Assessing the biocompatibility of medical devices and materials with ISO 10993-1
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 assess 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 10993-1 Biological evaluation of medical devices
ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process, is the most widely used standard for assessing the biocompatibility of medical devices and materials, and 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 hemocompatibility, etc.
Biocompatibility testing shall be conducted in compliance with Principles of Good Laboratory Practice (GLP) and/or ISO/IEC 17025.
how we can help
TÜV SÜD laboratories offer a comprehensive range of GLP-compliant biocompatibility testing services according to the ISO 10993 series of standards, including biocompatibility studies and chemical-related testing services. In addition, 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.
- Submission Forms for regulatory data compilations – TÜV SÜD Product Service Global Service assures by guiding submission documents for the whole 10993 standard Series that regulative requirements are covered by data provided by the clients. This minimizes the risk of delays during conformity assessment due to missing data to a minimum by clear communicated transparent requirements.
- GLP-compliant biocompatibility testing - TÜV SÜD laboratories conduct biocompatibility tests in compliance with GLP Principles.
- Product safety testing and certification - TÜV SÜD Product Service is an EU Notified Body for medical devices, and is recognized by other regulatory agencies throughout the world for its extensive experience with a broad range of medical devices.
- 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.
- FDA 510(k) third party review service - TÜV SÜD Product Service has participated in the FDA 510(k) third-party review program since its inception in 1996, and offers third-party submission reviews for over 600 devices. TÜV SÜD medical device experts maintain close contact with FDA reviewers to ensure that issues are promptly addressed, resulting in a more efficient review process and timely product clearance.
- Other testing and certification services - In addition to biocompatibility assessments required for medical devices, TÜV SÜD Product Service can also provide compliance testing for medical devices in accordance with other relevant regulations and standards.
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Your benefits at a glance
- Recognized medical device expertise - TÜV SÜD Product Service is the largest EU Notified Body in the world. With a Regulatory Foreign Affairs and Clinical Centre of Excellence, TÜV SÜD Product Service is recognized by regulatory authorities around the world for its extensive experience with all types of medical devices.
- Quality system certification and auditing expertise - Medical device approvals routinely require the implementation of a quality management system. TÜV SÜD Product Service conducts quality management system certifications, audits and factory inspections consistent with most international regulations and standards, allowing clients to enjoy the benefits of coordinated inspections and audits, while reducing downtime and costs.
- 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. TÜV SÜD Product Service is also a member of Team NB, the European Association for Medical Devices of Notified Bodies, which facilitates the exchange of information on standards and regulations applicable to medical devices.
- Single source solution - TÜV SÜD Product Service offers testing services for major medical device markets according to international standards and regulations.
- 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.
