Tag Archives: harmonized standards
FAQ: FDA Laser Notice No. 50
FAQ: FDA Laser Notice No. 50 What you need to know about Laser Safety for United States and International markets What is FDA Laser Notice No. 50? Laser Notice No. 50 is an FDA guidance document that determines what components of IEC 60825 and IEC 60601-2-22 can be used to meet requirements found in 21CFR1040... Read More
FAQs: IEC 62368-1 Replacing IEC 60950-1 & IEC 60065; What You Should Know
What you should know about IEC 62368-1 HBSE FAQ IEC 62368-1 HBSE replacing IEC 60950-1 and IEC 60065: Frequently Asked Questions In recent times new electronic devices and applications have been developed at unprecedented rates; simultaneously, the lines between technologies have been, and continue to become, blurred. Product compliance standards, and standards committees, have been... Read More
EU Updates ATEX, Medical, R&TTE & Machinery Directives for CE Marking
The European Commission has been busy updating lists of European harmonized standards for various product directives. Here are the updates to the Official Journal (OJ) of the European Union, looking back from the most recent: May 4, 2012 – Updates to the ATEX Directive (94/9/EC), the European CE directive that applies to equipment used in... Read More