This standard specifies the terms and definitions, product classification, requirements and test methods for ophthalmic lens ultrasonic extraction and vitrectomy equipment. This standard applies to equipment that uses ultrasonic energy to perform ophthalmic lens removal surgeries. Such equipment generally also has the function of vitrectomy.
YY 0766-2009 Referenced Document
GB 9706.1 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance*, 2020-04-09 Update
GB 9706.15 Medical electrical equipment.Part 1:General requirements for safety.1.Collateral standard:Safety requirements for medical electrical systems
ISO 15752:2000 Ophthalmic instruments - Endoilluminators - Fundamental requirements and test methods for optical radiation safety
YY/T 0644-2008 Ultrasonics-surgical systems.Measurement and declaration of the basic output characteristics
YY 0766-2009 history
2009YY 0766-2009 Lens ultrasonic removal and vitrectomy devices for ophthalmic surgery