Qualification & Certification Medical Technology

Reliable Products through Simulation, Tests and Analyses

Accredited in compliance with DIN EN ISO 17025

Calculation and simulation

  • Optimisation and validation of the vibration behavior through MBS and FEM
  • Component and system optimisation
  • Static and dynamic fatigue strength testing for metals, synthetic materials and adhesive bonds
  • Method development for customer-specific tasks

Certification of medical technology systems

  • Vibration tests and function tests
  • Performing x-rays for functional tests possible
  • Single-source process performance in compliance with OSHPD * requirements
    • Consulting and test plan drafting
    • Acceptance testing and preparation of application documents
    • Attainment of the Special Seismic Certification Preapproval

* OSHPD
California's Office of Statewide Health Planning and Development (OSHPD) is the leader in collecting data and disseminating information about California's healthcare infrastructure. OSHPD promotes an equitably distributed healthcare workforce, and publishes valuable information about healthcare outcomes. OSHPD also monitors the construction, renovation, and seismic safety of hospitals and skilled nursing facilities and provides loan insurance to assist the capital needs of California's not-for-profit healthcare facilities.

 

Fatigue strength testing

  • Determination of static material key data
  • Determination of the fatigue strength on material samples and components in combination with environmental conditions
  • Development of test concepts for customer-specific tasks

Climate tests

  • Function testing under extreme environmental conditions: high / low temperatures, high humidity, changes in air  ressure, and combined conditions
  • Corrosion and aging tests

Material and failure analyses

  • Systematic failure analysis in compliance with VDI guideline 3822
  • Determination of damage mechanisms
  • Deduction of damage causes
  • Definition of remedial measures
  • Consulting on failure prevention measures
  • Microstructure analyses
  • Material characterisation
  • Non-destructive component testing

IABG is the only company in Europe listed by the OSHPD and is thus authorised to perform certification processes.

Here you can find our services for

Medical Technology Sector

 

 

Certification in accredited test laboratory for vibration testing

as per DIN EN ISO 17025 and OSHPD

Special, often country-specific, seismic safety regulations apply for equipment in the energy and medical technology sectors.

In particular, the US state of California has its own test standards and acceptance procedures. These are monitored by special authorities who then certify the qualification of the equipment accordingly. This certification process includes the planning and execution of tests by a test laboratory accredited in compliance with ISO 17025 under the supervision of a California Licensed Structural Engineer and certification by the Office of Statewide Health Planning & Development (OSHPD).
Certification process for medical technology equipment

Certification process for medical technology equipment

  •     Single-source process implementation in compliance with requirements of the OSHPD
  •     Laboratory accredited in compliance with ISO 17025 to perform vibration tests and function tests
  •     X-radiation applicable for function checks
  •     Consulting and test plan drafting
  •     Acceptance testing and creation of application documents in collaboration with recognised specialists
  •     Attainment of OSHPD Special Seismic Certification Preapproval