EUROLAB laboratory provides testing and compliance services within the scope of ISO 10993-6 standard. ISO 10993-6 specifies test methods for the assessment of local effects after implantation of biomaterials intended for use in medical devices.
ISO 10993-6 applies to the following materials:
The test specimen is implanted in a suitable site and animal species for 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 ISO 10993 is also applicable to medical devices intended for topical use in clinical indications where the surface or coating may have been compromised to assess local tissue responses.
Local effects are evaluated by comparing the tissue response induced by a test sample with that caused by control materials used in medical devices with established clinical acceptability and biocompatibility.
The purpose of testing methods is to characterize the history and evolution of tissue response after implantation of a medical device/biomaterial, including eventual integration or absorption/degradation of the material. Particularly for degradable/absorbable materials, the degradation properties of the material and the resulting tissue response should be determined.
ISO 10993-6 does not deal with systemic toxicity, carcinogenicity, teratogenicity or mutagenicity. However, long-term implantation studies to assess local biological effects may provide insight into some of these properties.
Systemic toxicity studies conducted by implantation may meet the requirements of this part of ISO 10993. When conducting combined studies to assess local effects and systemic effects, the requirements of both standards should be met.
EUROLAB assists manufacturers with ISO 10993-6 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.
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EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
