1 Scope

This document specifies requirements for implantation test methods for preclinical assessment of the local effects after implantation of medical devices or materials intended for use in medical devices. This document is applicable to the evaluation of local tissue responses from medical devices that are intended to be used where skin or mucosal tissue is breached, when required.

This document is applicable to medical device or materials that require implantation evaluation and can be solid or non-solid (such as porous materials, liquids, gels, pastes, powders, and particulates), absorbable, degradable, non- absorbable, or can be tissue-engineered medical products (TEMPs).

These implantation tests are not intended to evaluate or determine the performance of the test sample in terms of mechanical loading or functional performance. This document also does not provide guidance on methods and study design to satisfy requirements for systemic toxicity, carcinogenicity, teratogenicity or mutagenicity. However, the study designs can be modified to also assess other biological effects.