YY 0299-2008 (English Version) PDF

Scope: This standard specifies the definition, requirements, test methods, inspection rules, packaging, marking, transportation and storage of medical ultrasonic lotus root mixture. This standard applies to medical ultrasonic lotus root mixture products (hereinafter referred to as products), including those manufactured and sold by enterprises as commodities, as well as those produced by medical units for their own use. This product is used as a sound-transparent medium between the probe (or treatment head) and the skin during ultrasound diagnosis and treatment operations. This standard can be used as a reference for medical ultrasonic coupling pads. This standard does not apply to products that are in direct contact with tissue incisions during intraoperative ultrasound operations. For products with other characteristics (such as sterility, sterilization), manufacturers should supplement their corresponding requirements.

YY 0299-2008 Referenced Document

GB 7916-1987 Hygienic Standard for cosmetics
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 16886.5-2003 Biological evaluation of medical devices--Part 5: Test for in vitro cytotoxicity
GB/T 191-2008 Packaging.Pictorial marking for handling of goods