Avoid Redesigns by Keeping the Standards in Mind
As a former Certification Engineer for major accredited testing laboratories, such as, UL, Intertek/ETL and contractor for MET and TUV America, 90% of the devices that I have assessed had some form of failures.
Some common failures included,
- "Critical components"
- Labeling and markings
- Protective earthing
- Creepage distance and air clearance
- Patient isolation
- Radiated emission
- Hi-pot test
- Leakage currents and many others
Design with #IEC60601 series standards in mind.
Include in your design requirements and design inputs specifics of IEC 60601 series standards requirements. But, before you can get to this point, you must have a thorough understanding of the requirements.
Avoid costly and timely mistakes.
We can provide design inputs based on the applicable IEC 60601 series standards then perform pre-compliance review before you submit your #medtech devices for formal certification. We can also coordinate the entire certification process with your chosen testing laboratory.
Simply complete the short quote form below: