top of page
Glossary Term
< Return to Main Navigation

ANSI/AAMI Standards

Definition

ANSI/AAMI Standards refer to a set of guidelines and best practices developed by the American National Standards Institute (ANSI) and the Association for the Advancement of Medical Instrumentation (AAMI). These standards are widely used in the MedTech industry to ensure the safety, efficacy, and quality of medical devices, covering areas such as sterilization, biocompatibility, risk management, and device usability.

Relevance to the MedTech Industry

ANSI/AAMI Standards provide a harmonized framework for medical device manufacturers to meet regulatory requirements and ensure their products perform reliably and safely. By adhering to these standards, manufacturers can streamline product development, demonstrate compliance in regulatory submissions, and enhance patient and user safety. These standards also facilitate global market access by aligning with international norms such as ISO standards​​.

Additional Information & Related Terms

  • ISO 13485 Harmonized with ANSI/AAMI standards for medical device quality management systems

  • Risk Management File (ISO 14971) ANSI/AAMI/ISO 14971 provides a framework for risk management during the product lifecycle

  • Sterilization Validation A core focus of ANSI/AAMI standards, especially for terminally sterilized devices

  • Quality Management System (QMS) Guided by standards like ANSI/AAMI/ISO 13485 to ensure compliance

bottom of page