The change of IEC 60601-1 3rd Edition led to many improvements over the past several years
in the managing of security and risk for electrically powered medical devices which come in direct contact with patients.
In the coming months, the first amendment to 3rd edition will be published. The amendment was necessary as some technical details were not finalized at the time of publication of IEC 60601-1:2005 in December 2005, and these clarifications would have meant a long delay of the publication of the standard. The IEC technical committee 62 had the tasks:
- Resolve issues left over from the third edition project.
- Improve some of the new test methods introduced into the third edition.
- Clarify some of the requirements for risk management within the standard and provide additional guidance on its application.
- Provide additional guidance for determination of essential performance.
The result will be over 100-page supplementary document to the aforementioned tasks, which implicate no fundamental innovations.
RRC power solutions is a DIN EN ISO 13485 certified manufacturer of medical devices, and has already developed its product designs to the 3rd edition before the edition was finalized. The continuation of the development of the 3rd edition with the present amendment was followed by RRC engineers over the last few years. Take advantage of this experience in your next medical development!
Contact: Ms Annie Lin
Add: 503,Tianrun Building,No.259 Huangpu Avenue,Tianhe,Guangzhou,Guangdong,China