IEC 60601-1-2:2014, 4th edition, references CISPR 11:2010 (a.k.a. EN 55011), had no radiated rf emissions requirements for group 2 devices (intentional radiators) between 150kHz and 30 MHz. This is the basis for all group 2 medical devices on the market today.
IEC 60601-1-2:2020, edition 4.1, got fast tracked by the FDA since it contains new immunity tests (table 11 – RFID requirements based on AIM 735131 standard values) that they want manufacturers to do immediately. In that 2020 standard, 60601-1-2 references CISPR 11:2015 + A1:2016 + A2:2019 version that inherits a new group 2 only RF radiated emissions test with limits that apply for 150kHz – 30 MHz.
CEN & CENELEC Accepts ECs Standardization Request
In my last post on this Standardization Request I didn’t expect it to pass. I didn’t get into the politics that there was a possibility of pressure from various groups for this Standardization Request to be accepted even if not
EU Commission MDR & IVDR Standardization Request List – Will it Succeed?
COMMISSION IMPLEMENTATION DECISION M/575 was issued 14 April 2021: This is a list of standards the EU Commission is hoping to Harmonize under MDR and IVDR. One of the issues is the HAS consultant has issued a negative assessment on
How to Access EU Harmonized Standards List for Medical Based Directives (Non-HTML)
Just found out that the HTML listing of the Harmonized Standards listings are not available anymore. Not that they have been up to date of late anyway but still I refer to them a lot. So, when you search for