AAMI Medical Device Testing Requirements

Management, development and safe/effective use of health technology.

If your company is developing or manufactures a medical device, it maybe required to have testing according to AAMI Consensus Standards. The Association for the Advancement of Medical Instrumentation® (AAMI) is a nonprofit organization that is focused on the management and development of safe health technology. AAMI is the primary source of both national and international consensus standards for the medical device industry. AAMI provides support and guidance for healthcare professionals, and standards intended to enhance safety, efficacy, and proper management of medical devices and health technologies.

AAMI leads global collaboration in the development, management, and use of safe and effective health technology including the following:

  • To improve patient care by advancing the safety and effectiveness of health technology.
  • Information sharing.
  • Ethical and professional standards.
  • Encouraging collaborations.
  • Quality.

Contract Laboratory has helped many medical device researchers and manufacturers with their AAMI testing including the following projects:

  1. Contract Laboratory needed for ANSI / AAMI testing of single lead hardwired ECG cable 19 long terminated with a snap-on connector as per ANSI / AAMI EC53 ECG Trunk Cables And Patient Leadwires.
  2. Contract Medical Laboratory needed for testing Gel like material as per the following list: following tests will be performed on the gel-like material with density 0.99-1.01 cm3, pH=6.00-7.20, viscosity=150.000-185.000cP.a – Sound Velocity. – Acoustic Impedance. – Sound Attenuation – Ultrasound and Doppler compatibility/performance ECG gel pad test according to e-IEC/CD 80601-2-86 or ANSI/AAMI EC12:2000 (R2020)f- Change of light intensity and surface temperature when used in treatments with IPL (Diode Laser)
  3. Contract Medical Device Laboratory needed for controlled environment (atmospheric pressure, temperature, humidity, backpressure, etc) volumetric accuracy testing for ambulatory infusion pump as per AAMI TIR101 (Fluid Delivery Performance Testing For Infusion Pumps) pump has 2 pieces, 5×3 / 3×1 can supply as many as needed depending on start date
  4. Medical Device Laboratory needed for AAMI testing of disposable pressure transducer according to AAMI BP22:1994(R)2016. Blood Pressure Transducers.

Does your medical device developer or manufacturer need help with AAMI testing of a medical device such as a new medical technology or medical equipment? Contract Laboratory can help. Submit Laboratory Requests for AAMI Testing.