Recently, according to the proposal of the State Drug Administration and jointly drafted by Hubei Institute of medical device quality supervision and inspection, the \"medical professional standard of the people\'s Republic of China YY / T 1676 ultrasonic endoscope\" was released, which marks a new chapter in the independent development of high-end medical devices in China.

　　超声内窥镜作为介入领域的高端医疗设备，工艺复杂度高、技能完成难度大。目前我国的超声内窥镜设备依赖进口，其昂扬的给医院及病人带来较大的经济压力，不利于超声内窥镜诊疗技能在国内的推广普及。开立医疗作为国内超声和内窥镜职业的领军企业，在该领域持续投入立异研制,为推动超声内窥镜国产化做出了应有贡献。
            

　　As a high-end medical equipment in the field of intervention, ultrasonic endoscope has high process complexity and difficult skill completion. At present, the ultrasonic endoscopy equipment in China relies on imports, and its high price brings great economic pressure to hospitals and patients, which is not conducive to the popularization of the ultrasonic endoscopy diagnosis and treatment skills in China. As a leading enterprise in ultrasound and endoscopy in China, Kaifa medical has continuously invested in innovation and development in this field, which has made due contribution to promoting localization of ultrasound endoscopes.

　　国产首台电子环扫超声内镜EG-UR5

　　The first domestic electronic ring scanning endoscopic eg-ur5

　　2019年，开立医疗自主研制的电子环扫超声内窥镜EG-UR5取得欧盟CE认证，技能参数抵达同类产品国际水平，标志着开立医疗成为继奥林巴斯、富士、宾得日本三大内窥镜企业之后，全球第四家、国内首家具有超声内窥镜产品研制和生产才能的医疗器械企业。本次开立医疗也作为国产医疗器械企业的代表参加了我国超声内窥镜职业标准的拟定。

　　In 2019, the electronic ring scanning ultrasonic endoscope eg-ur5 independently developed by Kaifa Medical Co., Ltd. obtained EU CE certification, and its technical parameters reached the international advanced level of similar products, marking that Kaifa Medical Co., Ltd. has become the fourth medical device enterprise in the world and the first one in China with the ability to develop and produce ultrasonic endoscope products, following the three major endoscope enterprises of Olympus, Fuji and Pentax Japan. As a representative of domestic medical device enterprises, the opening medical service also participated in the formulation of occupational standards for ultrasound endoscopy in China.

　　医用电子内窥镜可以伸入体腔内部近距离观测，获取黏膜表面微结构和微血管形状信息，是消化道、呼吸道、耳鼻喉、泌尿系统等疾病特别是恶性肿瘤前期确诊、监测和微创的重要办法。可是依据光学成像原理的惯例电子内窥镜检查受照明光在安排中高强度散射的影响，成像深度仅为数百微米，使其临床运用遭到必定限制。超声内窥镜将超声成像与光学成像进行系统集成，既能调查黏膜表面形状，又能获取各断层的安排学信息，了惯例电子内窥镜短缺深度方向分辩才能的问题。一同，超声内窥镜经过体内勘探的办法使声回路大幅缩短，避免了其他脏器对超声信号的干扰，从而可运用相较于体表超声成像更高的频率规划勘探，显著进步超声图画的纵向分辩力。

　　Medical electronic endoscope can be extended into the body cavity for close observation to obtain the information of mucosal surface microstructure and microvascular shape. It is an important method for the diagnosis, monitoring and minimally invasive treatment of digestive tract, respiratory tract, otolaryngology, urinary system and other diseases, especially for the early stage of malignant tumors. However, according to the conventional principle of optical imaging, electronic endoscopy is affected by the high-intensity scattering of light in the arrangement, and the imaging depth is only hundreds of microns, which limits its clinical application. Ultrasonic endoscope integrates ultrasonic imaging and optical imaging system, which can not only investigate the shape of mucous membrane surface, but also obtain the arrangement information of each fault, which solves the problem that the conventional electronic endoscope lacks the ability of depth direction discrimination. In the same time, the method of in vivo exploration of the ultrasonic endoscope greatly shortens the acoustic circuit and avoids the interference of other organs on the ultrasonic signal. Therefore, the higher frequency planning exploration compared with the surface ultrasonic imaging can be used to significantly improve the vertical resolution of the ultrasonic image.

　　伴随着近40年的技能展开，超声内窥镜在协助医师判别病灶规划、浸润深度、病变性质方面的价值日益突显，在确诊和胆、胰疾病的临床运用中更是发挥了其他医学影像办法难以替代的作用，极大扩展了内窥镜的临床使用规划。

　　With the development of skills in the past 40 years, the value of ultrasound endoscopy in helping doctors to identify the focus planning, depth of invasion and nature of lesions is increasingly prominent. It also plays an irreplaceable role in the clinical application of other medical imaging methods in the diagnosis and treatment of biliary and pancreatic diseases, greatly expanding the clinical application planning of endoscopy.

　　此次发布的《YY/T 1676-2020超声内窥镜》职业标准对超声内窥镜专用的性能目标、目标、检测办法等进行了界说和标准，使厂家、检测组织、监管组织在制造、检测、阅览过程中有章可循。一同，《YY/T 1676-2020超声内窥镜》职业标准的发布，将加速超声内窥镜在我国的临床推广和普及，成为我国相关临床学科展开和器械制造的重要推动力。

　　The occupational standard of YY / T 1676-2020 ultrasonic endoscope issued this time defined and standardized the special performance objectives, safety objectives and testing methods of ultrasonic endoscope, so that manufacturers, testing organizations and regulatory organizations can follow rules in the process of manufacturing, testing and reading. Together, the release of occupational standard YY / T 1676-2020 ultrasound endoscopy will accelerate the clinical promotion and popularization of ultrasound endoscopy in China, and become an important driving force for the development of related clinical disciplines and equipment manufacturing in China.