无菌医疗器械生产过程中，水的制备和质量控制至关重要。
In the process of producing sterile medical instrument, the preparation of water and the water quality control are important.
基于我国人口多特点，每年的一次性使用无菌医疗器械消耗量巨大。
The annually consumption of SUD is enormous because of the big population of China.
符合国际和国内相关规范的灭菌过程是无菌医疗器械进入国际市场的前提条件。
A sterilization process, which complies with international and national standards, is prerequisite to marketing sterile medical device globally.
因公司生产的产品为一次性无菌医疗器械产品，人员与产品的接触会影响产品的质量。
Because our products are sterile medical devices for single use, their quality will be adversely affected due to contact between human and products.
本文对一次性使用无菌医疗器械的现状进行了分析，并提出了监管工作的对策和建议。
The current situation on the supervision of disposable sterile medical devices has been analyzed, and some Suggestions are offered for strengthening the supervision and management.
本文就我国目前一次性无菌医疗器械的质量状况做出调查，分析目前发生一次性无菌医疗器械不良事件的主要原因，提出改进质量与管理意见。
In this dissertation, the major causes of the current occurrence of adverse events on SUD are analyzed on the basis of their quality condition researches.
本文对医疗器械灭菌包装系统(包括无菌阻隔系统和保护性包装系统)的一些性能实验作了一个简单的介绍。
Giving out a basic introduction about the performance testing requirement of medical device sterilization packaging which includes sterilization barrier system and protective packaging system.
参与过程的三方：提供产品的生产商、实施辐照的辐照机构及提供辐照参数的实验室都对医疗器械的无菌质量有贡献。
The three parters which take part in irradiation sterilization: Manufacturer, irradiation organ and Lab offered radiation parameters, all of them contribute to quality of radiation sterilization.
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.
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.
应用推荐