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ANVISA new rule requires IEC 60601 with Amendment 1

November 12, 2015

On September 25, 2015, the Brazil National Health Surveillance Agency (ANVISA) issued a new rule IN 4, 2015-09-24, (that supersedes the IN 11, 2014-12-16) and which require the IEC 60601-1 Ed. 3.1 (3rd edition with Amendment 1) mandatory for any new products seeking ANVISA approval.  For all projects started and quotes accepted after September 25, 2015 it is mandatory to use the 3.1 edition of IEC 60601-1:2012.

Following are some Frequently asked questions on the new rule as it applies to IEC 60601 testing and certification and UL’s interpretation:

  1. Will  UL projects with 60601-1 3.0 ed. which started before September 25, 2015 still receive ANVISA approval? Yes. All UL INMETRO Certification projects that started before the publication of the new ANVISA IN Nr. 4 can still be issued without the IEC 60601-1 Amendment 1 of 2012. If the date of the quote acknowledgement is before September 24, 2015, we can perform the INMETRO Certification without the IEC 60601-1 Amendment 1:2012. This decision was confirmed between UL and other Brazilian Notified Bodies in a meeting in Sao Paulo - Brazil. The decision was taken in order to not penalize our customers and to keep the agreement that we have made with them.
  2. For EMC, is standard IEC60601-1-2, 3.0 ed. (2007) still acceptable? Yes. Because the listed Brazilian standard according the current ANVISA IN 4, is a translation of the 2007 edition.
  3. If I have an existing certificate with 3.0 does it have to be upgraded by this notification? No. The rules apply only for new products and when the products are submitted to recertification.
  4. When does the existing cert with 3.0 need to be upgraded? Only when the current certificate expires and a recertification is requested by the customer.
  5. Does 60601-1-6 have to be issued in ILAC lab? No. The Engineering file shall be evaluated by the certification body according to IEC 60601-1-6. A laboratory report can be used but the documents listed on it shall be provided and the certification body shall check the compliance.
  6. Also, what is required for 60601-1-9? IEC 60601-1-9 will be required only on December 2016 and only some clauses (4.1, 4.5.2 and 4.5.3) will be required. There will be more discussion regarding this standard.
  7. Can an INMETRO Certification still be based in the 60601-1 second edition? Yes, but only in cases where the Particular Standard does not have a 3rd edition published yet. Example: IEC 60601-2-40 - Particular Requirements for the Safety of Electromyographs and Evoked Response Equipment. In this case, all test reports used in the Certification process needs to be provided still acc. to the 2nd edition.

Note: When the 3rd edition of the IEC 60601-2-40 is published, it can also be used in the Certification Process.

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