How to meet the requirements of IEC 60601-1 going forward
Two-day practical course
Medical electrical (ME) equipment is subject to the IEC 60601 family of standards. Particular focus is on IEC 60601-1 (Edition 3.2 / incl. A2:2020), as it defines basic safety and essential performance of medical devices.
The many requirements of the standard must be addressed within your development process for ME equipment.
You want to develop safe and compliant products? Then our two-day practical course is exactly right for you.
- Content
- Introduction to the standard’s requirements
- Regulatory requirements for medical devices
- Safety philosophy of IEC 60601-1:2005 + A1:2012 + A2:2020 (and EN 60601-1:2006 + A1:2013 + A2:2021)
- Changes introduced by Amendment 2
- General requirements (scope, normative references, terms/definitions, test conditions)
- Integration with risk management (ISO 14971)
- Tests under IEC 60601-1 (e.g., leakage currents, dielectric strength, temperature, mechanical strength)
- Classification, applied parts, and protection classes
- ME equipment classification, applied parts (Types B, BF, CF), protection against electric shock; protection classes (e.g., Class I, Class II)
- Protection against electrical and mechanical hazards for ME equipment and ME systems
- Integration of usability in accordance with IEC 62366-1
- Operating controls, PEMS, and construction requirements
- Programmable Electrical Medical Systems (PEMS): software-related requirements at ME equipment level
- Accompanying documents (instructions for use, markings, symbols)
- Requirements for ME systems
- Your Benefits
- Ensure the safety of your ME equipment from the perspective of patients and users.
- Know how to establish a standard-compliant development process for your medical devices.
- Learn how to implement the normative requirements effectively and efficiently within your organisation.
- Understand the current status of IEC 60601 (incl. A2) and the resulting new requirements.
- Methods
Presentation, workshops, real-life examples, discussion, storytelling
- Target Audience
- Manufacturers of active medical devices
- R&D / Engineering staff
- Regulatory Affairs managers
- Quality assurance / quality management staff
- Personnel from Notified Bodies
- Competent authority personnel
