YY/T 1806.1-2021Evaluation method for in vitro degradation performance of biomedical materials - Part 1: Degradable polyester (English PDF)

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules of Standardization Documents" drafted.

This document is part 1 of YY/T 1806 "Methods for Evaluation of In Vitro Degradation Properties of Biomedical Materials". YY/T 1806 has been released the following parts.

--- Part 1: Degradable polyesters;

--- Part 2: Mussel mucin.

Introduction

Degradable polyester is a kind of chemically synthesized polymer biomaterial with good biodegradability and biocompatibility. required biomedical materials. Its degradation behavior includes degradation rate, product formation, morphology, and mechanical properties changes during the degradation process. Product safety and efficacy are closely related.

Degradable polyesters may be homopolymers, copolymers or blends, and the degradation principle is mainly the hydrolysis of ester bonds. Types of materials, chemical groups The composition, structure, configuration, molecular chain length, crystallinity, physical morphology (thickness, pores), etc. are all internal factors that affect the degradation rate. In addition, the environment Temperature, humidity, pH of test solution, ratio of sample to test solution, etc. will also affect its in vitro degradation. establish a suitable method for The evaluation of the in vitro degradation behavior of degradable polyester raw materials or final products can provide data support for material modification and process optimization.

Due to the variety and application of degradable polyester medical materials, this document cannot give specific tests applicable to all materials. method. When conducting in vitro degradation studies of specific products, this document can be referred to when applicable. In addition to the methods recommended in this document Other methods can also be used, but the user of this document is responsible for proper demonstration before use to ensure that the method is feasible and reliable.

YY/T 1806 aims to establish a method for evaluating the in vitro degradation performance of biomedical materials, and is intended to consist of two parts.

--- Part 1: Degradable polyesters. The purpose is to evaluate the in vitro degradation performance of degradable polyester biomedical materials/devices. price method.

--- Part 2: Mussel mucin. The purpose is to evaluate the in vitro degradation performance of mussel mucin biomedical materials/devices method.

1 Scope

This document specifies the degradation principle of glycolide, lactide, epsilon-caprolactone and other homopolymers, copolymers or blends whose degradation principle is mainly hydrolysis of ester bonds. Methods for evaluating the degradation properties of biomedical materials/devices.

This document is applicable to the evaluation of in vitro degradation performance of degradable polyester biomedical materials/devices.

2 Normative references

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document.

GB/T 1632.1 Plastics use capillary viscometer to determine the viscosity of dilute polymer solutions - Part 1: General

GB/T 6682 Analysis Laboratory Water Specifications and Test Methods Pharmacopoeia of the People's Republic of China (four volumes of the 2020 edition)

3 Terms and Definitions

The following terms and definitions apply to this document.

4 In vitro degradation test design