BS EN ISO 13356:2015

## Overview of BS EN ISO 13356:2015BS EN ISO 13356:2015 is the British Standard for 'Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)'. This standard specifies the requirements for yttria-stabilized tetragonal zirconia (Y-TZP) ceramic materials used in the manufacture of implantable medical devices, such as joint replacements and dental implants.### Key Benefits of BS EN ISO 13356:2015- Ensures the quality, safety, and performance of Y-TZP ceramic implants- Provides standardized testing methods and acceptance criteria- Supports regulatory compliance for medical device manufacturers- Promotes patient safety and positive clinical outcomes- Enables international trade and acceptance of certified products### Technical SpecificationsBS EN ISO 13356:2015 covers the following key technical requirements:- Chemical composition and microstructure of Y-TZP ceramics- Mechanical properties, including flexural strength, fracture toughness, and hardness- Biological safety evaluation, including cytotoxicity, genotoxicity, and sensitization testing- Surface characteristics, including roughness, wettability, and residual stresses- Sterilization compatibility and stability- Marking, packaging, and labeling requirementsThe standard also includes detailed test methods and acceptance criteria for evaluating the specified properties of Y-TZP ceramic materials.### Compliance and Regulatory ConsiderationsCompliance with BS EN ISO 13356:2015 is essential for medical device manufacturers seeking to market their Y-TZP ceramic implants in the European Union and other markets that recognize the standard. The standard is harmonized with the EU Medical Devices Regulation (MDR), ensuring that certified products meet the essential safety and performance requirements.By adhering to the requirements of BS EN ISO 13356:2015, manufacturers can demonstrate the quality, safety, and effectiveness of their Y-TZP ceramic implants, facilitating regulatory approval and market access. This standard is a critical tool for ensuring patient safety and positive clinical outcomes in the healthcare industry.### Obtain the StandardBS EN ISO 13356:2015 is available for purchase in both digital (PDF) and hardcopy formats. To ensure compliance and access the latest technical specifications, you can download the PDF or order the hardcopy version from the BSI Group website.