EN ISO 10993-6:2016

European foreword
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Common provisions for implantation test methods
5 Test methods, general aspects
6 Test report
Annex A (normative) - Test methods for
        implantation in subcutaneous tissue
Annex B (normative) - Test method for implantation
        in muscle
Annex C (normative) - Test method for implantation
        in bone
Annex D (normative) - Test method for implantation
        in brain tissue
Annex E (informative) - Examples of evaluation of local
        biological effects after implantation
Bibliography
Annex ZA (informative) - Relationship between this
         European Standard and the essential
         requirements of Directive 93/42/EEC
         [OJ L 169] aimed to be covered
Annex ZB (informative) - Relationship between this
         European Standard and the essential
         requirements of Directive 90/385/EEC
         [OJ L 189] aimed to be covered

ISO 10993-6:2016 specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices.ISO 10993-6:2016 applies to materials that are- solid and non-absorbable,- non-solid, such as porous materials, liquids, gels, pastes, and particulates, and- degradable and/or absorbable, which may be solid or non-solid.The test sample 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 sample in terms of mechanical or functional loading. This part of ISO 10993 can also be applied to medical devices that are intended to be used topically in clinical indications where the surface or lining might 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 sample to that caused by control materials used in medical devices whose 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 absorption/degradation of the material. In particular for degradable/absorbable materials, the degradation characteristics of the material and the resulting tissue response should be determined.ISO 10993-6:2016 does not deal with systemic toxicity, carcinogenicity, teratogenicity or mutagenicity. However, the long-term implantation studies intended for evaluation of local biological effects might provide insight into some of these properties. Systemic toxicity studies conducted by implantation might satisfy the requirements of this part of ISO 10993. When conducting combined studies for evaluating local effects and systemic effects, the requirements of both standards is to be fulfilled.