How to Meet the Requirements of IEC 60601-1 in the Future
Medical Electrical Equipment is subject to the requirements of the IEC 60601-1 family of standards. The primary focus is on IEC 60601-1 (Edition 3.2 incl. A2:2020), as this standard defines the basic safety and essential performance characteristics of medical devices.
The many different requirements of the standard must be taken into account in the development process for your medical devices.
Do you want to develop safe and standards-compliant products? Then our two-day application course is just right for you.
- Content
- Introduction to the Standard 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
- Integration into risk management
- Tests in IEC 60601-1
- Classification, application parts, and protection classes
- Electrical and mechanical hazards posed by medical electrical equipment and medical electrical systems
- Incorporation of usability according to IEC 62366-1
- Controls, PEMS, and design requirements
- Accompanying documents
- System requirements
- Your Benefits
- You will ensure the safety of your medical devices from the perspective of patients and users.
- You will learn how to establish a standards-compliant development process for your medical devices.
- You will learn how to effectively and efficiently implement regulatory requirements within your organization.
- You will be familiar with the latest version of IEC 60601 and the resulting new requirements.
- Methods
Instructor-led sessions, group exercises, facilitated case studies, practical exercises, individual work, real-world case studies, discussions, live coaching, storytelling.
- Target Audience
- Manufacturers of active medical devices
- Employees in development departments
- Regulatory affairs managers
- Quality assurance/quality management staff
- Employees of notified bodies
- Employees of regulatory authorities
