The US Food and Drug Administration (FDA) requires that medical devices comply with 60601 standards for electrical safety in healthcare settings
Caregility, a clinical collaboration and communications company focused on providing secure, reliable two-way audio and video communications for any device and clinical workflow, in both inpatient and outpatient settings, announces IEC 60601-1 certification of its UHE telehealth platform.
The U.S. Food and Drug Administration (FDA) requires that medical devices comply with 60601 standards for electrical safety in healthcare settings. Meeting 60601 certification standards, an FDA recognized consensus standard governed by the International Electrotechnical Commission (IEC), affirms that Caregility’s APS systems meet specific requirements regarding the basic safety and essential performance of medical electrical equipment. 60601 certification was validated by SGS North America, Inc., a world leader in inspection, verification, testing and certification.
The announcement comes on the heels of recent news that the Caregility UHE telehealth platform application has been added to Epic’s App Orchard. UHE is a comprehensive, flexible platform that provides video-enabled communications tools to empower clinicians, patients, care coordinators, family members and virtual sitters with an intuitive, nonintrusive and secure interface that can be used within a healthcare facility as well as remote, outpatient settings. The new safety certification demonstrates Caregility’s ongoing commitment to patient and clinician safety.
“This certification reflects our goal to be the healthcare industry’s most reliable and dependable telehealth partner,” said Bin Guan, CTO. “As the world of digital health continues its prolific growth, device dependability and safety will become more important than ever. We take our commitment to safety and reliability very seriously and hope this new certification further bolsters client trust in the Caregility platform.”
60601 testing assesses the electrical safety of medical electrical equipment, including but not limited to power input, capacitor discharge, leakage current, humidity preconditioning, excessive temperatures and impact test assessments.
Source: Company Press Release