Brazil

Product:

In Vitro Diagnostic Medical Device (IVD)

ISO 14971:2019 Medical devices - Application of risk management to medical devices IEC 61326-2-6:2020 RLV Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (I

EMC

IEC 60601-1-2: 2014+AMD1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests CISPR 11:2015 Industrial, scientific a

SAFETY

IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance IEC 61010-2-101:2018 RLV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Partic