IEC 60601 Medical Device Testing House Costs

Jeffers

Starting to get Involved
#1
Hello Elsmar,
As regulatory manager for a very small medical device manufacturer, I am often in a position where I need to educate myself on standards. We are a CE certified company, and are planning to release a new medical device into the market. The device is battery powered, and is our first "electrically powered" medical device. The device is extremely simple, no complex wiring, no complex circuitry. We have generally completed the R&D stages for the product, and are preparing a 510K submission to the FDA.
I believe our device will need to comply with the following standards:
IEC 60601-1
IEC 60601-1-2
IEC 80601-2-60:2012

I have received quotes from a few different testing houses to perform the required tests and provide a report with the results. It was recommended to me to allow one testing house to perform 60601-1 and another testing house to perform 60601-1-2.
When a company has this testing performed, does a single test house typically perform all of the testing, or is this a frequent relationship, with each testing house specializing in a certain group of tests?
If any other information is required, please let me know. If anyone has a recommendation for a testing house, that is also appreciated.
 
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Marcelo

Inactive Registered Visitor
#2
Re: IEC 60601 Testing House Costs

It depends.

It's very common for test house to test to the general standard, some collaterals (but not EMC), and some particulars.

It's also common to separate some testing (although this may create a problem because the standards should be used together). This is common for 60601-1-2 because EMC testing is usually performed at a high specialized testing laboratory (the same can be said about X-ray devices).
 
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Marcelo

Inactive Registered Visitor
#3
Re: IEC 60601 Testing House Costs

Anyway, I think it's better to test in a single test house, if possible. Besides applying the standards together as they should be, testing together might lower the price (at least, that's what happens in Brazil).
 

Jeffers

Starting to get Involved
#4
Re: IEC 60601 Testing House Costs

Anyway, I think it's better to test in a single test house, if possible. Besides applying the standards together as they should be, testing together might lower the price (at least, that's what happens in Brazil).
Marcelo,
Thank you for the prompt update. I suspect this question is not fair, but would you have any idea on a very rough price range for this type of testing? I understand how difficult that is without having an idea of the device. It is so extremely simple, the BOM has three items.
Would you expect the testing to be less than $5,000.00USD?
Between $5,000 - 10,000USD?
$10,000 - 20,000USD?
Over $20,000USD?
 

Marcelo

Inactive Registered Visitor
#5
Re: IEC 60601 Testing House Costs

The fact that the device is simple usually does not make much difference in the price, unless the test house do give discounts for tests not applied (not usual in my experience).

I have no idea of the prices of testing abroad right now, but from past experience it will probably cost between 10,000 - 20,000USD for a device which applies 60601-1, 60601-1-2, some other collateral and no particular.

Although I've seen comments that prices have hiked due to the third edition, in this case you would easily pay more than 20,000USD.
 
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Jeffers

Starting to get Involved
#6
Re: IEC 60601 Testing House Costs

The fact that the device is simple usually does not make much difference in the price, unless the test house do give discounts for tests not applied (not a usually thing in my experience).

I have no idea of the prices of testing abroad right now, but from past experience it will probably cost between 10,000 - 20,000USD for a device which applies 60601-1, 60601-1-2, some other collateral and no particular.

Although I've seen comments that prices have hiked due to the third edition, in this case you would easily pay more than 20,000USD.
Exactly what I was looking for, but not necessarily what I wanted to hear!
Thank you for the assistance, Marcelo, and for taking the time to share your knowledge and time with your thorough response.
 

Pads38

Trusted Information Resource
#8
Something that may make a difference on both cost and the use of different test houses for the base standard and the EMC standard is your use of certification marks.

When you want to be able to display a mark (such as UL, ETL) the certifying test house has to certify to all applicable collateral standards, as well as the base 60601-1. So they might not accept the test results from a third party EMC test house.

Also, certifying test hoses tend to be bigger and more expensive and, for the use of a mark, they will require production inspections.

I suspect that you will also need to add 60601-1-6 / 62366 to your list of applicable standards.
 

SteveK

Trusted Information Resource
#9
Had some quotes from a few UK test houses about a year back; for exactly this work for a low voltage device (conducting both 60601-1 & 60601-1-2), and Marcelo’s price range for the work is unfortunately about right (converting from Pounds – circa $12,000 to $24,000 in our case). The cost has probably risen since then! One test house did quote twice as much as another. Not actually had any testing conducted as yet – long term project!

Steve
 

Pads38

Trusted Information Resource
#10
I had a look back at some quotes received over the last couple of years. As Steve suggests there is a wide variation, with little to explain the differences.

First quote - CB test house, device classification IIa, mains powered, including PEMS, plus usability and a particular standard (60601-2-xx).
Excluding EMC, biocompatability, and packaging tests
£23,000

Second - ISO 17025 test house, IIa, mains powered, PEMS N/A, excluding particulars, EMC and any extras.
5,000 euro.
 
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