This standard specifies the terms and definitions, requirements, test methods, markings, labels, instructions for use, packaging, transportation and storage of confocal laser scanners. This standard applies to in vitro diagnostic medical devices, scanners based on the laser confocal principle using a planar substrate as a carrier.
YY/T 1154-2009 Referenced Document
GB 4793.1 Safety requirements for electrical equipment for measurement,control,and laboratory use.Part 1:General requirements
GB/T 14710 Enviromental requirement and test methods for medical electrical equipment
GB/T 191 Packaging.Pictorial marking for handling of goods
YY 0466 Medical devices-Symbols to be used with medical device labels,labelling and information to be supplied
YY 0648 Safety requirments for electrical equipment for measurement,control and laboratory use.Part 2-101:Particular requirments for in vitro diagnostic(IVD)medical equipment