60601-1-12 – Eisner Safety Consultants

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

IEC 60601-1-12 Just Published – MEE & MES Intended for Use in Emergency Medical Services Environment

This is a newly released standard as of 19 June 2014. Are you ready to use this standard for your emergency medical services equipment (i.e. equipment used in and around ambulances and at locations where emergency medical services would be