ISO 10993-9:2019 医療機器の生物学的評価—パート9：潜在的な分解生成物の識別と定量化のためのフレームワーク | ページ 2

Foreword

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The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives ).

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This document was prepared by Technical Committee ISO/TC 194, Biological and clinical evaluation of medical devices.

This third edition cancels and replaces the second edition (ISO 10993-9:2009), which has been technically revised.

The main changes compared to the previous edition are as follows:

• a) biodegradation changed to degradation;
• b) information on test methods amended to consider nanomaterials and relevant material specific standards.

A list of all parts in the ISO 10993 series can be found on the ISO website.

Introduction

This document is intended to present the general principles on which the specific material investigations to identify and quantify degradation products described in ISO 10993-13 (polymers), ISO 10993-14 (ceramics) and ISO 10993-15 (metals and alloys) are based.

Information obtained from these studies is intended to be used in the biological evaluations described in the remaining parts of ISO 10993.

The materials used to construct medical devices can form degradation products when exposed to the biological environment, and in the body these products might behave differently to the bulk material.

Mechanical wear, which is not in scope of this document, causes mostly particulate debris, whereas non-mechanical degradation can lead to the release of free ions or to different kinds of reaction products in the form of organic or inorganic compounds.

The degradation products can be either reactive or stable and without biochemical reaction with their environment. Accumulations of substantial quantities of stable degradation products can, however, have physical effects on the surrounding tissues. Degradation products might remain at the location of their generation or might be transported within the biological environment by various mechanisms.

The level of biological tolerability of degradation products depends on their nature and concentration, and should be primarily assessed through clinical experience and focused studies. For theoretically possible, new and/or unknown degradation products, relevant testing is necessary. For well-described and clinically accepted degradation products, further investigation might not be necessary.

Note that the safety and efficacy of a medical device can be compromised as a result of any unintended or premature degradation, which should be considered in the risk management of the device.

This document can be applied to the degradation of materials used in any kind of product that falls within the definition of “medical device” in ISO 10993-1, even if such products are subject to different regulations from those applying to medical devices, e.g. the scaffold in a tissue engineered medical product, or a carrier matrix to deliver drugs or biologics.

1 Scope

This document provides general principles for the systematic evaluation of the potential and observed degradation of medical devices through the design and performance of in vitro degradation studies. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993 series.

This document is applicable to both materials designed to degrade in the body as well as materials that are not intended to degrade.

This document is not applicable to:

• a) the evaluation of degradation which occurs by purely mechanical processes; methodologies for the production of this type of degradation product are described in specific product standards, where available;

  NOTE Purely mechanical degradation causes mostly particulate matter. Although this is excluded from the scope of this document, such degradation products can evoke a biological response and can undergo biological evaluation as described in other parts of ISO 10993.

• b) leachable components which are not degradation products;
• c) medical devices or components that do not contact the patient's body directly or indirectly.

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 terms and definitions given in ISO 10993-1 and the following apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

Bibliography