成果報告書詳細
管理番号20150000000610
タイトル*平成26年度中間年報 環境・医療分野の国際研究開発・実証プロジェクト 先進的医療機器システムの国際研究開発及び実証 現地国事情に適した高品位透析治療を達成する透析水清浄化システムの研究開発・実証(2)
公開日2015/8/13
報告書年度2014 - 2014
委託先名東レ・メディカル株式会社
プロジェクト番号P11011
部署名ロボット・機械システム部
和文要約
英文要約Title: International Research Development and Demonstration Project of Environmental and Medical Field/ International Research and Development and Demonstration of Advanced Medical Device System/ Research and Development of Water Purification System for Dialysate to Achieve High Quality Dialysis Treatment according to the affairs of each area (FY2012-FY2016)/ FY2014 Annual Report

1. Shipment of Demonstration Equipment
We held a meeting with a facility representative from The Second Affiliated Hospital of Nanjing Medical University where we conducted demonstration on site and a local carpentry work firm regarding the carpentry work in the new dialysis center in the hospital. We prepared the specification for plumbing work after studying on the machine installation in the new dialysis center. The demonstration equipment was supposed to demonstrate non-clinically but we found out that it was only permitted to import as a medical device. Therefore we set out the type test to acquire an approval as a medical device. Three models, reverse osmosis equipment (RO equipment), central dialysis fluid delivery system (central), and dialysis machine, were required to conduct the type tests but we decided not to conduct it for the RO equipment which is manufactured by Toray Medical (Qingdao) Co., Ltd. (TMQ) since it has an approval in China already. From this change we reviewed the dialysis system. We made consigning contracts for the type test with Guangdong Medical Devices Quality Surveillance and Test Center of CFDA which is one of the agencies to perform registration check of imported medical device products to proceed registration procedure smoothly for Chinese products of the central and dialysis machine. Therefore after conducting the feasible tests in Japan necessary certificates for passing the custom became to be issued from the center. We conducted the type test (electric and EMC tests) in the test facility in Japan but the impact of the difference of power supply specification between Japan and China was significant so we found out that we cannot support Chinese electric and EMC standard by only transformation where we have originally planned. After implementing the countermeasure to Chinese standard we conducted a retest for the central. As a result, we confirmed to conform to Chinese electric safety and EMC standards. We are currently studying the countermeasure for dialysis machines.
2. Demonstration with our developed demonstration equipment
The shipment of the demonstration equipment is not progressed as scheduled so we have not started demonstration. We will implement the countermeasure for Chinese standard to the dialysis machines, conduct the retest and confirm that Chinese standard is satisfied in FY2015. Additionally, we will transport and pass the custom as soon as the installation facility environment of The Second Affiliated Hospital of Nanjing Medical University becomes available, then we will start demonstration on site.
ダウンロード成果報告書データベース(ユーザ登録必須)から、ダウンロードしてください。

▲トップに戻る