Seminar on Biocompatibility and EMC Studies & Testing 2 December 2011 German Centre, 5th Floor Munich Room Programme Morning Session 9.00 - 9.05am Opening remarks by Ms Margit Kunz, Deputy General Manager, SGC 9.05 – 10.15 Topic: Biocompatibility Speaker: Ms Li Yang 1. Brief introduction of risk assessment classification of medical devices 2. Introduction of Biological evaluation of medical devices 10.15 – 10.30am Tea break 10.30am - 12.00pm Biocompatibility (continued) 3. Detailed introduction of biocompatibility- ISO 10993 4. Introduction of other related biocompatibility tests- USP, MHLW etc 12.00 - 12.15pm Q&A Afternoon Session 12.15 – 1.15pm Lunch 1.15 – 2.15pm Topic: EMC Studies & Testing Speaker: Dr Deng Junhong 1. Introduction to EMC, EMC Basics, Common EMC Tests 2.15 – 2.30pm Tea break 2.30 – 3.45pm EMC Studies & Testing (continued) 2. General EMC Requirements and Tests for Medical Electrical Equipment IEC/EN 60601-1-2 EMC Testing for Medical Electrical Equipment 3.45- 4.00pm Q&A 4pm Closing & Networking Speakers’ profile Ms Li Yang is currently the Product Manager in Chemical Centre taking care of biocompatibility testing services in TÜV SÜD PSB. Ms Li Yang holds a Master Degree of Science (Biology) from National University of Singapore and Master of Business Administration from University of Birmingham, United Kingdom. Ms Li Yang has 14 years of working experiences in the area of biomedical product development and commercialization. Dr Deng Junhong is the global EMC director of TÜV SÜD Product Service and the vice president (Electrical and Electronics) of TÜV SÜD PSB, his expertise is mainly in EMC consultancy, EMC design, EMC testing and certification. Additionally, he is an committee member of IEEE Singapore EMC society, an IEEE senior member, a member of IECEE CTL EMC Expert Task Force, a member of Singapore EMC standards technical committee and an iNARTE certified EMC engineer. Prior to joining TÜV SÜD PSB in 1998, Dr. Deng was an lecturer with East China Jiaotong University in 1987 – 1995 and a senior R&D engineer with Mitsubishi Electric in 1996-1998. Dr. Deng published bunch of research papers in EMC fields and gave numbers of paper presentations at International EMC conferences. He also gave technical talks in various conferences and seminars on EMC regulations, EMC testing techniques, EMC standards, etc. and served in the committees of a few international conferences.