What is the ISO 10993 biocompatibility testing standard used for PEEK
With the rapid development of medical technology, the application of new materials has brought revolutionary changes to the medical field. Among them, polyetheretherketone (PEEK), as a high-performance thermoplastic, has attracted great attention in the field of medical implant materials due to its unique chemical characteristics and excellent physical properties. However, as a medical material in direct contact with the human body, the biocompatibility, safety, and reliability of PEEK implant materials are crucial. For this purpose, PEEK implant materials need to comply with the ISO 10993 series standards issued by the International Organization for Standardization (ISO), which is an important criterion for measuring the biocompatibility of medical devices.In this article, let us introduce to you what is ISO 10993.
ISO 10993, biocompatibility, refers to the mutual adaptability between medical materials and the tissues and physiological systems of patients. The success and safety of medical materials in clinical practice is mainly due to their good biocompatibility. Often, some medical materials release toxic substances during use, resulting in incompatibility with the patient. To monitor biocompatibility, medical materials and extracts are often simulated for use under bad conditions to ensure safety under normal use conditions. ISO 10993, Parts 1 to 20, specifies a series of mandatory criteria to evaluate the biocompatibility of medical materials.
Main parts of ISO 10993 series standards and their contents
ISO 10993-1: General guidelines for biocompatibility assessment. The standard provides an overall framework and basic principles for biological evaluation of medical devices, provides guidance for subsequent detailed evaluations, and specifies ethical and welfare requirements for the use of animals in biological evaluation processes.
ISO 10993-2: Animal welfare requirements. This part of the standards focuses specifically on the use and welfare of animals during biological evaluation, ensuring that animal experiments comply with ethical standards, and minimizing animal suffering and discomfort.
ISO 10993-3: Tests for genotoxicity, carcinogenicity and reproductive toxicity. These tests are used to assess whether medical device materials are likely to have genotoxic, carcinogenic, or reproductive toxic effects on human cells.
ISO 10993-4: Selection of tests for interactions with blood. This part of the standard provides principles and methods for the selection of blood interaction tests to assess the effect of medical device materials on blood, including thrombosis and platelet aggregation tests.
ISO 10993-5:Tests for in vitro cytotoxicity. To evaluate the toxic effects of medical device materials on cells through an in vitro cell culture system.
ISO 10993-6:Tests for local effects after implantation. The local reaction of the material at the implantation site, such as the reaction of muscle, bone and subcutaneous tissue, was evaluated.
ISO 10993-7:Ethylene oxide sterilization residuals. To evaluate the impact of residues in medical devices sterilized with ethylene oxide on biological systems.
ISO 10993-9: Framework for identification and quantification of potential degradation products.To identify and quantify the degradation products that may be released from medical devices during use, and to assess their biosafety.
ISO 10993-10: Tests for irritation and skin sensitization. The evaluation of whether medical device materials can cause skin allergic reactions belongs to skin irritation and allergen testing.
ISO 10993-11:Tests for systemic toxicity. To evaluate the possible effects of medical devices and biomaterials on the immune system.
In addition, the ISO 10993 series of standards includes a section for the biosafety assessment of degradation products of specific types of medical devices, such as ISO 10993-13 (degradable polymers), ISO 10993-14 (degradable ceramics), and ISO 10993-15 (degradable metals and alloys). And ISO 10993-16 (toxicological studies of degradation products, in vitro experiments) and ISO 10993-17 (quantification of extractable and extractable extracts) for quantification of extractable and extractable extracts in medical devices and assessment of their effects on human health.
In summary, ISO 10993 series standards are a comprehensive and detailed biocompatibility evaluation system for medical devices, covering multiple aspects from the general framework to the specific test methods, which provides important technical support for the research and development, production and supervision of medical devices.
The implant grade PEEK material of JUNSUN MEDICAL strictly follows and complies with the ISO 10993 series standards, making it an ideal choice for the field of medical implant materials.
