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.
目的：评价一种新型坚固内固定器械用于治疗犬下颌骨线性骨折的生物力学稳定性。
Objective To evaluate biomechanical stability of a rigid internal fixation device used for treatment of mandibular linear fracture in dogs.
医疗器械制造商然后根据其满足所制定规格的能力评价其供应商，合同承包商及顾问。
The manufacturers shall then assess their suppliers, contractors, and consultants based on their ability to meet the established specifications.
目的：评价手术显微镜下结合超声装置取出根管内折断器械的效果。
Objective: To evaluate the effects of the microscope and ultrasonic technique for the removal of fractured root canal instruments.
目的比较两种常用的细胞毒性检测方法在医疗器械生物学评价中的相关性。
Objective To study the relativity between two in vitro cytotoxicity test which used in biological evaluation of the medical device.
目的评价调整手术室器械护士上班时间后的效果。
Objective To evaluate the effect of regulating traditional working time of instrument nurses in operation room.
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.
用于临床评价或性能评价的医疗器械不可以放行为客户使用。
A medical device used for clinical evaluation or performance evaluation is not considered to be released for use to the customer.
医疗器械是与药品一样需要评价风险与利益的产品。
The same with the medicine, medical device also need to be estimated their risks and benefit.
目的观察at P生物荧光法用于评价医疗器械清洗质量。
Objective To apply the ATP bioluminescence assay for evaluating the cleaning degree of medical instrument.
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.
医疗器械是与药品一样需要评价风险与利益的产品。
Medical apparatus and instruments is the product that needs to evaluate risk and interest like medicines and chemical reagents.
为了较好的解决这个问题，本文首先通过故障树分析（简称FTA）的学习，探讨用故障树分析法作为眼科医疗器械产品质量可靠性评价模型的基础。
To settle this question better, this thesis discusses to use FTA as the base of product quality reliability evaluation model of ophthalmic medical instrument by learning FTA;
前言：目的：评价可拆卸腹腔镜器械的灭菌效果。
Objective: To evaluate disinfection effect of able-dismantled celioscope instruments.
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.
生物材料和医疗器械的生物学评价是当前生物材料和医疗器械市场和应用能否健康蓬勃发展的关键。
The biological evaluation of biomaterials and medical devices is a key point for developing the market and application of biomaterials and medical devices.
本文综述了加拿大医疗器械不良事件监测系统，旨在为我国医疗器械不良事件监测和再评价体系的建设提供参考。
Medical device adverse event monitoring system in Canada were reviewed in this article, aim to provide some reference to China's system construction.
口径MEGARAD 2081-6lr进行了评估标准方面10993(医疗器械生物学评价)，并在批准的医疗应用使用。
CALIBRE MEGARAD 2081-6lr has been evaluated with respect to ISO 10993 (Biological Evaluation of medical Devices) and is suitable for use in approved medical applications.
目的作者设计一种新型脊柱内固定器，该生物力学测试对该器械进行评价。
Objective to evaluate the new designed spinal internal fixator (CYL) with the biomechanical study.
目的评价使用两种镍钛器械预备磨牙根管的临床疗效。
ObjectiveTo evaluate the clinical effects of two kinds of nickel-titanium instruments in root canal preparation.
方法：进行一项评价制动器械对刹车时间影响的前瞻性观察性研究。
METHODS: A prospective, observational study was conducted to assess the effect of the immobilization devices on braking times.
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.
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.
目的评价用器械缝合法和丝线环扎法在肺癌肺切除术时处理支气管残端的优缺点。
Objective To compare staples with sutures for closing bronchi in pulmonary resections for lung cancer.
目的评价用器械缝合法和丝线环扎法在肺癌肺切除术时处理支气管残端的优缺点。
Objective To compare staples with sutures for closing bronchi in pulmonary resections for lung cancer.
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