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.

　　超聲內(nèi)窺鏡作為介入領(lǐng)域的高端醫(yī)療設(shè)備，工藝復(fù)雜度高、技能完成難度大。目前我國的超聲內(nèi)窺鏡設(shè)備依賴進(jìn)口，其昂揚(yáng)的價(jià)格給醫(yī)院及病人帶來較大的經(jīng)濟(jì)壓力，不利于超聲內(nèi)窺鏡診療技能在國內(nèi)的推廣普及。開立醫(yī)療作為國內(nèi)超聲和內(nèi)窺鏡職業(yè)的領(lǐng)軍企業(yè)，在該領(lǐng)域持續(xù)投入立異研制,為推動(dòng)超聲內(nèi)窺鏡國產(chǎn)化做出了應(yīng)有貢獻(xiàn)。
            

　　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.

　　國產(chǎn)首臺電子環(huán)掃超聲內(nèi)鏡EG-UR5

　　The first domestic electronic ring scanning endoscopic eg-ur5

　　2019年，開立醫(yī)療自主研制的電子環(huán)掃超聲內(nèi)窺鏡EG-UR5取得歐盟CE認(rèn)證，技能參數(shù)抵達(dá)同類產(chǎn)品國際先進(jìn)水平，標(biāo)志著開立醫(yī)療成為繼奧林巴斯、富士、賓得日本三大內(nèi)窺鏡企業(yè)之后，全球第四家、國內(nèi)首家具有超聲內(nèi)窺鏡產(chǎn)品研制和生產(chǎn)才能的醫(yī)療器械企業(yè)。本次開立醫(yī)療也作為國產(chǎn)醫(yī)療器械企業(yè)的代表參加了我國超聲內(nèi)窺鏡職業(yè)標(biāo)準(zhǔn)的擬定。

　　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.

　　醫(yī)用電子內(nèi)窺鏡可以伸入體腔內(nèi)部近距離觀測，獲取黏膜表面微結(jié)構(gòu)和微血管形狀信息，是消化道、呼吸道、耳鼻喉、泌尿系統(tǒng)等疾病特別是惡性腫瘤前期確診、監(jiān)測和微創(chuàng)治療的重要辦法。可是依據(jù)光學(xué)成像原理的慣例電子內(nèi)窺鏡檢查受照明光在安排中高強(qiáng)度散射的影響，成像深度僅為數(shù)百微米，使其臨床運(yùn)用遭到必定限制。超聲內(nèi)窺鏡將超聲成像與光學(xué)成像進(jìn)行系統(tǒng)集成，既能調(diào)查黏膜表面形狀，又能獲取各斷層的安排學(xué)信息，解決了慣例電子內(nèi)窺鏡短缺深度方向分辯才能的問題。一同，超聲內(nèi)窺鏡經(jīng)過體內(nèi)勘探的辦法使聲回路大幅縮短，避免了其他臟器對超聲信號的干擾，從而可運(yùn)用相較于體表超聲成像更高的頻率規(guī)劃勘探，顯著進(jìn)步超聲圖畫的縱向分辯力。

　　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.

　　伴隨著近40年的技能展開，超聲內(nèi)窺鏡在協(xié)助醫(yī)師判別病灶規(guī)劃、浸潤深度、病變性質(zhì)方面的價(jià)值日益突顯，在確診和治療膽、胰疾病的臨床運(yùn)用中更是發(fā)揮了其他醫(yī)學(xué)影像辦法難以替代的作用，極大擴(kuò)展了內(nèi)窺鏡的臨床使用規(guī)劃。

　　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.

　　此次發(fā)布的《YY/T 1676-2020超聲內(nèi)窺鏡》職業(yè)標(biāo)準(zhǔn)對超聲內(nèi)窺鏡專用的性能目標(biāo)、安全目標(biāo)、檢測辦法等進(jìn)行了界說和標(biāo)準(zhǔn)，使廠家、檢測組織、監(jiān)管組織在制造、檢測、閱覽過程中有章可循。一同，《YY/T 1676-2020超聲內(nèi)窺鏡》職業(yè)標(biāo)準(zhǔn)的發(fā)布，將加速超聲內(nèi)窺鏡在我國的臨床推廣和普及，成為我國相關(guān)臨床學(xué)科展開和器械制造的重要推動(dòng)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.