YY 0845-2011 (English Version) PDF

Scope: This standard specifies the terms and definitions, product composition, basic parameters, technical requirements, test methods and inspection rules of semiconductor laser photodynamic therapy machines. This standard applies to semiconductor laser photodynamic therapy machines (hereinafter referred to as therapy machines), which use lasers of specific wavelengths and photosensitizers to produce photochemical effects for clinical units to perform photodynamic therapy.

YY 0845-2011 Referenced Document

GB 7247.1 Safety of laser products.Part 1:Equipment classification and requirements*， 2012-12-31 Update
GB 9706.1 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance*， 2020-04-09 Update
GB 9706.19-2000 Medical electrical equipment-Part 2:Particular requirements for the safety of endoscopic equipment
GB 9706.20 Medical electrical equipment Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment
GB/T 14710-2009 Enviromental requirement and test methods for medical electrical equipment
GB/T 17736-1999 Testing method of main parameters for laser protective eyewear
GB/T 191 Packaging.Pictorial marking for handling of goods
YY 91057-1999 General specifications for medical foot switch
YY/T 0758-2009 General requirements for therapeutic laster fiber

2011 YY 0845-2011 Laser therapeutic equipment.Diode laser equipment for photodynamic therapy