If you are interested in the IEC 60601 Series of Standards for Medical Electrical Equipment (MEE) and Medical Electrical Systems (MES), this is the group that will allow you to share your experiences, ask questions and discuss your opinions. This is a platform for 60601 experts, and those that want to learn more, to discuss topics related to this large set of standards related to MEE & MES including 7 Collateral Standards (and counting) and over 60+ Particular Standards. In addition to these Particular Standards, there are many other standards that apply to MEE & MES. 

This series of standards is very important in the medical device regulatory world as the IEC 60601 series of standards are the “Gold” standard for national regulatory agencies such as the FDA, Health Canada, The EU Medical Device Directives (MDD & AIMDD), the Japanese Ministry of Health, Labour & Welfare (MHLW), and many other national regulators. Most countries adopt these standards into their national standards mostly without modification but on occasion national deviations are needed to meet the national electrical code among many other issues. 

This group is here to discuss a wide range of topics related to the IEC 60601 series of standards, the regulatory impact of these standards (such as the differences in 3rd ed. vs 2nd ed. of IEC 60601-1 & country specific regulatory impacts), the changes continually happening in this field (i.e. 3rd ed. of IEC 60601-1, IEC 60601-1, 3rd ed. + Amendment 1, etc.), what are the regulatory requirements for specific countries as they evolve (like in the Middle East & Asia), and many more topics within the medical device world are also up for play.

The group is run by Leo Eisner of Eisner Safety Consultants, an expert in the IEC 60601 series of standards, and the group is owned by IEC.  Please come and join us in this new adventure and see what you can bring to this new group and/or learn from your group members.

* NOTE:  The IEC is the owner of this LinkedIn sub-group under their main umbrella IEC LinkedIn Group.  Leo Eisner is the manager of the group and if you have any questions with regard to the IEC 60601 series of standards on Medical Electrical Equipment Sub-Group please contact Leo.