GB/T 16886.6-2022
Biological evaluation of medical devices—Part 6:Tests for local effects after implantation (English Version)

Standard No.

GB/T 16886.6-2022

Language

Chinese, Available in English version

Release Date

2022

Published By

国家市场监督管理总局、中国国家标准化管理委员会

Latest

GB/T 16886.6-2022

Replace

GB/T 16886.6-2015

Scope

This document specifies test methods for evaluating local reactions after implantation of biomaterials used in medical devices. This document applies to the following materials: --- solid and non-solid materials, such as porous materials, liquids, gels, pastes and granular materials, --- non-absorbent materials, and --- degradable and/or absorbable solid or non-solid materials. This document is also applicable to the evaluation of local tissue responses to medical devices intended to be used clinically on locally damaged surfaces or internally damaged surfaces. Note 1: The test samples are implanted into animals of appropriate species and parts to evaluate the biological safety of the material, the purpose of which is to characterize the process and evolution of the tissue response after implantation of the medical device/biological material, including the final tissue integration of the material or Absorption/degradation, especially for degradable/absorbable materials, to determine the degradation characteristics of the material and the resulting tissue response. Local reactions are evaluated by comparing the tissue reactions produced by the test sample with reference materials used in medical devices with established clinical acceptability and biocompatibility. This document does not apply to implantation tests intended to evaluate or determine the performance of the test specimen with respect to mechanical or functional loading. This document does not address systemic toxicity, carcinogenicity, teratogenicity or mutagenicity. Note 2: Long-term implantation studies used to evaluate local biological responses may provide some information on systemic toxicity, carcinogenicity, teratogenicity or mutagenicity. Systemic toxicity studies by implantation may meet the requirements of this document. When conducting joint studies to evaluate local and systemic reactions, the requirements of both documents must be met.

GB/T 16886.6-2022 Referenced Document

• ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
• ISO 10993-2 Biological evaluation of medical devices — Part 2: Animal welfare requirements*， 2022-11-03 Update
• ISO 10993-4 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood — Amendment 1

GB/T 16886.6-2022 history

• 2022 GB/T 16886.6-2022 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation
• 2015 GB/T 16886.6-2015 Biological evaluation of medical devices.Part 6:Tests for local effects after implantation
• 1997 GB/T 16886.6-1997 Biological evaluation of medical devices--Part 6: Tests for local effects after implantation

GB/T 16886.6-2022 -All Parts