ISO 10993 Biological Evaluation of Medical Devices

EVALUATING the biocompatibility of medical devices and materials with ISO 10993

A medical device or material that comes in contact with the patient's body is expected to perform its intended function without resulting in any adverse effect to a patient. Potential adverse effects can range from short-term (acute) to long-term (chronic) adverse effects to the body such as mutagenic effects. For this reason, medical devices are typically subject to biological evaluation and biocompatibility testing to evaluate the interaction between a device and tissue, cells or body fluids of the patient. The primary purpose of a device biocompatibility assessment is to protect patient from potential biological risks.

ISO 10993 Biological evaluation of medical devices

ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process provides a framework for determining the appropriate biocompatibility steps for planning a biological evaluation. Specific testing is dependent on the type of medical device or material and its intended use, and on the nature and duration of contact between the medical device and the body. According to the standard, an assessment for biological effects from the exposure of a medical device or material to human body can include testing such as cytotoxicity, sensitization, irritation or intracutaneous reactivity, systemic toxicity, subchronic toxicity, genotoxicity, implantation and haemocompatibility, etc.

Biocompatibility testing shall be conducted in compliance with Principles of Good Laboratory Practice (GLP) and/or ISO/IEC 17025.

Why choose TÜV SÜD

TÜV SÜD Product Service’s industry specialists and clinical practitioners have extensive experience with all types of medical devices, and the compliance of regulatory requirements for medical devices in major medical device markets.

Our services at a glance

• Conformity assessment of data on biocompatibility – TÜV SÜD experts provide regulatory review of validation protocols for compliance to state of the art biocompatibility standards within conformity assessment procedures.
• Submission Forms for regulatory data compilations – TÜV SÜD assures by guiding submission documents for the whole 10993 standard series. This minimizes the risk of delays during assessments due to missing data to a minimum by clear communicated transparent requirements.
• Risk management expertise - TÜV SÜD Product Service and TÜV SÜD experts have extensive experience in every aspect of risk management systems for medical device manufacturers in accordance with ISO 14971 and conduct thousands of in-depth risk management audits each year.

Your benefits at a glance

• Recognised medical device expertise - TÜV SÜD Product Service is recognised around the world for its extensive experience with all types of medical devices. All TÜV SÜD experts stand for highest quality and have a strong educational and professional background. 
• Active involvement in standards development and implementation - TÜV SÜD Product Service technical professionals are actively involved in standards development activities related to medical devices, and participate in a number of key standards committees. 

• Expert partnership - TÜV SÜD Product Service has a long record of technical and regulatory expertise for medical devices, and is a trusted partner to companies ranging from global manufacturers to regional and local research and development firms.