Fault analysis in hip prosthesis with indicators based on the new regulatory ANVISA

• Grant number: 15/04180-9
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Start date: October 01, 2015
• End date: September 30, 2016
• Field of knowledge: Engineering - Biomedical Engineering
• Principal Investigator: Wilson Carlos da Silva Junior
• Grantee: Fernanda Novaes Santos
• Host Institution: Instituto Federal de Educação, Ciência e Tecnologia de São Paulo (IFSP). Campus Guarulhos. Guarulhos , SP, Brazil

Abstract

According to the latest census of the Brazilian Institute of Geography and statistically (IBGE) , Brazil has 45 million people with special needs , which 3 million two hundred thousand with mobility problems. The new rules of ANVISA set new values for the number of cycles that the product (prosthesis) should bear the fatigue test without failure. The number of cycles applied to performance tests was 5 million and after 2013 with the change in the standard used was increased to 10 million. These regulatory changes were due to the cancellation of the standard ISO 7206-8 of 2004, with the use of ABNT NBR 7206-6 of 2013, all products being marketed should be tested based on these new parameters. This project will study the fault conditions of hip prostheses manufactured in the country with new quality indicators required by ANVISA for products that are used in the country. These tests will be conducted in conjunction with the company Ortosintese Industry and Trade, Brazilian leader in orthopedic implants, which will provide material for the tests, including raw material and finished products in stainless steel and titanium alloys. Testing should be performed in the laboratories of the Federal Institute of Education, Science and Technology of São Paulo, Guarulhos campus - IF SP Gru, the following comprehensiveness : simulation in Autoform software finite element analysis and tooling , tensile tests , tests metal forming to build forming limit curve, fatigue tests , micro hardness analysis and electron microscopy inspection with an increase up to 100 thousand times. The work will be developed by two students from the Industrial Mechatronics courses is planned to last for 12 months. The Ortosintese Company will follow the procedures, and fortnightly progress of the work will be discussed in meetings with the company and IF SP Gru, the working group will consist of four students of the IF SP Grunge course of Industrial Automation.