Overview

This standard DIN EN ISO 10993-6 has been adopted from the work of Technical Committee ISO/TC 194 "Biological and clinical evaluation of medical devices". It specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices. It applies to materials that are - solid and non-absorbable; degradable and/or absorbable, and non-solid, such as porous materials, liquids, pastes and suspended particulates. The standard 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 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. This standard 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 standard. When conducting combined studies for evaluating local effects and systemic effects, the requirements of this standard and those of DIN EN ISO 10993-11 are to be fulfilled. Potential users of this standard are both testing institutes and manufacturers of medical devices. This standard is a test standard and is to be applied in conjunction with DIN EN ISO 10993-1 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". This standard deals in particular with aspects of quality, health protection and product safety. Committee NA 027-02-12 AA "Biologische Beurteilung von Medizinprodukten" ("Biological evaluation of medical devices") at DIN Standards Committee Optics and Precision Mechanics (NAFuO) is responsible for this standard.

Document: references other documents

Document: referenced in other documents

Responsible national committee

NA 027-07-12 AA - Biological evaluation of medical devices  

Responsible european committee

CEN/TC 206 - Biological and clinical evaluation of medical devices  

Responsible international committee

ISO/TC 194/WG 10 - Implantation