In order to obtain CB certificate in safety standards, with or without the intervention of a Notified Body, electromagnetic compatibility and electrical safety tests must always be carried out to guarantee the safety of the product. CERE laboratories provide you with all the technical resources, knowledge, experience, and accreditation to carry out this work in accordance with the applicable standards:
UNE-EN-IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
UNE-EN-IEC 60601-1-6 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability.
Collateral application standards 62304 (Software), 60601-1-8 (Alarms), 60601-1-11 (Domestic environment) and 60601-1-12 (Emergency environment) according to the intended use and operation of the equipment.
Specific application standards 60601-2-XX depending on the intended use and operation of the equipment.
In Vitro Devices (IVD):
UNE-EN-IEC 61010-1 Safety requirements for electrical equipment for measurement, control and laboratory use — Part 1: General requirements
Specific application standards 61010-2-XX according to the intended use and operation of the equipment.