IEC-60601-1
We can help you understand and interpret the new edition of IEC 60601-1
The recently revised 3rd edition contains several important changes for you as a manufacturer of medical devices. These are some of the major changes in the standard:
Inclusion of risk management:
- Basic safety is now basic safety and essential performance (functional safety)
- The new edition has been significantly restructured
- The electrical section has been further aligned with the requirements for IT-equipment.
- The collateral standards (e g EMC, Usability etc) now have more clearly become a mandatory part of the general standard
Our consultants have been participating actively in the whole process of the rework of the 3rd edition. With their extensive experience in the industry and involvement in the standardization they have a unique position to provide support in how to understand and interpret the new 3rd edition.
We can support you through consultation and customized training. For those companies who are established customers we can offer a time bank providing instant access to support to interpret the standard.