ABSTRACT
At present, the most commonly used sterilization method for medical devices is ethylene oxide sterilization. The residue after sterilization is closely related to the health of the people who contacted with the medical devices. The study team analyzed the possible residues of medical devices after sterilization with ethyleneoxide. It is suggested that ethylene oxide, 2-chloroethanol and ethylene glycol should be evaluated comprehensively through the analysis of factors such as production links of medical devices, production process of ethylene oxide, sterilization process, sterilization environment and detection method.
Subject(s)
Humans , Equipment and Supplies , Ethylene Oxide , SterilizationABSTRACT
From the point of view of medical device registration technical evaluation, production process of endoscope, three-dimensional imaging(3D), high resolution imaging are discussed. We focus on the process of design and development, especially verification and validation. The general principle is that all risks and unexpected impacts should be minimized and acceptable to ensure that benefits are greater than risks in normal use.
Subject(s)
Endoscopes , Equipment Design , Imaging, Three-DimensionalABSTRACT
In this paper,standards for active implantable cardiac medical devices are discussed.Potential EMC risks and its correspondent tests settings as well as the design principle of the tests have been analyzed.The problems arises from the difference between domestic and international standards on the limitation of exposure of the general public to electromagnetic fields and the lack of assessment of EMC risk which generated by the the 5th generation mobile communication for the impact on the active implantable devices devices.
ABSTRACT
The regulation of mobile medical devices is one of the hot topics in the industry now. The definition, regulation scope and requirements, potential risks of mobile medical devices were analyzed and discussed based on mobile computing techniques and the FDA guidance of mobile medical applications. The regulation work of mobile medical devices in China needs to adopt the risk-based method.
Subject(s)
China , Equipment and Supplies , Reference Standards , Mobile Applications , Reference StandardsABSTRACT
Medical laser adopts optical fibers as spread media, using laser energy for the purpose of diagnostics and therapeutics. The corresponding industry standard is YY/T 0758-2009 General requirements for therapeutic laser fiber, which requires manufacturers to offer applicable wave length (or spectrum range) of the fiber, and the corresponding minimum transmission efficiency of the wave length. This research focuses on the matching of therapeutic laser fiber and laser source, to support and emphasize the importance and reasonability of relative requirements in YY/T 0758-2009.
