BM4092 Medical Device Standards and Regulation Syllabus:
BM4092 Medical Device Standards and Regulation Syllabus – Anna University PG Syllabus Regulation 2021
COURSE OBJECTIVES:
Understand standards and safety aspects of medical devices.
Understand the hospital safety standards and maintenance.
Describe the medical equipment safety standards.
Describe medical device regulations
Describe medical device risk assessment and regulatory requirements.
UNIT I STANDRADS AND SAFETY
Quality management system for medical devices (ISO 9001 and ISO13485), safety and standardization for risk management (ISO 14971), European standard conformity (CE marking), FDA guidelines for medical devices approval and classification based on risk assessment
UNIT II HOSPITAL SAFETY STANDARDS
Life Safety Standards- Protecting Occupants, Protecting the Hospital From Fire, Smoke, and Heat, Protecting Individuals From Fire and Smoke, Providing and Maintaining Fire Alarm Systems, Systems for Extinguishing Fires Environment of Care Standards-Minimizing EC Risks, Smoking Prohibitions, Managing Hazardous Material and Waste, Maintaining Fire Safety Equipment, Features, Testing, Maintaining, and Inspecting Medical Equipment.
UNIT III MEDICAL EQUIPMENT ESSENTIAL REQUIREMENTS
General requirements for basic safety & essential performance of medical equipment, IEC 60601 standards- Base Standard-general requirement of electrical medical devices, Collateral Standards- EMC radiation protection &programmable medical device system, Particular Standards-type of medical device.
UNIT IV MEDICAL DEVICE REGULATION
Medical device and in vitro diagnostics: Introduction & types of devices including combination devices. Medical Device Rules, 2017: Implications on medical devices. Classification of medical devices. Labelling of medical devices and in vitro diagnostics
UNIT V MEDICAL DEVICE RISK ASSESSMENT
Inspection of medical device and IVD establishments. ISO 14971 (Medical devices: Application of risk management to medical devices). Regulatory requirements of biocompatibility of medical devices and ISO 10993. Clinical investigation of medical devices, regulation of investigational medical devices. Medical device regulation: International practices.
COURSE OUTCOMES:
On completion of this course the student will be able to:
CO1: Describe the key point in standard and safety of medical devices
CO2: Introduce the students with the knowledge of hospital safety and standards.
CO3: Introduce the students with the knowledge of essential requirements in medical equipments
CO4: Introduce device regulation and its types.
CO5: Acquire knowledge medical device risk assessment.
TOTAL:45 PERIODS
REFERENCES
1. Seeram Ramakrishna, Lingling Tian, Charlene Wang, Susan Liao, Wee Eong Teo, Medical Devices Regulations, Standards and Practice, Wood head Publishing, 1st Edition, 2015.
2. Joint Commission International Accreditation Standards for Hospitals, Joint Commission International, 6th Edition, 2017.
3. Joseph D. Nally (ed.), Good Manufacturing Practices for Pharmaceuticals ,CRC Press sixth edition, 2007
4. https://nptel.ac.in/courses/127106136
5. MDR17, Regulation of Medical Devices