Active implantable medical devices (AIMD)

What are AIMDs?

Active implantable medical devices (AIMDs) are medical devices that are implanted in the human body either permanently or temporarily. The require their own power source, perform diagnostic or therapeutic functions and are subject to the strictest safety and reliability requirements. Typical AIMDs:

  • Pacemakers / Implantable cardioverter-defibrillators (ICDs)
  • Neurostimulators
  • Cochlear implants
  • Infusion pumps (e.g., insulin pumps)

AIMDs belong to the highest risk class (class III) according to Regulation (EU) 2017/745 on medical devices (MDR) and must undergo particularly stringent testing, documentation and approval procedures.                                                                                                  

Standards and regulations: ISO 14708 & MDR

ISO 14708 (replacing EN 45502) defines requirements for product safety, electromagnetic compatibility (EMC), environmental influences and labelling. Relevant parts of ISO 14708 are:  

  • ISO 14708-1: General requirements for safety, marking and for information to be provided by the manufacturer
  • ISO 14708-2: Cardiac pacemakers
  • ISO 14708-3: Implantable neurostimulators
  • ISO 14708-4: Implantable infusion pump systems
  • ISO 14708-5: Circulatory support devices
  • ISO 14708-6: Implantable defibrillators
  • ISO 14708-7: Cochlear implants 

For CE conformity assessment (known as „CE certification”), manufacturers must comply with the new Medical Device Regulation (MDR) EU 2017/745. As part of the European Commission's ongoing harmonisation mandate M/757 to the European standardisation organisations CEN and CENELEC, the ISO 14708 series is to be fully harmonised by 27 May 2028.

Specific requirements for AIMDs 

Active implants must always operate safely and reliably under various influences, such as:

  • No interference during MRI or ultrasound examinations (medical diagnostics)
  • No impairment from electrosurgical instruments
  • Safe functionality even after an external defibrillation shock
  • Electromagnetic fields    

Our service portfolio for AIMDs and related non-implantable components

As an accredited laboratory according to DIN EN ISO/IEC 17025 and a recognized CB test lab under the IECEE CB scheme, SGS offers comprehensive testing and certification services for both implantable and non-implantable components of active implantable medical devices (AIMDs).

Implantable components:

  • Testing according to ISO 14708-1, ISO 14708-2, ISO 14708-3, ISO 14708-4, ISO 14708-6 and ISO 14708-7
  • Safety testing according to DIN EN IEC 60601 / DIN EN IEC 80601, including country-specific deviations (USA, Canada, Japan, Korea)
  • Test programmes for medical devices for home use (IEC 60601-1-11)
  • EMC testing according to IEC 60601-1-2 and ISO 14117
  • Software validation (IEC 62304)
  • Review of risk management files (ISO 14971)
  • Battery testing (IEC 62133-2)
  • Development-related tests and design analyses

Non-implantable components (remote controls, programming units, chargers, …):

  • Testing according to relevant standards such as IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 14971 and IEC 62133-2 to ensure safety, EMC compliance, software quality, risk management and battery safety
  • Development-related tests and design analyses
  • International certifications such as CB, NRTL or INMETRO

Additional testing within the SGS network:

  • Functional safety & cybersecurity
  • Environmental simulation tests (shock testing according to IEC 60068-2-27, vibration testing according to IEC 60068-2-64, climatic storage according to IEC 60068-2-14)
  • Biocompatibility testing according to ISO 10993
  • Particle analyses according to USP 788 (AAMI TIR42)

Your benefits with SGS

  • Global leader in testing, inspection and certification
  • International expertise in market access and regulatory approval
  • Comprehensive support from a single source: from product idea to market launch

Contact

Armin Hudetz
t: +49 89 78 74 75-133
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Customer Service Team
t: +49 89 78 74 75-222
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