Test report requirements - Signature required? ISO 7176-19

D

Dosumi

#11
OK everyone I have a new twist in the certification question.

The University that tests our product was asked if we could self-certify our wheelchairs to ISO 7176-19.
They said " yes, you can as WC-19 and ISO-7176-19 are virtually the same, except for two clauses and if your chairs meet these requirements that we could self-certify”

Some relevant information
Our test results do meet the two requirements of ISO 7176-19.
The University states that the WC-19 testing information is provided so the manufacturer can self-certify their products.
We are not ISO certified and neither is the university testing facility.

Has anyone heard of self-certifying to an ISO requirement?
If so, how would we go about doing this?

Thanks
Don
 
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Al Rosen

Staff member
Super Moderator
#12
Dosumi said:
OK everyone I have a new twist in the certification question.

The University that tests our product was asked if we could self-certify our wheelchairs to ISO 7176-19.
They said " yes, you can as WC-19 and ISO-7176-19 are virtually the same, except for two clauses and if your chairs meet these requirements that we could self-certify”

Some relevant information
Our test results do meet the two requirements of ISO 7176-19.
The University states that the WC-19 testing information is provided so the manufacturer can self-certify their products.
We are not ISO certified and neither is the university testing facility.

Has anyone heard of self-certifying to an ISO requirement?
If so, how would we go about doing this?

Thanks
Don
Yes, it depends on the directive and you still need evidence such as test reports. Now I don't know what you are trying to ultimately accomplish. How about sharing the whole story. I assumed this was for the MDD. If so, what class is a wheelchair. You have a notified body. What is acceptable to your NB?
 
D

Dosumi

#13
Thanks Al,

Our wheelchairs are class 1, meet all the requirements of the MDD, and have for sometime.
The problem we are having is with Germany and the TUV.
To sell in Germany and have the government pay for a medical device it has to pass testing by the TUV, (I believe there may be other agencies that test also) but for now, we have been using the TUV.

We can sell our chairs in Germany but the government will not reimburse the buyer, unless they are TUV approved.
The problem is not with our standard chairs it is with the transit models.
To sell the transit models we either have to retest our chairs to ISO 7176-19 or find a way to have the TUV accept the WC-19 test results we have.

As the sales are low, my boss doesn’t want to retest our chairs to ISO 7176-19 after spending all the money testing to WC-19. Since 2001, we have test 25 chairs to latest WC-19 standard. With the total expenses to test at approximately $4000.00 per chair you can see why he would rather self-certify.

The head of the department at the university testing facility when asked said yes we could self-certify. Another employee said that the TUV wouldn’t accept the data from the university because they are not an accredited testing facility.

I’m just not sure what is needed to self-certify and how to go about laying out the documentation.

Would we take the report information as stated in 7176-19 and make our own report referencing the WC-19 info or just supply the WC-19 info with some type of cover page stating that we certify these test results comply with ISO 7176-19?


Thanks
Don
 

Al Rosen

Staff member
Super Moderator
#14
Dosumi said:
Thanks Al,

Our wheelchairs are class 1, meet all the requirements of the MDD, and have for sometime.
The problem we are having is with Germany and the TUV.
To sell in Germany and have the government pay for a medical device it has to pass testing by the TUV, (I believe there may be other agencies that test also) but for now, we have been using the TUV.

We can sell our chairs in Germany but the government will not reimburse the buyer, unless they are TUV approved.
The problem is not with our standard chairs it is with the transit models.
To sell the transit models we either have to retest our chairs to ISO 7176-19 or find a way to have the TUV accept the WC-19 test results we have.

As the sales are low, my boss doesn’t want to retest our chairs to ISO 7176-19 after spending all the money testing to WC-19. Since 2001, we have test 25 chairs to latest WC-19 standard. With the total expenses to test at approximately $4000.00 per chair you can see why he would rather self-certify.

The head of the department at the university testing facility when asked said yes we could self-certify. Another employee said that the TUV wouldn’t accept the data from the university because they are not an accredited testing facility.

I’m just not sure what is needed to self-certify and how to go about laying out the documentation.

Would we take the report information as stated in 7176-19 and make our own report referencing the WC-19 info or just supply the WC-19 info with some type of cover page stating that we certify these test results comply with ISO 7176-19?


Thanks
Don
Check the MDD with special attention to annex IV. If you meet the criteria, I think you can issue a Declaration of Conformity listing all the standards that you conform to. The only issue would be relating the wc-19 standard to the ISO 7176-19 standard (make a cross reference for your records).
 
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