The MHRA's safety alert has sparked inquiries from healthcare organisations across the UK conducting due diligence on relevant products and seeking clarification on compliance with the standards BS EN 60601-2-52:2010+A1:2015 and BS EN 50637:2017.
At LINET, we've always made your safety our top priority. As a responsible provider of equipment in the field of care, our products undergo rigorous testing to meet and exceed industry regulations and standards, both nationally and internationally. We deeply value the trust you place in us, and this trust underscores our ongoing efforts to uphold the highest standards of quality and safety.
Download LINET's Declaration of Conformity
To further support you and provide assurance, each Declaration of Conformity certificate has been made available to download. What’s more, we have taken the time to highlight the standard compliance within each of these certificates and encourage you to explore and compare certifications from other suppliers as well. Certificates without these essential standards may not guarantee compliance, ultimately putting safety at risk.
Download LINET's Declaration of Conformity for TOM 2
Download LINET's Declaration of Conformity for Eleganza 2
Understanding the Standards
Here's a concise overview:
BS EN 60601-2-52:2010+A1:2015: These regulations were instituted in 2015. Please note that products manufactured before June 2015 may not meet compliance criteria. We encourage customers to perform risk assessments against action points 5, 6, and 7 outlined in the Safety Alert. All LINET products falling under this Regulation and manufactured after June 2015 are fully compliant.
BS EN 50637:2017: This standard exclusively pertains to the 'TOM 2' product within the LINET Group portfolio. The regulations for BS EN 50637:2017 were officially published in November 2017. To verify compliance for the 'TOM 2' product, please reference the model number. Model number 1k4 is deemed compliant, while all other model numbers require a comprehensive risk assessment, as they do not conform to the standard.
Safety is Our Priority
At LINET, we uphold our commitment to ensuring the highest levels of safety, quality, and compliance for all our products. The trust you place in our dedication to product safety and performance is paramount.
Get in Touch
Should you have any additional inquiries or require clarifications, please do not hesitate to contact us. Your partnership is greatly valued, and we eagerly anticipate continuing our collaboration.