Electrical Safety Test Requirements for Brazil

jradford · Feb 25, 2013

Recently we were audited for our ANVISA registration. One of the topics was 100% testing and Certificate of Conformance for the crash cart we use. The cart is CE marked and tested to 60601-1 3rd edition, but 100% testing is not done on each cart. I would like to push this requirment back onto the cart manufacture but I am not sure which standard I should be applying. Is it the clauses from 60601-1:2005?

This is the NC which was written up:

8.1 and 10.1-10.5 Lucid products are 5 V/12 Vdc rated USM powered from the mains through a cart supplied with an isolation transformer. The cart is supplied to Lucid by lTD Model KD6402.9. Functional Testing is conducted on the system as per procedure document 02603 Rev E, attached. Safety production line tests for earth continuity, electric strength, and leakage current tests conducted on 100% production at lTD in Germany. Lucid to obtain Safety Test Procedure from lTD including the functional procedure for the test equipment. Lucid also must obtain a CoG from lTD declaring that the safety tests have been conducted on 100% production.

Pads38 · Feb 25, 2013

One small point -
60601-1:2005 is a "type test" - it tests the design of your device and is not intended to be suitable for production tests.

This is partly due to the fact that some of the tests within are potentially destructive. For instance, the dielectric strength test (high voltage applied across insulation and held for 1 minute) can damage the insulation. This may not be such that it constitutes a test failure, but it could be still be weakened. (Production dielectric tests tend to hold for only 5 seconds).

My reading of the NC would be that you need to provide full information on what the present safety testing consists of and have a signed declaration that it is done on 100% of production.

Marcelo · Feb 25, 2013

Recently we were audited for our ANVISA registration. One of the topics was 100% testing and Certificate of Conformance for the crash cart we use. The cart is CE marked and tested to 60601-1 3rd edition, but 100% testing is not done on each cart. I would like to push this requirment back onto the cart manufacture but I am not sure which standard I should be applying. Is it the clauses from 60601-1:2005?

This is the NC which was written up:

8.1 and 10.1-10.5 Lucid products are 5 V/12 Vdc rated USM powered from the mains through a cart supplied with an isolation transformer. The cart is supplied to Lucid by lTD Model KD6402.9. Functional Testing is conducted on the system as per procedure document 02603 Rev E, attached. Safety production line tests for earth continuity, electric strength, and leakage current tests conducted on 100% production at lTD in Germany. Lucid to obtain Safety Test Procedure from lTD including the functional procedure for the test equipment. Lucid also must obtain a CoG from lTD declaring that the safety tests have been conducted on 100% production.

Right now, the regulation from INMETRO requires 100% production testing according to IEC 60601-1 second edition.

Also, please be aware that current regulations and agreements do not permit that the production line testing is evaluated by documentation. The certification body needs to go to the location. If your certification body is not doing this, they are putting you on risk.

jradford · Feb 26, 2013

100% testing to 60601-1 2nd edition is a lot more tests than just earth continuity, electric strength, and leakage current tests. Are these just the items they want data sheets on? Also, the auditor said test to 110% of limits. Is this the actual tests in 60601-1, or does Brazil have different test limits?

Marcelo · Feb 26, 2013

It's 100 % production line testing (not type testing), which are earth continuity, electric strength, and leakage current tests and functional testing.

IEC 60601 does require that some tests are performed in 110% of mains voltage.

jradford · Feb 26, 2013

Is there someplace which states which tests are run at 110% of mains voltage? I am trying to put together the information so I can push it back on the cart manufacturer. I will need to tell them the exact tests and limits I need data for.

Marcelo · Feb 26, 2013

For this case this is only for leakage current, it's on 19.1 b)

They have to follow the whole clause, anyway.

jradford · Feb 28, 2013

I think I am getting somewhere now.

For earth continuity they need to complete clause 18?

For the leakage tests they need to complete clause 19 (just subclause 19.1, or all of 19?)

For dielectric strength they need to complete clause 20 (again, the entire clause, or just a sub clause?)

So basically, I need the supplier of the cart to complete clauses 18-20 and supply a datasheet for every cart being shipped to Brazil.

New wrinkle. These tests really need to be performed on the completed system, not just the cart, right? We add computer, monitor, hand held device (plugged into the computer).

Marcelo · Feb 28, 2013

For earth continuity they need to complete clause 18?

For the leakage tests they need to complete clause 19 (just subclause 19.1, or all of 19?)

For dielectric strength they need to complete clause 20 (again, the entire clause, or just a sub clause?)

Yes, entire clause. In fact, the idea is that the same tests as performed for type testing are performed (although some can be difficult to perform).

So basically, I need the supplier of the cart to complete clauses 18-20 and supply a datasheet for every cart being shipped to Brazil.

As I mentioned before, by the rule no datasheet is needed, the certification body only need to inspect it during the audit.

These tests really need to be performed on the completed system, not just the cart, right? We add computer, monitor, hand held device (plugged into the computer).

They have to be performed on the certified equipment. If it includes cart and everything else, then you need to perform them on that.

jradford · Mar 4, 2013

I know there are all in one testers to handle these test. It looks like I will have to pick one up. Does anyone have a recommendation of equipment they use which will satisfy the requirments?

Electrical Safety Test Requirements for Brazil

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