Bioconnect Certification and Workmanship Standards
Bioconnect is committed to meeting or exceeding these demanding quality standards to assure that all requirements for your custom application and those for all standard Bioconnect products are met.
- FDA Registered Facility
- FDA 510K Registration (K010809)
- FDA cGMP Compliant
- California FDA
- ANSI/AAMI EC-53-1995 Cable and Lead Standards
- AAMI (EC-13, EC-53, EC-38)
- Quality Assurance and Inspection certified to MIL-I-45208
- Calibration Standards traceable to NIST
- IPC/EIA J-STD-001 and IPC/WHMA-A-620 Standards
- IEC 601 Standards
- DIN 42-802 Standards
- Internal company quality workmanship standards
- All products are latex-free and surface materials chosen for biocompatibility.