SANYO has gained Medical Device certification to European Council directives 93/42/EEC and 2007/47/EC across a wide range of refrigeration and incubation products, such as blood bank refrigerators.
Medical Device certification is aimed at protecting the safety of patients and users, ensuring such products are designed and manufactured to the 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.
According to SANYO, the need for incubators and refrigeration units for cultivating or storing cells and tissues for human use is set to expand.
Observing that techniques for stem cell therapy and regenerative medicine are rapidly developing, Sanyo decided to act early to ensure 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 new ultra-low freezer models will also gain certification: MDF-U55V, the latest VIP freezer, and MDF-U700VX, which offers a 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 TUV-Sud in 2010.
At the same time, Sanyo's quality systems were updated to the latest ISO9001 and ISO13485 standards.
