IEC 60601
IEC 60601 Consultancy & Training
Lorit Consultancy’s team has years of experience in the implementation and application of the IEC 60601 series of standards for safety requirements for medical electrical (ME) equipment and systems.
Whether you need consulting, support or training – we support your team with our expertise in safe product design.
Why is the IEC 60601 standard of great importance?
Basic safety and essential performance of ME equipment and ME systems are fundamental requirements for medical devices to minimise the likelihood of harm during their use. These requirements range from correct classification and protection against hazards through to safe design.
The IEC 60601-1 standard is a prerequisite for the market introduction of medical devices in many countries. Therefore, a clear understanding of the standard is crucial in the development of ME devices and systems.
IEC 60601 Relation to other standards
For the launch of products in global markets, a comprehensive understanding of the regulatory landscape is required, i.e. which standards or international directives may influence the requirements of IEC 60601-1.
IEC 60601-1 is primarily focused on device safety and is strongly linked to ISO 14971. Risks can be very diverse and involve many different factors that require broad expertise.
Both in our training courses and consultancy support we guide you through the IEC 60601 family of standards and the associated standards such as IEC 60664, IEC 60825, IEC 65029.
Our services
Consultancy & Support:
- Risk analysis, FTA, HAZOP, STPA & FMEA
- Hardware and software reviews
- Preliminary hazardous analysis
- Usability reviews and analysis
- Cybersecurity analysis
- Definition risk control mechanism
Training:
We offer (online) training courses that can be customised to meet your requirements in terms of date, format and content.
In our IEC 60601 Introductory or IEC 60601 Advanced courses you learn the basics or implementation and application of the standard with work examples, team exercises and based on our industry knowledge and experience.
Gain practical insights into safe design, classifications and hazard protection in our basic course, or learn more about electrical hazardous, EMC techniques, methods for PEMS and more in our advanced course.
