Is IEC 62353 Mandatory for Medical Devices?

[nikolaos]

Hello,

Are the final safety tests before putting a medical device into the market mandatory or not? Is IEC 62353 mandatory?

 

[Marcelo]

You mean final production line testing? It depends on the regulatory system. For example, they are required for Brazil.

But not by IEC 62353, IEC 62353 are for routine tests, not production line tests. For example, in the case of Brazil, you have to perform according to IEC 60601.

 

[nikolaos]

What is the meaning of clause 4.1 of IEC 62353 The following requirements apply to:
- tests before PUTTING INTO SERVICE?

 

[Marcelo]

It?s defined as: first use of the ME EQUIPMENT or ME SYSTEM after setting up at the RESPONSIBLE ORGANIZATION (meaning, after it?s set up at the hospital for example).

Production line tests are defined in the second edition of IEC 62354.

 

[nikolaos]

Thanks! Marcello

 

[nikolaos]

I had a look to IEC 62354 Ed. 2.0. There is the description of all tests required by IEC 60601-1:2005 not just the final production line tests. I riformulate my question maybe I have not been clear.

For a medical device certifidied to IEC 60601-1:2005, what are the final production line tests that must be done? Are they mandatory?
There must be some deviations as described in IEC 62354, production is not a testing lab, so the munufacturer must decide how to perform these tests in accordance with the NB?
Is there any document of how to set-up these production line tests before putting the device into the market?
Sorry for all these questions but I just try to understand.

 

[Marcelo]

Oh sorry, it?s edition 3 in fact, Annex K (informative) Production line tests (this standard will be published in a few weeks , probably), urgh :-(

 

[Peter Selvey]

Short answer: no. IEC 62353 does not apply to manufacturers and cannot be referred to in medical device regulation. IEC 62354 is a guide only, a technical report, and again cannot be referred to in regulation.

Long answer:
In general the European medical device directive always refers to design and production. While we often focus on standards in the design part, legally your obligation is, of course, more important for regular production.

There, things get interesting. The decision on whether to test in production can take into account a lot of factors, such as:

- expected variability in production
- margin to the limit
- use of certified parts
- importance of the limit or test in question
- potential for mistakes or other failures in production

In addition, production tests are often highly simplified to a spot check. Again the justification to use a spot check is based on the factors above.

Nevertheless, the law in Europe requires you to ensure compliance in production. A NB auditor cannot insist on a particular production test, but they can ask how you can ensure compliance in production for any clause in IEC60601-1. You should have a plausible answer ready.

Unfortunately many NB auditors have been trained to expect a minimum number of tests like leakage current, earth resistance, dielectric strength. Always challenge these auditors to provide evidence of the law or regulation that requires this. Some of these tests are reasonable, but ultimately it is up to the manufacturer to decide. Dielectric strength is one area of particular contention as it can be problematic in production, especially 4kV tests. Any auditor that insists on a 4kV test in production on a fully assembled device should challenged.

In general it would be wrong to try and mandate production tests in a standard, because of the huge variety of design solutions. At best we can expect a standard to give some guidance and examples, but not to explicitly state particular tests and criteria. Auditors should not twist these guides into a mandatory requirement.

 

[nikolaos]

Thanks Peter. I asked our NB about this. For sure line production tests are not mandatory from the 60601-1.
Using IEC 62353 as a guide to setup the production line safety test is acceptable for our NB. In another occasion they suggested to avoid a 4KV test as this can be descructive.

 

[GlennP731]

You mean final production line testing? It depends on the regulatory system. For example, they are required for Brazil.

But not by IEC 62353, IEC 62353 are for routine tests, not production line tests. For example, in the case of Brazil, you have to perform according to IEC 60601.

Hi Marcelo,

You had mentioned previously in this post

You mean final production line testing? It depends on the regulatory system. For example, they are required for Brazil.

But not by IEC 62353, IEC 62353 are for routine tests, not production line tests. For example, in the case of Brazil, you have to perform according to IEC 60601.

Does this mean that for dielectric strength testing according to 60601-1 8.8.3 that we cannot deviate from the 1 minute test time? I have seen test times be at 1 to 5 seconds so there less chance of the device being damaged.