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.
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.
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.
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.
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.
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;
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.
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.
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.
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.
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.
应用推荐