New Circulating Light Device with CE Certification

The INT200 LED-based illumination device has recently received CE certification under EU regulations, allowing it to be marketed across the European Union.Overview of CE Certification for Lighting DevicesCE certification ensures that a product complies with EU directives on safety, health, and environmental protection, enabling free circulation within the EU market . For lighting products, CE certification typically covers:Electromagnetic Compatibility (EMC) Directive 2014/30/EU: Ensures the device does not generate excessive electromagnetic interference and can operate reliably in the presence of external electromagnetic disturbances. Relevant standards include EN 55015, EN 61547, and EN 61000-3-2/3 .Low Voltage Directive (LVD) 2014/35/EU: Applies to devices operating between 50–1000V AC or 75–1500V DC, ensuring electrical safety .Photobiological Safety: Testing for blue light hazard weighted radiance (≤ 100 W·m⁻²·sr⁻¹) according to EN 62471 . The certification process involves product analysis, sample testing, technical documentation review, and issuance of a CE conformity certificate. Some products may require annual supervision or factory audits . CE certification must be processed through EU-authorized Notified Bodies to ensure legal validity .Example: INT200 Circulating Light DeviceCerus Corporation's INT200 is a next-generation LED-based illumination device designed for the INTERCEPT Blood System for platelets and plasma. It has recently received CE mark approval under the EU Medical Device Regulation (MDR), allowing it to be marketed throughout the EU and in other regions recognizing the CE mark . Key highlights include:Enhanced user experience and operational benefits through improved physical design and software interface.Compatibility with existing disposable processing sets and pathogen inactivation processes.Regulatory compliance: CE certification confirms adherence to EU safety and performance standards, enabling legal market access.Importance of CE CertificationCE certification for circulating light devices ensures:Legal market access in the EU without repeated testing.Consumer trust and product competitiveness.Compliance with safety and electromagnetic standards, reducing risk of malfunction or interference.Facilitation of trade across EU member states . Manufacturers are responsible for maintaining technical documentation and EU Declaration of Conformity, which must be updated if the product or applicable legislation changes . In summary, the INT200 represents a CE-certified circulating light device that meets EU safety, EMC, and photobiological standards, demonstrating both regulatory compliance and readiness for the European market .