YY 0299-2008 in English

本标准代替YY 0299-1998《医用超声耦合剂》。
本标准规定了医用超声耦合剂的定义、要求、试验方法、检验规则及其包装、标志、运输和贮存。
本标准适用于医用超声耦合剂产品（以下简称产品），包括企业作为商品制造、销售的，也包括医疗单位自制自用的。该产品在超声诊断和治疗操作中用作探头（或治疗头）与皮肤之间的透声媒质。
本标准可供医用超声耦合垫参考采用。
本标准不适用于术中超声操作中与组织切口直接接触的产品。对具有其他特性（如无菌、灭菌）的产品，制造商应补充其相应要求。
本标准与YY 0299-1998相比主要变化如下：
———将卫生要求改为生物学评价，并依据与皮肤短时间接触的特点，从GB/T 16886《医疗器械生物学评价》标准中选择试验方法；
———在采用脉冲透射插入取代法的声衰减系数测量中，规定就水中声衰减进行修正；
———修改了检验规则。

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.