ISO 13781:2017 手術用インプラント—ポリ（ラクチド）上のホモポリマー、コポリマー、ブレンド—invitro分解試験 | ページ 2

Foreword

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This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 1, Materials.

This second edition cancels and replaces the first edition (ISO 13781:1997) and ISO 15814, which have been technically revised.

The main change compared to the previous edition is as follows:

• the principle contents of ISO 15814 are incorporated into this document.

Introduction

With the development of absorbable polymers for use in implantable devices, there is a need to define standard test methods to evaluate the behaviour of bulk material or devices under simulated physiological environments. On the other hand, the behaviour of absorbable materials and devices in situ depends on the conditions in which the material is implanted. These conditions differ, so that the site-specific behaviour of the material or device can differ. The interpretation of in vitro test results therefore needs to be considered carefully, taking into account any correlation of test results under in vitro and in vivo conditions. Only functional in vivo tests with the final product can answer actual degradation behaviour in situ.

1 Scope

This document describes methods for the determination of chemical and mechanical changes in poly(lactide)-based homopolymers, copolymers and/or blends induced under in vitro degradation testing conditions. This document covers polymers based on L-lactide, D-lactide, and/or D, L-lactide monomeric units.

The purpose of this document is to compare and/or evaluate materials or processing conditions. This document also describes the fundamental physical and mechanical evaluations needed for an in vitro degradation characterization of an absorbable poly(lactide) or other hydrolysable material or device.

This document is applicable to poly(lactide)-based homopolymers, copolymers and/or blends in bulk or processed forms and used for the manufacture of surgical implants, including finished products (packaged and sterilized implants).

The test methods specified in this document are also intended to determine the in vitro degradation rate and related changes in material properties of polylactide-based copolymers and/or blends with various other comonomers, such as glycolid, trimethylene, carbonate and/or ε-caprolactone. Unless otherwise validated for a specific device, these in vitro methods cannot be used to definitively predict device behaviour under in vivo conditions.

2 Normative references

The following documents are referred to in the text in such a way that some or all of their content constitutes requirements 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.

3 Terms and definitions

For the purposes of this document, the following terms and definitions apply.

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Bibliography