Safety

Sentinel and C8000 Series Medical and Electrical Safety Test Systems

Chroma’s Sentinel Systems are fully customized automated test solutions designed specifically for medical device electronics, including R&D and production testing, in order to meet global compliance requirements.

The purpose of safety testing medical electronic equipment is to be sure that a device is safe from electrical hazards to the patient and caregivers. There are a number of UL, European and Canadian standards that serve as the ruling body on how medical products will be tested, one in particular, IEC60601 (the International Electrical Safety Standard for medical electronic equipment) is experiencing “global harmonization,” meaning it has been accepted and implemented around the world. The IEC60601 standard is mainly intended for product development where safety considerations must be taken into account early in the design phase of a product, however much of it is applied to production line testing since it is the only way for a manufacturer to be sure they are shipping safe product.

  • System Type

  • Product

  • System Name
  • Features
  • Medical Products with or no patient contact
  • Medical Products with 1 B Type Patient Leakage and multiple Leakage points tested manually
  • Plug in Appliances UL/CSA/ IEC -EN 60335
  • Medical Products with F-Type Leakage and up to 16 patient contact points
  • Computer/ITE Equipment UL/CSA/IEC-UN 60950
  • Laboratory Test and Measurement Equipment and Process Control UL/CSA/IEC-EN 61010
  • Motors and Wound Cmponents
  • Testing for UL/CSA/IEC-EN 60601
  • Automotive
  • UPS, Relocatable Power Taps and multi Plug Equipement
  • Functional Testing
  • Expandable Measurment Functions LCR Meter,AC/DC Source and Loads Power Analyzer, DMM
  • Testing for UL/CSA/IEC-EN 60601 & 60601-2-XX
  • Testing Capability
  • Data Logging Software
  • Ground Bond
  • AC Hipot up to 5kVac/DC up to 6kVdc
  • AC Hipot up to 5kVac/DC up to 6kVdc Multipoint
  • Insulation Resistance
  • Patient Leakage
  • Earth Line Leakage
  • Enclosure Leakage
  • Enclosure Leakage up to 4 points
  • Patient Auxiliary Leakage Multiple Points up to 16
  • Programmable AC Source
  • F-Type Leakage (110% Mains on Applied Part) - up to 16 points
  • Rack Integration
  • Electrical Safety

  • 8900 Electrical Safety Test System
  • C8900 Automated Safety Test System
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