1 Scope
This part of GB/T 16886 specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices.
This part applies to materials that are:
——solid and non-biodegradable;
——degradable and/or resorbable;
——non-solid, such as porous materials, liquids, pastes and particulates.
The test specimen is implanted into a site and animal species appropriate for the evaluation of the biological safety of the material. These implantation tests are not intended to evaluate or determine the performance of the test specimen in terms of mechanical or functional loading. This part of GB/T 16886 may also be applied to medical devices that are intended to be used topically in clinical indications where the surface or lining may have been breached, in order to evaluate local tissue responses.
The local effects are evaluated by a comparison of the tissue response caused by a test specimen to that caused by control materials used in medical devices of which the clinical acceptability and biocompatibility characteristics have been established. The objective of the test methods is to characterize the history and evolution of the tissue response after implantation of a medical device/biomaterial including final integration or resorption/degradation of the material. In particular for degradable/resorbable materials the degradation characteristics of the material and the resulting tissue response should be determined.
This part does not deal with systemic toxicity, carcinogenicity, teratogenicity or mutagenicity. However, the long-term implantation studies intended for evaluation of local biological effects may provide insight into some of these properties. Systemic toxicity studies conducted by implantation may satisfy the requirements of this part of GB/T 16886.
2 Normative References
The following referenced documents are indispensable for the application 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.
ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management System
ISO 10993-2 Biological Evaluation of Medical Devices - Part 2: Animal Welfare Requirements
ISO 10993-11 Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity
ISO 10993-12 Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials
ISO 10993-16 Biological Evaluation of Medical Devices - Part 16: Toxicokinetic Study Design For Degradation Products and Leachables
3 Terms and Definitions
For the purposes of this document, the terms and definitions given in ISO 10993-1, ISO 10993-2, ISO 10993-12, ISO 10993-16 and the following apply.
Foreword i
1 Scope
2 Normative References
3 Terms and Definitions
4 Common Provisions for Implantation Test Methods
5 General Aspects of Test Methods
6 Test Report
Annex A (Informative) General Considerations Regarding Implantation Periods and Tissue Responses to Degradable/Resorbable Materials
Annex B (Normative) Test Methods for Implantation in Subcutaneous Tissue
Annex C (Normative) Test Method for Implantation in Muscle
Annex D (Normative) Test Method for Implantation in Bone
Annex E (Informative) Examples of Evaluation of Local Biological Effects after Implantation
Bibliography
