Inherent risks of medical devices
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Anhui Kangning Industrial (Group) Co., LTD. was founded in 2001 by Mr.Qijianning. Since the beginning of the establishment, our company always insist the business philosophy that “establishing enterprise humanely and arriving at supreme goodness” . And we insist normative , orderly , strict...

Anhui Kangning Medical Products Co.,Ltd.
  • Mrs.Redy Wang
  • Mobile:0550-7304123
  • Tel:0550-7304123
  • Fax:0550--7304177
  • Address:South of latitude three-way,west of longitude four-way,Development Zone.Tianchang city,Anhui,China.
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     "By design factors, material factors, clinical applications, medical devices also exist inherent risks." City of drug adverse reactions and drug abuse monitoring center director Zhang Cunliang said. To this end, the majority of medical device users to correctly understand, to prevent all kinds of harmful events leading to human injury. According to reports, the inherent risks of medical devices include: design factors, restricted conditions, the cognitive level of science and technology, medical technology and other factors, there are different degrees of simplicity, consider a single, design and clinical application, does not match the positioning fuzzy problems in the development process, due to design defects unavoidable; material many factors, medical material selection in industrial sources, often will inevitably face the biocompatibility, radioactive, microbial contamination, chemical residues, degradation and other practical problems; clinical application, mainly three types of equipment risk relatively large, changes in the process of using any external conditions, there may be a great risk. So, what are the basic requirements of medical device security? First is in according to predetermined conditions and use will not endanger the patients, users and other clinical condition (Health) and safety; design and manufacturing of products should conform to the safety principles known the latest technology level can be achieved; the use of the product may occur and the risk of the interest is acceptable. At the same time, should be in accordance with the following order of select security solutions: as far as possible to eliminate or reduce the risk (from the structural design and ensure safety); if the risk can not be eliminated, should take sufficient protective measures, such as necessary times alarm; will take measures to protect the still residue of risk to inform the user of.

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  • Tel:0550-7304123  Fax:0550--7304177
  • Address:South of latitude three-way,west of longitude four-way,Development Zone.Tianchang city,Anhui,China.