BM25C11 Medical Ethics and Regulatory Standards – Semester IV – BME / MedElec – R-2025

Subject Code & Name: BM25C11 – Medical Ethics and Regulatory Standards

Regulation: R-2025

Semester: IV (Fourth Semester)

Branch: B.E. Biomedical Engineering (BME) / B.E. Medical Electronics (MedElec)

Credits / L-T-P: 3 Credits | L-T-P: 3-0-0

Course Objectives

• Introduction of Medical ethics, Bioethics and professional ethics and learn what qualifies a product as a medical device and understand why medical devices are regulated and who regulates them. Examine the journey to bring a device to market as a manufacturer, importer or distributor.

Full Unit-wise Syllabus

Unit I – Medical Ethics

Definition of Medical ethics, Scope of ethics in medicine; Bioethics and Medical ethics - Theories, Deontology & Utilitarianism, Non- Maleficence, Beneficence, Autonomy, Veracity, Justice. Autonomy & Confidentiality issues in medical practice; Ethical committee- its members and functions; Evidence Based Medicine.

Unit II – Data Standards in Healthcare

Evolution of Medical Standards; Terminology, Content, Transport and Privacy and Security Standards - HL7 – FHIR - DICOM – LOINC – ICD11 – MeSH – SNOMED – UMLS – HIPPA; International scenario - IEEE, IEC, CEN, FDA, and CE; National scenario - MDR 2017, BIS and CDSCO.

Unit III – Medical Device Standards

Bio compatibility standards - ISO 10993, General requirements for basic safety & essential performance of medical equipment. IEC 60601 standards -General requirements for electrical medical devices, Collateral Standards IEC 60601-1-XX; Standards – 60601-2 –XX; EMI, EMC and EMS; Pseudo Collateral standards – IEC 62304, IEC 82304 and IEC 62366; Risk Management 14971, IT and Audio – IEC 62368 and IEC 60950; Component’s standards - Primary and Secondary Batteries, Fuses, Optocouplers, Plastics and Y-cap.

Unit IV – Hospital Accreditation and Safety Standards

National Accreditation Board for Hospitals (NABH 6th edition Jan 2025) – Patient centred and Management centred; NABH (Digital standards); Handling Biomedical waste and disposal as per standards; NBC and NEC – 2023 standards applicable to hospitals, Electrical and Life Safety Standards, Protecting Occupants, Protecting the Hospital from Fire, Smoke, and Heat, Systems for Extinguishing Fires; Environment of Care Standards; AERB Compliance – Radiation protection AE(RP)R-2004, Safety Code AE/RF-MED/SC-3.

Unit V – ICMED 13485 Plus

ISO 9001, ISO 13485, ICMED 9000 scheme, ICMED 13485 scheme and Indian Certification of Medical Devices (ICMED) 13485 Plus - Quality Management Systems - Management Responsibility - Resource Management - Product Realization - Measurement, Analysis and Improvement; ISO 14001, ISO 45001 and e waste management and disposal, R2 certification. Startups – State and national initiatives - TRLs and applicable standards for each TRL.

Unit VI – Medical Equipment Safety Standards

ISO/IEC 17025:2017 standard – Scope, Normative references, Terms and definitions, General requirements, Structural requirements, Resource, Process and Management requirements, Internal audit and NABL approval processes and manuals.

Activities: Case study on standards and regulatory compliance required for a medical device from design to commercialization / Case study on documentary requirement in biomedical department in a hospital pertaining to NABH standards.

Course Outcomes (COs)

• CO1: Explain the fundamental principles of medical ethics, bioethics, and professional ethics, including autonomy, confidentiality, beneficence, and justice.
• CO2: Analyze healthcare data standards (HL7, FHIR, DICOM, LOINC, ICD11, SNOMED, HIPAA) and understand their role in interoperability, privacy, and security
• CO3: Evaluate medical device standards, hospital accreditation norms, and regulatory frameworks (ISO 10993, IEC 60601, NABH, MDR, ICMED 13485) for compliance and safety.
• CO4: Apply knowledge of standards and regulations to implement quality management systems, e-waste management, and compliance procedures in medical device development and healthcare settings.

Assessment Pattern (Quick Note)

• Weightage: Continuous Assessment 40% | End Semester Examinations 60%
• Internal methodology: Case studies (40%), Group discussion(20%), Internal Examinations (40%)

Source: Official Anna University – B.E. Biomedical Engineering R-2025 Syllabus
Last Updated: October 2026