood collection tube with thrombin (Fbg reagent) and cobra venom factor is used as positive control for platelet count and complement system activation, and the specific amount added is determined by each laboratory (such as Fbg reagent of Siemens, 100μL Fbg reagent can be added to 2mL of blood; cobra venom factor of Shanghai Boyao Biotechnology Co., Ltd., 25μg can be added to 2mL blood) independently; 30cm2 of latex gloves is added as a positive control for partial thromboplastin time (PTT). Each laboratory may also determine the positive control independently.
4.3.2.4 Product control: hollow fibers in marketed haemodialysers.
4.4 Instruments and test apparatus
4.4.1 Instruments
Digital projector, rotary incubator, constant temperature incubator, hematology analyzer, coagulation analyzer, biochemical analyzer, microplate reader.
Foreword i Introduction ii 1 Scope 2 Normative references 3 Terms and definitions 4 Coagulation, platelet, complement system and haematology test of haemodialysers 5 Vitro thrombogenesis test of haemodialysers 6 Haemocompatibility test of haemodialysers
Blood compatibility tests of haemodialysers
1 Scope
This document specifies the blood compatibility tests of haemodialysers.
It is applicable to the blood compatibility test of medical devices such as hemodialysers, hemofilters and blood concentrators with hollow fiber membrane as the main body.
2 Normative references
The following documents contain provisions which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 16886.1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
GB/T 16886.4 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
GB/T 16886.12 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
3 Terms and definitions
For the purposes of this document, the terms and definitions given in GB/T 16886.1, GB/T 16886.4 and GB/T 16886.12 apply.
4 Coagulation, platelet, complement system and haematology test of haemodialysers
4.1 General
This clause focuses on the coagulation, platelet, complement system and haematology test of hollow fiber (the core part of haemodialysers). The test methods for other components of haemodialysers, such as end cover and sealant, may refer to those specified in this document by taking a proportional portion of each component. If necessary, plasma may also be used to test the coagulation, and serum may be used to test the activation of the complement system.
The hollow fiber rinsing method specified below is applicable to haemodialysers without preservation solution, and the haemodialysers without preservation solution are adopted for product control. Haemodialysers with preservation solution may be tested after pre-rinsing according to clinical use mode, without rinsing again. Haemodialysers with preservation solution should be selected for product control.
4.2 Test principle
The changes of coagulation, platelet, complement system and hematology of anticoagulant fresh blood are detected after gentle and dynamic contact with hollow fiber membrane in vitro for a certain period of time.
4.3 Reagents and test control materials
4.3.1 Reagents
0.9% sodium chloride solution, 3.8% sodium citrate solution, cobra venom factor, reagents for hematology analyzer, prothrombin time (PT) reagent, activated partial thromboplastin time (APTT) reagent, fibrinogen (Fbg) reagent, rabbit cephalin, complement split products from C3 (C3a) enzyme linked immunosorbent assay kit, amount of complement required to lyse 50% of a RBC suspension (CH50) kit, product of terminal pathway complement activation (Sc5b-9) enzyme linked immunosorbent assay kit.
Preparation method of 3.8% sodium citrate solution: weigh a certain mass of sodium citrate dihydrate, add purified water according to the ratio of 3.8g/100mL, shake and mix until completely dissolved.
4.3.2 Test control materials
4.3.2.1 Blank control: freshly taken anticoagulant blood, without other treatment.
4.3.2.2 Negative control: blood collection tube without hollow fibers.
4.3.2.3 Positive control: blood collection tube with thrombin (Fbg reagent) and cobra venom factor is used as positive control for platelet count and complement system activation, and the specific amount added is determined by each laboratory (such as Fbg reagent of Siemens, 100μL Fbg reagent can be added to 2mL of blood; cobra venom factor of Shanghai Boyao Biotechnology Co., Ltd., 25μg can be added to 2mL blood) independently; 30cm2 of latex gloves is added as a positive control for partial thromboplastin time (PTT). Each laboratory may also determine the positive control independently.
4.3.2.4 Product control: hollow fibers in marketed haemodialysers.
4.4 Instruments and test apparatus
4.4.1 Instruments
Digital projector, rotary incubator, constant temperature incubator, hematology analyzer, coagulation analyzer, biochemical analyzer, microplate reader.
Contents of YY/T 1920-2023
Foreword i
Introduction ii
1 Scope
2 Normative references
3 Terms and definitions
4 Coagulation, platelet, complement system and haematology test of haemodialysers
5 Vitro thrombogenesis test of haemodialysers
6 Haemocompatibility test of haemodialysers
