Medical Device Design Verification Testing - Is ISO 62366:2008 what I'm looking for?

[ApaDan]

Hi,

I used to work for a respiratory drug delivery company and was in charge on performing the Design Verification Testing on our medical devices. We followed ISO20072 to the letter as it was exactly what we were doing, "Aerosol Drug Delivery Device Design Verification - Requirements and Test Methods".

I now work for an osteobiologics company and my role is similar, perform Design Verification on our medical devices.

My problem is that I can't seem to find a standard that is in similar to ISO20072 but on general medical devices rather than aerosol drug delivery devices.

ISO62366 sounds like what I'm looking for but without paying CHF 252,00 I can't tell for certain.

Is anyone familiar with both ISO20072 and ISO62366 and can tell me if they are the same kind of thing, i.e. related to design verification? Is usability testing just another word for design verification testing?

Thanks

[Marcelo Antunes]

I´m not familiar with ISO 20072:2009 (but i´m getting it because i liked what it seemed to be), but it´s focused in one phase of the device life-cycle (design verification).

ISO 62366 has a broader, life-cycle based, always active, usability engineering process. It obviously has requirements for usability verification and validation, but general requirements.

But yes, it seem that what you are looking for is ISO 62366. Just keep in mind that you will have much more work to "fill the gaps".

[bob_north]

Hi:

In addition to what Marcelo mentioned, the usability process detailed in 62366 is indeed an end-to-end process that should be overlayed on Design Controls (FDA's Quality Systems Regulation for Medical Devices), and also parallels the process described in AAMI/ANSI's HE74, Human Factors Engineering Process for Medical Devices. You should also get a copy of this AAMI HE74 standard if you want to institute human factors in your organization. AAMI now offers a three-day workshop covering the end-to-end process and new (did I mention NEW!) requirements from the FDA regarding human factors VALIDATION studies. (Verification is something else entirely.) Also suggest finding your way to that course or email AAMI about the details, which are on their AAMI website in their events calendar.

Also, HE75 is coming out next month, which will be THE medical device human factors and user interface DESIGN standard for the near future. That one is a must for your library, though probably pricey.

Lastly, don't leave home without the FDA guidance which is used every day by FDA ODE reviewers: Medical Device Use Safety: Incorporating Human Factors Engineering in the Risk Management Process. Download it from the FDA CDRH site.

Bob

[SteveK]

Hi,

I sort of disagree with what has been indicated (I do have a copy of BS EN 62366:2008). Because of the changes to the MDD 93/42/EEC there is an increased requirement to show the usability element of a medical device – thus the standard. It ties in with the risk management requirements of BS EN ISO 14971. As such I now have a section in my Technical Files on Usability (so as with the risk assessment standard it is worth getting for gaining compliance to the MDD). However, with respect to actual testing of a device this is not the standard to use – as it does not indicate any specific tests, it is more of an overall assessment (as indicated). From what you indicate I assume that you are dealing with prosthetics, so check out the harmonised standards:

http://ec.europa.eu/enterprise/polic...s/index_en.htm

There is for example: Non-active surgical implants – Joint replacement implants, ISO 21534 and the biological evaluation series ISO 10993-n.

Bit of a coincidence, I use to work in the aerosol drug delivery device field, but never came across/used ISO 20072 (it was 10 years ago!).

Steve

[Marcelo Antunes]

Hi,

I sort of disagree with what has been indicated (I do have a copy of BS EN 62366:2008). Because of the changes to the MDD 93/42/EEC there is an increased requirement to show the usability element of a medical device – thus the standard. It ties in with the risk management requirements of BS EN ISO 14971. As such I now have a section in my Technical Files on Usability (so as with the risk assessment standard it is worth getting for gaining compliance to the MDD). However, with respect to actual testing of a device this is not the standard to use – as it does not indicate any specific tests, it is more of an overall assessment (as indicated). From what you indicate I assume that you are dealing with prosthetics, so check out the harmonised standards:

You are right, i the original answer i gave was a bit misleading.

I´ve got ISO 20072 and looked at it. It´s an interesting standard, but i don´t know of other standards like it.

Form a design standpoint, you need to have usability requirements for a device and perform usability testing for verification. So, i´t s part of the whole medical device verification step. that´s what i failed to mention early. If you need tests for other requirements, you need to lookf for othher sources (and generally there are no standards for verification and validation since these steps depend on the device and the development life-cycle). As pointed out by SteveK, IEC 62366 does not have specific tests, and that´s the main reason. You need to define specific tests for your device.

[Factoring Humans]

Bob:

Would you happen to know when the AAMI/ANSI HE75 will be released? The AAMI website indicates an estimated publication date of January 21, 2010.

[RemoteProgrammerGuru]

The most recent word from AAMI is that HE75 is due to be released in April 2010 ... probably late April.

In anticipation of the official release of HE75 and it's potential impact once the FDA fully adopts it.

If you want to follow it, Google: Medical Monitoring & Remote Programming.

[bob_north]

To the question about AAMI HE75, it's supposed to be out in late April, but keep checking the AAMI website for reality. As authors on this for the past seven years, we're all tired of waiting, but hang in there.

For a preview of HE75, check out our article in MD&DI's January issue this year (Patterson and North).

Do note that getting this standard and reading appropriate sections (clauses) that apply to your device will be helpful in the design process, but will not be the complete answer in clearing your device as far as the FDA is concerned. Risk oriented user testing is the most important thing you can do in preparing a clearance submission for the FDA. HE75 will help clear the design of errors, but it's not a substitute for testing, and testing early and often.

The validation test at the end is the 'final exam' for the user interface, which is looked upon by CDRH reviewers as the main piece of safety evidence regarding human factors. Checking off complied sections of HE75 will not get you cleared by itself. In our human factors practice, we are seeing many manufacturers being written up for incomplete validation testing design these days, so it pays to get this right.