YY 0299-2016 (English Version) PDF

Scope: This standard specifies the definition, classification, requirements, test methods, inspection rules and packaging, marking, transportation and storage of medical ultrasonic coupling agents. This standard applies to medical ultrasonic coupling agent products (hereinafter referred to as products), including those manufactured and sold by enterprises as commodities, as well as those produced by medical institutions for their own use. This product is used as a sound-transparent medium between the probe, treatment head and human tissue in ultrasound diagnosis and treatment operations.

YY 0299-2016 Referenced Document

GB 27951 General requirements for skin disinfectant*， 2021-10-11 Update
GB/T 14233.2-2005 Test methods for infusion,transfusion,injection equipment for medical use.Part 2:Biological test methods
GB/T 15261 Measurement methods for acoustic properties of ultrasonically tissue-mimicking materials
GB/T 16886.10-2005 Biological evaluation of medical devices.Part 10:Tests for irritation and delayed-type hypersensitivity
GB/T 191 Packaging.Pictorial marking for handling of goods
GB/T 27949 Hygienic requirements for medical items disinfection

YY 0299-2016 Medical ultrasonic couplants was changed to YY/T 0299-2022 Medical ultrasound coupling agent.