ANVISA (The Brazil National Health Surveillance Agency) issued the rule IN 4 on September 24, 2015  (that superseded the IN 11, dated December 16, 2014) which requires the standard ABNT NBR IEC 60601-1:2010 + Emenda IEC:2012 – the Portuguese translation of IEC 60601-1:2005 + Amendment 1:2012 (Edition 3.1 or 3rd edition + Amendment 1).  This standard is required for any new product seeking ANVISA approval since September 24, 2015 and going forward.

Before we get to the 60601-1-9 issue let’s talk a little about which version of 60601-1 applies.  If you have an INMETRO certificate that met 60601-1 3rd ed. you are ok until you have to rectify your product or your certificate expires.  If the Particular Standard 60601-2-XX  is still based on the 2nd ed. of 60601-1 then you still can use the 2nd edition of 60601-1.  But check the IN 4 before you move forward that way to make sure you are using the proper version of the applicable standards.  For the EMC standard you only need to deal with the 60601-1-2 3rd ed. which is equivalent to the 2007 edition of IEC 60601-1-2 and is the less stringent standard compared to 4th ed of 60601-1-2.

Along with 60601-1 there were a long list of other 60601 based standards in the Notice including the 60601-1-9 standard for “environmentally conscious design of medical electrical equipment”.  If you would like a copy of this notice please e-mail me at Leo@EisnerSafety.com.  I believe that Brazil is the first country that is mandating the use of 60601-1-9 . The full IEC standard title is “IEC 60601-1-9:2007 + Amendment 1:2013 Medical electrical equipment – Part 1-9: General requirements for basic safety and essential performance – Collateral Standard: Requirements for environmentally conscious design“.  The Brazilian version of the standard is ABNT NBR IEC 60601-1-9:2014 which is translated into Portuguese and the text is identical to IEC 60601-1-9:2007 + A1:2013.

ANVISA is requiring compliance to the standard by December 1, 2016 specifically for the clauses 4.1, 4.5.2 and 4.5.3 of the standard.  So, the documentation needed will include the identification of environmental aspects (clause 4.1), instructions for minimizing environmental impact during normal use (clause 4.5.2), and information for end of life management (clause 4.5.3). 

If you need help with IEC 60601-1, any in the Series of Standards or any National Version of these standards please email Leo Eisner at Leo@EisnerSafety.com, or call Leo at +1 (503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants.