DIN Standards Committee Optics and Precision Mechanics
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
Abstract
This document specifies requirements for implantation test methods for preclinical assessment of the local effects after implantation of materials intended for use in medical devices. In order to evaluate local tissue responses from medical devices that are intended to be used where skin or mucosal tissue is breached, this document is applicable when required. This document applies to medical device/materials that require implantation evaluation and can be solid or non-solid (such as porous materials, liquids, gels, pastes, powders, and particulates), absorbable/degradable or non- absorbable, or can be tissue-engineered medical products (TEMPs). These implantation tests are not intended to evaluate or determine the performance of the test sample in terms of mechanical loading or functional performance. This document also does not provide guidance on methods and study design to satisfy requirements for systemic toxicity, carcinogenicity, teratogenicity or mutagenicity. However, the study designs can be modified to also assess other biocompatibility effects.
Begin
2023-01-27
WI
00206097
Planned document number
DIN EN ISO 10993-6
Project number
02703392
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
