为顺应这一需要,我所组织编写了《医疗器械检验操作规范》,本文介绍了编写的背景及进展情况。
To meet this need, our institute organizes the compilation of "standard operation procedure for medical device testing", and this article introduces the background and progress.
第三十九条国家质检总局负责对检验检疫机构实施进口医疗器械检验监督管理人员资格的培训和考核工作。
Article 39 the GAQSIQ shall take the responsibility of training and examining a qualification of IQ organs staff for the administration of inspection and supervision on imported medical instruments.
需要结合安装调试实施检验的进口医疗器械目录由国家质检总局对外公布实施。
The GAQSIQ shall publicize and implement the catalogue of imported medical instruments that require the inspection combining with their installments and adjustments.
对于植入式医疗器械等特殊产品,应当在国家质检总局指定的检验检疫机构实施检验。
The inspection of the special products such as the implanted medical instruments shall be performed by an IQ organ as appointed by the GAQSIQ.
着重提出了针对医疗器械质量检验实验室构建PLDC过程中采用的一种新兴的组网方式,即基于串口服务器的组网。
In this paper, a new kind of constructing a network method base on serial device server is provided during the construction of PLDC of the testing LAB for medical devices.
第四十八条进口医疗器械中属于锅炉压力容器的,其安全监督检验还应当符合国家质检总局其他相关规定。
Article 48 in case any imported medical instruments are the boiler pressure vessels, the safety surveillant inspection thereof shall observe other relevant provisions of the GAQSIQ.
第二十一条进口医疗器械应当在报检人报检时申报的目的地检验。
Article 21 the imported medical instruments shall be inspected at the destination where the inspection declaration is made by the inspection applicants.
第二十五条进口医疗器械经检验未发现不合格的,检验检疫机构应当出具《入境货物检验检疫证明》。
Article 25 in case no unqualified imported medical instrument is found in the inspection, a Certificate of inspection and Quarantine of Inbound Goods shall be issued by an IQ organ.
本发明属医疗器械,用于各医院检验科以及其他实验室微量加样器吸头的大批自动清洗。
The invented cleaner for suction heads is used for automatic washing of the suction heads of sampler in batches in hospital analysis department or laboratories.
本发明属医疗器械,用于各医院检验科以及其他实验室微量加样器吸头的大批自动清洗。
The invented cleaner for suction heads is used for automatic washing of the suction heads of sampler in batches in hospital analysis department or laboratories.
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