IEC 60601-1 Amendment 1 3rd Edition and Brazil ABNT NBR IEC 60601-1:2010

lboll

Involved In Discussions
#1
Did Brazil incorporate all of Amendment 1 from 60601-1 3rd edition into their standard ABNT IEC 60601-1:2010?
 
Elsmar Forum Sponsor

Marcelo

Inactive Registered Visitor
#2
Re: 60601-1 Amendment 1 3rd Edition and Brazil ABNT NBR IEC 60601-1:2010

No, ABNT NBR IEC 60601-1:2010 is from 2010 (seem a little obvious :)), and Amendment 1 is from 2012.

We are publishing the Brazilian version of Amendment 1 in a few months.
 

Roland chung

Trusted Information Resource
#3
Hi Marcelo,

According to the IN 3/2011, ABNT NBR IEC 60601-1:2010 must be implemented as of Jan 01, 2014. But I heard that ABNT NBR IEC 60601-1:1997 is required for sphygmomanometers since no laboratories in Brazil have been accredited by INMETRO for ABNT NBR IEC 80601-2-30.

I want to know how many kinds of medical devices that still require 2nd edition in Brazil. I try to find something through searching the Website of INMETRO and ANVISA, but get nothing.

Regards,
Roland
 

Marcelo

Inactive Registered Visitor
#4
Historically, the only way to know that is to verify at the INMETRO website each lab accreditation, and which standards they are accredited to.

However, ANVISA changed this and recently published NOTA T?CNICA N? 02/2014/GQUIP/GGTPS/ANVISA
1. Objeto: Exigibilidade da certifica??o compuls?ria pelas Normas T?cnicas listadas na Instru??o Normativa IN 9/2013, which details when mandatory certification is required.

Their website is not working at the moment, but when it gets back you can access this there.
 

Roland chung

Trusted Information Resource
#5
Historically, the only way to know that is to verify at the INMETRO website each lab accreditation, and which standards they are accredited to.
It sounds strange to me. The scope of laboratories may be different. It seems we have to search all of the laboratories.
 

Roland chung

Trusted Information Resource
#7
One more question:

Is existing equipment "grandfathered" in Brazil regarding new standards, just like the United States and Canada?
 
V

valr31

#9
Hi,
Thanks for the post,

I got a look at the ABNT published norms and was not able to find the IEC 60601-1:2005 + Amendement 1:2012.

Is that a recognized standard in Brazil or can we use the IEC 60601-1:2005 ABNT NBR IEC 60601-1:2010 ?

thanks for your feedback.

ValR31
 

Marcelo

Inactive Registered Visitor
#10
I got a look at the ABNT published norms and was not able to find the IEC 60601-1:2005 + Amendement 1:2012.
Hello ValR31 and welcome to the Cove!

As mentioned, we do not have a consolidated general standard + amendment version.

Also, our implementation of the amendment is late and has not been published yet (it will probably go to public consultation this month).

So right now we only have ABNT NBR IEC 60601-1:2010 (which is equivalent to IEC 60601-1:2005).

Is that a recognized standard in Brazil or can we use the IEC 60601-1:2005 ABNT NBR IEC 60601-1:2010 ?
We don´t have "recognized" standards in Brazil, we have mandatory standards under mandatory certification, which, in the case of medical electrical equipment, are described in Normative Instruction 11/2014 (INSTRUÇÃO NORMATIVA N° 11, DE 16 DE DEZEMBRO DE 2014).
 
Thread starter Similar threads Forum Replies Date
A IEC 60601-2-2 - Defib-proof test amendment to base standard IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
T Is a new edition of the IEC 60601 in preparation for 2019 (Amendment 2)? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Final draft of IEC 60601-1 Amendment 1 available - May 2012 IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
W Is there an IEC 60601 3rd Edition 1st Amendment? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
E PEMS Hazards - IEC 60601 Clause 14.6 - Internal data use - Pressure sensor IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
W IEC 60601 - Essential performance c.2.34 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
B IEC 60601-2-43 - Clause 203.6.103 - Physical button? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M IEC 60601-1 1988 - Device developed in 2012 with standard of 1988 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A IEC 60601-1 Dielectric Strength test for battery operated devices IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
E IEC 60601-1 - Unearthed Medical Device Metal Parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
JoCam Failure to test Class I medical device to IEC 60601-1-11 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R IEC 60601-1 - Different methods of achievement of the isolation IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
K What is mean by Oxygen Rich Environment as per the IEC 60601-1 clause no 11.2.2 IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
K Dielectric strength test as per IEC 60601-1 -Infant incubator IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A Unused SIP/SOPs - IEC 60601-1 and IEC 60601-1-2 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
K Proper document of SMPS used in infant warmer for IEC 60601-1 testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
K Sequence of testing in IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
B IEC 60601-2-10 - Accuracy of Pulse Parameters - Required Measurement Uncertainty IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
B Has anyone done an IEC 60601-1 gap analysis to IEC 60335? Medical Device and FDA Regulations and Standards News 4
K Question on whether IEC 60601-2-62 standard is applied IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
DitchDigger IEC 60601-1 subclause 5.1 - Adequate evaluation in lieu of testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
B IEC 60601 Cl. 8.4.3 - ME EQUIPMENT intended to be connected to a power source by a plug / Plug discharge IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
B Transformer Requirements - IEC 60601-1 vs. IEC 61558-2-15 IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
T Clearance and Creepage according to Subclause 8.9.1 for MOPP IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
A IEC 60601-1 and IEC 60601-2-2 IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M IEC 60601-1-2 EMC Tables IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
T Iec 60601 Impedance and current-carrying capability IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
A Bookmarking my security protected IEC 60601-1 .pdf file IEC 60601 - Medical Electrical Equipment Safety Standards Series 16
G Is impact test according to IEC 60601-1 applicable for HAND-HELD equipment if also classified as BODY-WORN? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
shimonv IEC 60601-1 Essential Performance - Is the signal accuracy specification an essential requirement? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
E ECG device without ECG REPORTS - IEC 60601-2-25: 2011 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
C IEC 60601-1-8, difference between table 4 and annex D IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
P Scope of application for IEC 60601-1-11 Medical electrical equipment — Part 1-11 IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M IEC 60601 7.1.3 Durability of Markings - Methylated Spirit or Ethanol? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
C ABS plastic : which IEC 60601-1 tests to redo? IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
Q Isolation/Insulation Diagrams - IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
pashah Looking for Usability File Template acc. IEC 62366-1 and IEC 60601-1-6 IEC 62366 - Medical Device Usability Engineering 4
P Testing lab in India IEC 60601-2-25 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
K Electromagnetic Compatibility Test IEC 60601-1-2: 2014 IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
rezayatmand IEC 60601-2-18 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipmen IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A Fire hazard classification - Clause in IEC 60601 about gauze and electricity ISO 14971 - Medical Device Risk Management 0
K IEC 60601-1 Ed. 3.1 b:2012: Replaced IEC 60601-1 Ed. 3.1 en:2012? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A IEC 60601-1 Impact test on glass touch controller IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
D IEC 60601 for a Software only Medical Device? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
C Is IEC 60601 applicable to our smart bed? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
S CTS/CSE Waveforms Testing - Partial Recognition of IEC 60601-2-25 Standard by FDA IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
S IEC 60601-1 - MOPP and MOOP Requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S IEC 60601-2-25 ECG 4 electrodes and derived leads IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
T IEC 60601-1 vs IEC 60601-1-2 4th Edition Other ISO and International Standards and European Regulations 1
P IEC 60601 11.2.2 - Oxygen Rich Environment sources of ignition IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
Similar threads


















































Top Bottom