Implantable Medical Device Testing

Navigate Evolving IEC 61000 Standards for Active Implantable Medical Devices (AIMD)

To ensure patient safety, personal protection, and continuous reliable operation, you must verify your implanted device's compliance to Safety, EMC, and Product-Specific Standards related to its purpose and function We test a wide range of equipment, including ISO 14708 series for Implantable Devices:

  • Cochlear Implants
  • Implantable Active Monitoring Devices
  • Implantable Cardiac Pacemakers
  • Implantable Defibrillators
  • Implantable Infusion Pumps
  • Implantable Stimulators

The electromagnetic environments experienced by active implantable medical devices (AIMD) vary from those encountered by common types of medical electrical equipment. Partner with lntertek to ensure compliance to these basic EMC standards:

IEC 61000-4-3RF Radiated Immunity
IEC 61000-4-8Radiated Magnetic Immunity
IEC 61000-4-20Radiated Emissions

 

*The Intertek legal entities that provide medical device management system certification services (including ISO 13485 and MDSAP) and Notified Body services (MDR 2017/745 and MDD 93/42/EEC) do not provide any consulting services. Clients who have used other Intertek legal entities’ consulting services are not eligible to receive management system certification services or Notified Body services from Intertek.

 
 
 
 
 

Need help or have a question?

+1 800 967 5352
UK/EIRE:
+44 116 296 1620
S. AMER:
+55 11 2842 0444
APAC:
+86 400 886 9926
Benelux:
+31 88 126 8888
Germany
+49 711 27311 152
UAE
+971 4 317 8777
India
+91 11 4159 5408
Hong Kong:
+852 2173 8888