Dynamic Failure Mode (DFM)
Dynamic Failure Mode (DFM) testing is used together with Accelerated Wear Testing (AWT) to provide a thorough assessment of durability. Since AWT is a “test to success” approach meaning samples are intended to survive the test, DFM testing is a “test to failure” approach which is intended to characterize potential durability-related failure modes.
Typically, a subset of samples that have undergone durability testing to 200 million cycles undergo continued testing until they fail. Alternatively new samples that undergo pre-conditioning (~50 million cycles of AWT) can be used.
The pressure samples experience is progressively increased at predefined time points until failure occurs.
Devices shall be inspected (microscope, photographs, and high-speed video) and functionally evaluated under pulsatile flow at each pressure increment and at least every 50M cycles.
If devices have been tested for 200 million cycles of DFM, with a minimum of 50 million cycles at the maximum pressure condition defined by ISO 5840, then testing may be discontinued. Manufactures are still required to understand the potential failure mode of a device so testing beyond this endpoint is recommended.
- ViVitro Labs Accelerated Wear Tester
- Durability Pressure Data Acquisition System
- High speed video recording system
- Number of Cycles conforming to loading conditions
- Sample pressure waveforms
- Opening and closing kinematics under highspeed video
- Photographic documentation of the appearance of the test sample at defined inspection intervals
- Hydrodynamic performance at defined inspection intervals
- Detailed description of each failure
- Surgical Valves: SAVR, SMVR, SPVR, STVR
- Transcatheter Valves: TAVI / TAVR, TMVI / TMVR, TPVI / TPVRTMVR, TTVR / TTVI and any other transcatheter valve
- Biological, Polymeric, mechanical valves, tissue engineered
- Artificial heart valves prosthesis
- Venous valves
- Valvular conduits
- Any valvular prosthesis
- Any cardiac repair device
Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes
Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques
- Durability Testing (Integrated Durability Assessment)
- Accelerated Wear Testing (AWT)
- Real-Time Wear Testing (RWT)
ViVitro Labs Advantages
Many companies look to academia to handle their testing needs due to the reduced cost. With ViVitro Laboratory Services you gain the following advantages:
Time to Market
We understand how critical your timelines are. Our expertise and experience ensure your schedule is met and our commitments are delivered on time.
ISO 17025 Accredited
For studies used for regulatory approval this is a must. Victoria and Marseille labs accredited by A2LA.
Free Initial Consultations
All of our studies are scoped via no-cost, no obligation, collaborative consultation.
We happily provide Non-Disclosure Agreements for all services, including initial consultation.