Biologisk värdering av medicintekniska produkter

Kommittébeteckning: SIS/TK 340 (Implantat och biologisk säkerhet)
Källa: CEN
Svarsdatum: den 8 jul 2018
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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 considers 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) 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 thus need to 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.

Kommittébeteckning: SIS/TK 340 (Implantat och biologisk säkerhet)
Källa: CEN
Svarsdatum: den 8 jul 2018
Se merSe mindre
 

This document provides guidance on general requirements for the design of tests for identifying and quantifying degradation products from final metallic medical devices or corresponding material samples finished as ready for clinical use.

This document is applicable only to those degradation products generated by chemical alteration of the final metallic device in an in vitro accelerated degradation test. Because of the accelerated nature of these tests, the test results may not reflect the implant or material behavior in the body. The described chemical methodologies are a means to generate degradation products for further assessments.

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

This document is not applicable to degradation products induced by applied mechanical stress.

Mechanically induced degradation, such as wear, can be covered in the appropriate product-specific standard. Where product-group standards provide applicable product-specific methodologies for the identification and quantification of degradation products, those standards should be considered.

Because of the wide range of metallic materials used in medical devices, no specific analytical techniques are identified for quantifying the degradation products. The identification of trace elements (< 10 –6 w/w) contained in the specific metal or alloy is not addressed in this part of ISO 10993, nor are specific requirements for acceptable levels of degradation products provided in this part of ISO 10993.

This document does not address the biological activity of the degradation products; see instead the applicable clauses of ISO 10993-1 and ISO 10993-17.