Implantable Medical Devices Testing Solutions
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 | RF Radiated Immunity |
| IEC 61000-4-8 | Radiated Magnetic Immunity |
| IEC 61000-4-20 | Radiated Emissions |
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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.
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
- Evolution of the Home Healthcare Market and Medical Device Compliance
White Paper | Webinar Recording - Ventilator Production: Introductory Guide to Regulatory Requirements
- Critical Care Medical Devices: First-In-Queue Priority
- Medical Robots Fact Sheet
- Product Listing & Marking Strategies White Paper
- IEC 60601-1-2 Edition 4 White Paper
- Updated FCC Approval Process Webinar
- Extractables and Leachables Studies Fact Sheet
- Five Steps to Medical Device Commercialization in the United States White Paper
- Making Green Profitable: Using IEC 60601-1-9 as a Competitive Advantage White Paper
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