Millions of medical devices have been used today for the treatment and to support the patient.Over the past decade the medical device market had been growing quite rapidly and undoubtedly the medical devices are becoming more important in the healthcare sector.The reports shows that the global medical device market should grow at a  compound annual growth rate(CAGR) of 11.

6 \% reaching $ 40.8 billon by 2018.Competition between medical device manufactures results in these growth as all these medical companies seek to increase their profit.However small increase in medical device recall has increase the demand for testing and validation.These   modern medical devices are manufactured with different materials and components and these materials have their own chemical and physical properties.

Even though these material posses minimum risk when incorporated into the product for general use. The inclusion of these materials with medical device increase the ambit of potential safety consideration when they come in contact with human body.The potential safety consideration includes the contamination, decomposition, the migration of these materials to another part of the body and the consequence of device degradation.Even if the materials used for the manufacturing of medical devices are biocompatible but the post-production process like manufacturing process packaging, sterilization may have adverse effects on the material’s composition that will result in new biocompatibility risk. For example, contact with lubricant during the production process, leachable substances from the packaging materials may interact with the biocompatible material and results in adverse effects on these materials.Biocompatibility testing and evaluation of medical device mainly focus on the adverse effect on the human body that is caused by the materials used and also from the post-production process.When medical devices are used for the treatment purpose the patients expect that the device they use is carefully tested for functionality, performance, sterility and safety.

Therefore medical device manufacturers must thoroughly investigate their devices to meet the expectation of the patients and receive approval to market their devices.section{Objective}This present master thesis intended to provide a theoretical review of biocompatibility test and also the technical review of packaging process for the intelligent catheter.paragraph{This  thesis begins with the theoretical review of the biological safety of the medical devices i.

e biocompatibility and the ISO standards associated with biocompatibility test. The biological safety of a medical device is to ensure that the medical devices are safe for both the patient and user from both the biological and toxicology point of view.The material used for the making of medical device may be appropriate based on their cost, physical properties and avilability ,but it may contain chemical or toxic components that are harmful to the human body.Therefore ,the standards like ISO 10993 provide the the manufacture the information regarding the biological evaluation of medical device so the material can be screened at the early stage of development there by eliminating the toxic and selecting the  biocompatible and non toxic  material for the desired use.According to ISO 10993 for the overall biological evaluation of the device the following should be considereda) the material for the manufacturing of the deviceb) additives used,processes contaminant and the residuec) leachable substanced) degradation productse) other components and their interaction with the final          productf) properties and the characteristic of the final product.

}paragraph{Subsequently the review of different integration technologies for SMD and MEMS components are done regarding their risk in medical application.  This theoretical review includes the material selection for SMD resistors,SMD capacitors as well as the interposer substrate.  Also the  material  for  adhesive  bonding,wire  bonding,  soldering  and  encapsulation  are reviewed  theoretically  under  the  aspects  of  biocompatible behavior}.paragraph{Finally  demonstrator sample is prepared and the based on the studies conducted the appropriate biocompatibility test i.e cytotoxicity test  is selected for the sample.}


I'm Erica!

Would you like to get a custom essay? How about receiving a customized one?

Check it out