Mandatory tests for IEC 60601-1

sangeetha

Registered
Hello everyone,

A medical device to be tested against the IEC 60601-1 (Type BF) standard for our company. So, I would like to know - Is there a mandatory list of tests (or, minimum tests) for IEC 60601 series which must be performed on any medical electronic device to confirm that it functions properly?

Is the following list of tests sufficient to ensure that the medical device will function properly and it can be used on patients? Or, should there be more tests included?
  1. General Requirements
  2. Power Input Test
  3. Classification of ME Equipment and ME Systems
  4. Identification, Marking and Documents
  5. Leakage Current & Patient Auxiliary current
  6. Voltage Drop Test
  7. Battery Testing
 
Last edited:

yodon

Leader
Super Moderator
60601-1 testing won't confirm that it functions properly; the intent is to determine if it's safe throughout the test conditions. I think all the tests in the standard would be executed plus any tests from applicable collateral standards.
 

sangeetha

Registered
Sorry, I made a mistake! Thank you for your response, Yordan.

I'd like to reframe the question: Is the given list of tests sufficient to confirm that the device will be safe to use on patients?

Because, according to the IEC Standards document, some tests (such as the Dielectric Strength Test) can be harmful to the product.
 

yodon

Leader
Super Moderator
Indeed, there are some pretty rough tests (drop, fluid ingress, etc.) and so you likely wouldn't want to use the devices that undergo that testing for anything else.

It's unlikely that JUST 60601-1 is the complete set of tests. There are call-outs to collateral standards throughout. For example, 60601-1-2 (EMC) is done for all electrical devices.

Normally, a reputable test lab can prepare a quote based on the tests they would envision that are required. (They have been known to miss some, though! This results in additional time / cost.)
 

Benjamin Weber

Trusted Information Resource
The applicable tests of IEC 60601-1 depend on a lot of different characteristics of the device under test. From my experience this can be up to 50 or even more.
In addition some tests might become necessary depending on other test results.
So it is usually not possible for a test lab to set up a complete list of tests. But it should be possible to rule out certain tests in advance.
Actually I Always try to talk to the development engineers for at least one hour directly in order to get to know the product and its individual characteristics to finally make a reliable quotation. This is almost impossible by simply using checklists or similar.
 

sangeetha

Registered

Yes, the applicable tests for this series have a lot more tests which is why, we want to know the minimum tests for IEC 60601-1 standard that's mandatory. We have a couple of tests but we just need to make sure that, we aren't ruling out any basic tests.
 

Benjamin Weber

Trusted Information Resource
As I already mentioned above: It depends strongly on the device under test. From my point of view you cannot say there are "mandatory" tests, because this implies there are "voluntary" tests. There are tests that are applicable and others are not. But again: Without knowing much more details about the device, you cannot say more.
 

Adrienne

Registered
As I already mentioned above: It depends strongly on the device under test. From my point of view you cannot say there are "mandatory" tests, because this implies there are "voluntary" tests. There are tests that are applicable and others are not. But again: Without knowing much more details about the device, you cannot say more.

Hi Benjamin, can testing to IEC 60601-1 be carried out in-house? We have had a third party conduct our EMC testing and Electrical Safety testing.
 
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