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 61000-4-3: Radiated Radio-Frequency (RF) Electromagnetic Field Immunity Testing
- Evaluates device performance when exposed to radiated RF fields, such as those from mobile phones or radio transmitters.
- IEC 61000-4-8: Power Frequency Magnetic Field Immunity Testing
- Examines how devices withstand low-frequency magnetic fields, which can be generated by nearby electrical equipment or power lines.
- IEC 61000-4-20: Emission and immunity testing in transverse electromagnetic (TEM) waveguides and reverberation chambers
- Addresses the testing of radiated, radio-frequency electromagnetic fields in a controlled environment using reverberation chambers
Webinar: Regulatory Requirements for Active Implantable Medical Devices
Patient safety and device reliability are paramount when it comes to Implantable Medical Devices. View our free on-demand webinar on the regulatory requirements for active implantable medical devices.
Webinar: EMC & Wireless Requirements for Active Implantable Medical Devices
Compliance with EMC and Wireless regulatory requirements are an essential aspect of bringing Active Implantable medical devices to market. Learn how from our experts with this free on-demand webinar.
White Paper: Active Implantable Medical Devices Evaluation & Testing Requirements
The FDA and regulators around the world require that products comply with all applicable product standards. Our white paper can help navigate through all applicable standards and how to best approach them.
News: Accreditation for End-to-End Evaluation of Implantable and Non-Implantable Medical Devices
Intertek is the first independent lab in North America to gain accreditation for end-to-end evaluation of active implantable and non-implantable medical devices.
Knowledge Center
Download the latest information from our medical device compliance experts
Creation of IEC 60601-1 4th Edition
IEC 60601-1-2 Ed. 4.1 Overview of Requirements
Medical OEM Wireless Coexistence Testing
Artificial Intelligence (AI) and Machine Learning (ML) in Medical Devices
Biocompatibility Risk Assessment and Evaluation Plans
For more expert papers, recordings, and presentations, visit our Medical Resources hub.
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*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.
