GB/T 16886.6-2015 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation

Scope

This part of GB/T 16886 specifies the test methods for evaluating the local reaction of biomaterials used in medical devices after implantation. This part applies to the following materials: -- Solid and non-biodegradable materials; -- Degradable and/or absorbable materials; -- Non-solid materials, such as porous materials, liquids, pastes, and particulate materials. The test samples are implanted in suitable animal species and locations to evaluate the biocompatibility of the materials. These implantation methods are not intended to evaluate or determine the performance of the test samples under mechanical or functional loads. This part of GB/T 16886 may also apply to medical devices intended for use on damaged surfaces or internal surfaces in clinical settings, to evaluate local tissue reactions. The local effects are evaluated by comparing the tissue reactions of the test samples with those of control materials used in established clinically acceptable and biocompatible medical devices. The purpose of the test methods in this part is to characterize the process and evolution of tissue reactions after implantation of medical devices/biomaterials, including the eventual tissue integration or absorption/degradation of the materials. For degradable/absorbable materials, it is particularly important to determine the degradation characteristics of the materials and the resulting tissue reactions. This part does not address systemic toxicity, carcinogenicity, teratogenicity, or mutagenicity. However, long-term implantation studies used to evaluate local biological effects can provide some information in this regard. Systemic toxicity studies conducted by implantation can meet the requirements of this part of GB/T 16886.

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