This standard specifies the terms and definitions, requirements, test methods, inspection rules and markings, packaging, transportation and storage of high potential therapy equipment. This standard applies to high-potential therapy equipment (hereinafter referred to as equipment) specified in 3.1.
YY 0649-2008 Referenced Document
GB 9706.1-2007 Medical electrical equipment.Part 1:General requirements for safety
GB/T 14710 Enviromental requirement and test methods for medical electrical equipment*, 2009-11-15 Update
GB/T 191 Packaging.Pictorial marking for handling of goods
YY 0505 Medical electrical equipment.Part 1-2:General requirements for safety.Collateral standard:Electromagnetic compatibility.Requirements and tests*, 2012-12-17 Update