Glossary Term
ASTM Standards (e.g., ASTM F1980)
Definition
ASTM Standards refer to a comprehensive set of technical standards developed by ASTM International (formerly the American Society for Testing and Materials). These standards provide guidelines for testing, design, and performance criteria across various industries, including MedTech. In the medical device sector, ASTM Standards address material properties, biocompatibility, sterilization methods, and mechanical testing of devices and their components.
Relevance to the MedTech Industry
ASTM Standards play a critical role in ensuring the safety, reliability, and quality of medical devices. By providing standardized methodologies for testing and evaluation, they enable manufacturers to validate material performance, ensure compliance with regulatory requirements, and foster innovation. The standards also facilitate international trade by harmonizing product specifications and testing protocols across global markets.
Additional Information & Related Terms
Biocompatibility/Biocompatibility Standards Ensure materials meet safety criteria for use in medical devices.
ISO 10993 A standard for biological evaluation of medical device materials, often used alongside ASTM Standards.
Sterilization Validation ASTM Standards, such as ASTM F1980, help validate sterilization processes.
Mechanical Testing Covers strength, durability, and other material properties critical for device performance.