Certification
Standards, Tests & Certification for LifeUltra:
FDA Cleared for LifeUltra: K250168
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EN 61010-1: 2010 / AM1:2016 / COR1:2019"
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61010-1 Edition 3.1 2017-01 CONSOLIDATED VERSION
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IEC 61010-2-040:2021EN
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IEC 61326-1: 2021
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IEC 61326-1 Edition 3.0 2020-10
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EN 13060:2014+A1:2018
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AAMI ANSI ST 55 : 2016
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AAMI ANSI ST55:2016/(R)2023
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IEC 62304:2006
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ASME BPVC Sec VIII, Div I: 2019
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CFR 47, FCC Part 15B (using ANSI C63.4: 2014)
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ISO 62366-1
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IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION
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ISO 17665:2024
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ISO 17665 First edition 2024-03
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IEC 60601-4-2
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IEC 60601-1-2 ed 4.1
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IEC TR 60601-4-2 Edition 1.0 2016-05
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IEC 60601-1-2:2014+AMD1:2020 CONSOLIDATED VERSION edition 4.1
Providing safety and security with every medical device we produce
Standards, Tests & Certification for LifeRay:
FDA Cleared for LifeRay: K241305
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IEC 60601-1 Safety requirements for Medical Electrical Systems
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IEC 60601-1-2 Electromagnetic disturbances for Medical Electrical Systems
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IEC 60601-1-3 Radiation protection in Diagnostic X -ray Equipment
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IEC 60601-2-28 X-ray tube assemblies for medical diagnosis
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IEC 60601-2-65 Dental intra-oral X -ray Equipment
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IEC 62304 ed 1.1 Software life cycle processes for Medical Devices
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IEC 62366-1 ed 1.0 Usability Engineering Application Medical Devices
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21CFR sub chapter-J FDA Radiological Health Regulation
