SANYO Leads the Way on Medical Device Certification
Product News May 16, 2011
SANYO underlines a strong commitment to product design, quality and safety by becoming one of the first major international companies to gain Medical Device certification to European Council directives 93/42/EEC and 2007/47/EC across a wide range of refrigeration and incubation products.
Customers looking for blood bank refrigerators, plasma and ultra-low temperature freezers or CO2 incubators to preserve or cultivate cells, tissues and blood components for human use can be sure that SANYO products meet current and future regulatory requirements.
Medical Device certification aims to protect the safety of patients and users, ensuring that such products are designed and manufactured to the very highest quality standards.
Based on their intended use for storing blood, European Commission guidelines issued in 2010 stated that blood bank refrigerators and plasma freezers should be medical devices.
The need for incubators and refrigeration units for cultivating or storing cells and tissues for human use is set to expand. As rapidly developing techniques for stem cell therapy and regenerative medicine may lead to wider requirements for Medical Device certification, SANYO has taken the initiative so that customers may buy certified products in advance of any possible changes in the regulatory landscape.
The first SANYO products to be certified as Medical Devices during 2011 will include the MCO-19AIC CO2 incubator with rapid hydrogen peroxide vapour decontamination option, the MBR-305GR blood bank refrigerator and the MDF-U74V ultra-low temperature freezer.
Two brand new ultra-low freezer models will also gain certification: MDF-U55V, the latest V.I.P. freezer, and MDF-U700VX which offers an innovative dual-cooling system for the highest level of sample security.
SANYO was awarded certification to manufacture blood bank refrigerators, freezers and incubators as Class IIa Medical Devices by TÜV-Süd in 2010. At the same time, SANYO’s quality systems were updated to the latest ISO9001 and ISO13485 standards.