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Title: Identification, analysis and biosafety assessment of leachates of finished plastic biomedical devices
Researcher: Malik, Nasibullah
Guide(s): Masihur, Rahman
Patel, D K
Keywords: Chemistry
Biosafety assessment
Plastic biomedical devices
Upload Date: 25-Feb-2014
University: Integral University
Completed Date: 07/11/2013
Abstract: Plastics are being increasingly utilized for the storage and delivery of life saving fluids. Although, virgin polymer generally considered being safe due to its inertness, however, the plastic products could be harmful due to migration of certain chemical additives like plasticizers, stabilizers, pigments and unreacted monomers into the stored commodity. Therefore, plastic products intended for storage and delivery of life saving fluids must be evaluated for their safety. The authority principally responsible for regulating medical devices in India, however, is the Central Drugs Standards Control Organization (CDSCO) under MoHFW. Companies must register all products with the CDSCO before the company s product can be introduced into the Indian market. Different countries have laid down various safety assessment tests and guidelines for the suitability and quality assessment of the plastics. Indian climatic conditions are quite different in comparison to the western countries. The guidelines provided by the Bureau of Indian Standards, New Delhi has recommended the test for Global migration residue for safety assessment of plastics. Several International regulatory agencies have also recommended tests for the presence of heavy metals, UV absorbing materials and oxidizable materials in the plastics used in biomedical devices as well as food packaging.
Pagination: xxxii, 172p.
Appears in Departments:Department of Chemistry

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01_title.pdfAttached File8.82 kBAdobe PDFView/Open
02_certificate.pdf31.16 kBAdobe PDFView/Open
03_abstract.pdf159.41 kBAdobe PDFView/Open
04_acknowledgement.pdf143.85 kBAdobe PDFView/Open
05_table of contents.pdf139.92 kBAdobe PDFView/Open
06_list of tables.pdf135.37 kBAdobe PDFView/Open
07_list of figures.pdf217.63 kBAdobe PDFView/Open
08_abbreviations.pdf145.68 kBAdobe PDFView/Open
09_chapter 1.pdf352.52 kBAdobe PDFView/Open
10_chapter 2.pdf298.56 kBAdobe PDFView/Open
11_chapter 3.pdf217 kBAdobe PDFView/Open
12_chapter 4.pdf960.44 kBAdobe PDFView/Open
13_chapter 5.pdf490.05 kBAdobe PDFView/Open

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