医疗器械临床试验的目的是评价受试产品是否具有预期的安全性和有效性。
The purpose of clinical trials of medical devices is to evaluate the intended safety and effectiveness of the testing products.
简要介绍了生物材料和医疗器械安全性评价中动物试验替代方法的研究进展。
In this article, the authors briefly review the progress of alternatives to the animal testing in the safety evaluation of biomaterial and medical devices.
采用定性杀菌试验方法，检测YN - A型医用快速灭菌器对骨科器械的灭菌效果。
Qualitative germicidal test method was used to examine the efficacy of YN-A-Type Medical Quick Sterilizer in sterilizing the orthopedic instruments.
方法采用试纸法隐血试验对杭州市区市级以上医疗单位重点科室的医疗器械清洗质量进行现场检测。
METHODS In order to rapidly detect the washing quality of medical devices, to adopt test paper for detecting the residual blood in major wards of more than 20 hospitals in Hangzhou city.
为此，我们应该加大医疗器械安全性评价动物试验替代方法的科研投入力度，以尽快实现与国际先进方法接轨。
We should spend more scientific research to animal testing alternatives of medical devices safety evaluation in order to keep up with the international advanced technology.
在糖尿病患者中进行CGM器械的临床试验证实，与血糖监测手段相比cgm血糖值的准确性(10—12)。
Numerous studies in diabetic patients tested CGM devices and demonstrated high accuracy of the CGM-derived glucose values compared with blood glucose measurements (10-12).
第十六条申请第二类、第三类医疗器械注册，应当提交临床试验资料。
Article 16 the applicant category ii and category iii medical device registration, it shall submit the clinical test data.
可进行医疗器械产品的无菌、致敏、皮肤刺激、细胞毒性等生物学评价试验。
Therefore many medical devices tests can be conducted in SHMT, such as, sterilization, sensitization, irritation, cytotoxicity, protect solution anticorrosion, etc.
临床试验资料提供方式执行《医疗器械注册临床试验资料分项规定》(见本办法附件12)。
Clinical trials material provide ways to implement the medical instrument registered clinical trial material sub-item regulations (see annex 12) of these measures.
第十七条医疗器械临床试验应当在两家以上医疗机构进行。
The clinical trial of medical apparatus and instruments should be completed by no less than two medical institutes.
医疗器械临床试验的目的是评价受试产品是否具有预期的安全性和有效性。
The aim of the clinical trial of medical apparatus and instruments is to evaluate whether the products to be tried have the expected safety and effectiveness.
每个国家在医疗器械允许进入市场前都必须通过临床试验。
At the national level, different tests including clinical investigations on human subjects, are required before a medical device is granted marketing authorization.
对美国正在进行器械临床研究豁免(IDE)试验的颈椎假体的设计特征和已出版的临床资料进行回顾分析。
A review of the design characteristics and published clinical data for cervical prostheses undergoing Investigational Device Exemption (ide) study in the United States is provided.
第五条医疗器械临床试验分医疗器械临床试用和医疗器械临床验证。
Article 5 The clinical trials of medical devices are divided into clinical testing and clinical verification.
有关补偿事宜应当在医疗器械临床试验合同中载明。
The related content of compensation should be described in the clinical trials contract of the medical devices.
SHMT拥有400多台(套)进口和国产的医疗器械检测仪器和环境试验设备。
SHMT boasts of more than 400 sets of imported and homemade testing instruments of various types as well as equipment for environmental test.
医疗器械临床试验报告。
对医疗器械产品中球压试验的操作、压痕判定、影响试验的因素进行简要论述。
A brief introduction about test operation, the judgment of the pressure trace, the impact factors of the ball pressure test in the medical devices area…
第十七条在中国境内进行医疗器械临床试验的，应当严格执行《医疗器械临床试验规定》。
Article 17 in the territory of China for medical equipment of clinical trials, shall strictly implement the clinical trials of the medical device regulation "."
第十八条在中国境内进行临床试验的医疗器械，其临床试验资料中应当包括临床试验合同、临床试验方案、临床试验报告。
Article 18 in the territory of China for clinical trials of medical devices, the clinical test data shall include clinical trials contract and clinical trial scheme, clinical study reports.
方法介绍医疗器械生物学试验的特点、生物学评价的原则及生物学试验的实施要点。
Methods Introducing the characters of biological test, principle of biological evaluation as well as important points to perform biological evaluation.
方法介绍医疗器械生物学试验的特点、生物学评价的原则及生物学试验的实施要点。
Methods Introducing the characters of biological test, principle of biological evaluation as well as important points to perform biological evaluation.
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