This standard specifies the terms and definitions, composition, requirements, test methods, inspection rules, marking, packaging, transportation and storage of plasma surgical equipment. This standard applies to plasma surgical equipment (hereinafter referred to as "equipment") as defined in 3.1. For a multi-functional device, the content specified in this standard only applies to the plasma surgery function of the device, and other functions of the device should comply with the requirements of other relevant standards.
YY/T 1409-2016 Referenced Document
GB 9706.1-2007 Medical electrical equipment.Part 1:General requirements for safety
GB 9706.15-2008 Medical electrical equipment.Part 1:General requirements for safety.1.Collateral standard:Safety requirements for medical electrical systems
GB 9706.4-2009 Medical electrical equipment-Part2-2:Particular requirements for the safety of high frequency surgical equipment
GB/T 14710-2009 Enviromental requirement and test methods for medical electrical equipment
GB/T 16886.1 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process*， 2022-04-15 Update
GB/T 191-2008 Packaging.Pictorial marking for handling of goods
YY 0505-2012 Medical electrical equipment.Part 1-2:General requirements for safety.Collateral standard:Electromagnetic compatibility.Requirements and tests
YY 91057 General specifications for medical foot switch
YY/T 0466.1-2009 Medical devices.Symbols to be used with medical device labels,labelling and information to be supplied.Part 1:General requirements