Biocompatibility evaluation

Purpose

The aim of the biological safety evaluation is to ensure that possible negative effects on human health caused by the materials in the product shall be identified and managed. We are a dedicated collaboration partner with solid knowledge about current regulations, available test methods and good test strategies. We are also the only laboratory in Sweden to offer cell based test methods according to the quality system Good Laboratory Practice (GLP) to external customers.

In the EU and in the US, the legislative requirements for biocompatibility of materials in medical devices are similar. The standard series ISO 10993, describing test strategies and – methods to ensure biocompatibility, is combined with the standard ISO 14971, which concerns risk management for medical devices. These two standards form the framework for generating a biological safety evaluation plan.

Method

Generating a biological safety evaluation plan is performed in several steps:

• Planning and executing a biocompatibility evaluation according to ISO 10993-1, choice of suitable methods and waiving of certain tests.
• Toxicological evaluation of included parts and chemical substances according to ISO 10993-17 and relevant regulations.
• Determination of leachables and/or extractables from ceramic, metallic or polymeric materials according to ISO 10993-18.
• Chemical characterisation of included materials with techniques such as FTIR, DSC, XRF, CHN, XRD, surface area determinations, polymer molecular weight determination, etc, according to ISO 10993-19.
• Determination of degradation products from materials according to ISO 10993-9, ISO 10993-13, ISO 10993-14, and ISO 10993-15.
• Biological testing of materials according to ISO 10993-1, such as cytotoxicity, skin sensitization and skin irritation.
• Risk evaluation and risk management plans for residual risk.

RISE has extensive personnel and instrumental resources available, to perform all steps up to a complete biological safety evaluation plan.

Deliveries

Results from testing or evaluation are presented in one or several reports in Swedish or in English as agreed with the customer. For tests performed according to GLP, a study plan is set up before the start of the test.