YY/T 1651.1-2019Tests for hemolysis of medical devices - Part 1: Material induced hemolysis assay (English PDF)

Foreword

YY/T 1651 "Medical Device Hemolysis Test" is divided into the following parts.

--- Part 1: Material-mediated hemolysis test;

--- Part 2: Mechanical force-mediated hemolysis test. This part is the first part of YY/T 1651.

This part is drafted in accordance with the rules given in GB/T 1.1-2009.

Introduction

Hemolysis of medical devices/materials refers to destruction of erythrocyte membranes caused by medical devices/materials or their solubles, free blood in plasma Increased erythroprotein, resulting in a toxic biological effect. Hemolysis of medical devices/materials is generally divided into material-mediated hemolysis and mechanical Force-mediated hemolysis in two major categories. Among them, material-mediated hemolysis tests can be divided into direct contact method and indirect contact method. Direct contact method Is the hemolysis caused by the direct contact of physical and chemical factors with red blood cells on the surface of medical devices/materials. Indirect contact refers to medical devices.

Hemolysis caused by contact of solubles with red blood cells in the device/material. Mechanical force-mediated hemolysis refers to fluid dynamics such as blood Distortion and rupture of erythrocyte membranes caused by flow rates, eddy currents, and non-physiological shear forces.

The test principles for the blood compatibility of medical devices/materials and the selection strategy for the tests are given in GB/T 16886.4, but the standards are not Give specific test methods of operation. The absorbance method specified in this section measures hemolysis method and hemoglobin concentration determination hemolysis method. Containing straight The measurement of contact hemolysis and indirect contact hemolysis is a supplement to GB/T 16886.4. The user should choose according to the intended use of the device. A suitable method for hemolysis evaluation. Medical device hemolysis test Part 1: Material mediated Hemolysis test

1 Scope

This part of YY/T 1651 specifies the absorbance method for hemolysis and the hemoglobin concentration for hemolysis.

This section applies to the evaluation of hemolysis by medical devices/materials.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this document. For undated references, the latest edition (including all amendments) applies to this document.

GB/T 16886.2 Biological evaluation of medical devices - Part 2: Animal welfare requirements (GB/T 16886.2-2011,

ISO 10993-2:2006, IDT)

GB/T 16886.4 Biological evaluation of medical devices - Part 4: Selection of test for interaction with blood (GB/T 16886.4- 2003, ISO 10993-4:2002, IDT)

GB/T 16886.12 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (GB/T 16886.12- 2017, ISO 10993-12.:2012, IDT)

3 Terms and definitions

The terms and definitions defined in GB/T 16886.2, GB/T 16886.4, and GB/T 16886.12 apply to this document.

4 Blood preparation

In this experiment, the animals were selected as healthy adult rabbits, and the common items were New Zealand white rabbits, which were not limited to males and females. Should comply with GB/T 16886.2 Claim.

About 5 mL of blood was taken from each of the 3 rabbits, collected in an anticoagulation tube and mixed together. At (4 ± 2) °C conditions before use Under the save, it is recommended to use freshly collected blood within 4 hours. Should be used up within 48h.

Note. Human blood can be selected for testing according to actual needs. Human blood must meet the requirements in accordance with the relevant health, safety and ethical requirements Eligibility criteria.

5 Absorbance determination hemolysis