Project Description

CE Marking

The CE marking (Conformité Européenne or European Conformity), formerly known as CE marking, is the mandatory European marking for certain products. Since its creation in 1989, it has determined a common conformity standard, with a single logo and a comprehensive approach to conformity assessment. 

To be sold and marketed in the EU (European Union), many products must bear the CE marking, which proves that the manufacturer has assessed the product and that it complies with the safety, health and environmental protection requirements of the EU. 

The CE marking was born and is based on Directive 93/68/EEC, which diverges into other specific Directives and Regulations depending on the product category. This Directive was established by the European Community with the aim of transferring the responsibility by means of self-declaration by the manufacturer that his product complies with the relevant essential legal and technical (not quality) requirements in terms of safety, health and environmental protection defined by the Directives and/or Regulations of application of the Member States of the European Union. 

In order to obtain CE marking, 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:

Medical Device:

UNE-EN-IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances

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 61326-1 Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 1: General requirements

UNE-EN-IEC 61326-2-6 Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment

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.