YY/T 1649.1-2019Test method for interactions of medical devices with platelet - Part 1: In vitro platelet count assay (English PDF)

Foreword

YY/T 1649 "Medical Device and Platelet Interaction Test" is divided into the following sections.

--- Part 1. In vitro platelet counting method;

--- Part 2. In vitro platelet activation test. This part is the first part of YY/T 1649.

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

Introduction

The test methods for the blood compatibility of medical devices/materials and the selection strategies for the tests are given in GB/T 16886.4. But only given Choose the principle. This part of YY/T 1649 is a specific test method for in vitro platelet count, which can be used as a medical device in GB/T 16886.4.

Supplement to the evaluation of the interaction of the device/material with platelets.

As an important component of blood, platelets play a key role in preventing bleeding. The decrease in the number of platelets in the blood after contact with the device is caused by Caused by the action of platelet adsorption, aggregation or activation, it will directly affect the blood compatibility of medical devices/materials. YY/T 1649 of this Part of the method for determining in vitro platelet counts can be used to screen medical devices with potential platelet adhesion and activation. material.

1 Scope

This part of YY/T 1649 specifies the use of medical devices/materials for in vitro and platelet interaction in blood compatibility assessment. Platelet count test method used.

This section applies to the evaluation of platelet adhesion properties and activation potential on medical devices/materials.

The test system established in this section is applicable to human blood. The test is carried out using animal blood. Refer to this section and its suitability should be carried out. Argument.

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 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management (GB/T 16886.1- 2011, ISO 10993-1.:2009, 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)

3 Terms and definitions

The terms and definitions defined in GB/T 16886.1 and GB/T 16886.4 apply to this document.

4 Overview

When medical devices/materials come into contact with human blood, platelets in the blood may adhere to the surface of the medical device/material and potential Activation reaction. When the medical device/material is in contact with blood, the number of platelets in the blood is significantly reduced, indicating that platelet has occurred.

Adhesion and activation may be associated with induction of thrombosis in vivo.

5 Reagents and materials