• The internationally recognized AAMI Collection provides key standards and best practices for the global healthcare industry. AAMI Standards are designed to increase the safety, performance and reliability of medical devices and technologies. 

    They cover critical areas such as biocompatibility, packaging, labelling and infection control (e.g. for protective clothing). Factors such as design, manufacturing processes, tests and continuous monitoring ensure the highest quality standards.

    AAMI Standards are indispensable for clinics, manufacturers and regulatory authorities worldwide and support reliable healthcare.

  • The AAMI Collection is used by various players in the healthcare industry, including:

    • Manufacturers of medical devices: to fulfil necessary safety and performance specifications for medical equipment.
    • Healthcare facilities such as hospitals and clinics: to ensure the safety and effectiveness of the equipment used.
    • Regulatory authorities and organizations such as the FDA: for the testing and approval of medical devices.

    AAMI Standards have the objective of improving healthcare:

    • Patients benefit from the safety and effectiveness of tested medical devices.
    • Healthcare providers such as doctors, nurses and technicians can guarantee safety standards and reliability in the operability of the devices.
    • Medical research institutions are supported in the development of new and innovative technologies.

  • AAMI (Association for the Advancement of Medical Instrumentation) was founded in 1967 and is a nonprofit US organization for the development of safety specifications, standards and guidelines for healthcare technology that are used worldwide in the healthcare industry. 

    The AAMI Collection is developed by a network of technical committees, industry representatives, regulatory authorities and academic and research institutions. Experts from the healthcare industry, manufacturing and science work together to ensure well-founded standards that meet legal requirements and promote technological progress.