Electrical code Compliance - Validity/Strength of IEC standards

Author

Validity/Strength of IEC standards

rover8898

2006-02-08, 2:21 pm

Hello,

I work for a small company that has developped a medical device. We are
presently looking into the medical device's certification.
We/I know little about standard certification.
Upon looking at the various standards which the medical device
can/should be certified for:
UL-60601-1(United States),
IEC-60601-1(more or less international),
EN 60601-1 (Europe) + CE mark
& CAN/CSA 22.2 601.1 (Canada)

I came to the conclusion that it will best for us(our small company) to
only certify our medical device to the IEC-60601-1(-X) standards since
they are of an INTERNATIONAL nature and to the CAN/CSA 22.2 601.1
standard since we are located in Canada and as such are required by law
to have a CSA certification.
However a UL technician told me (over the phone) that an IEC
certification for a specific IEC 60601 standard (IEC 60601-X-X) is, BY
ITSELF, "weak" and "meaningless". To paraphrase the technician words,
an IEC 60601-X-X standard cited in a spec/datasheet is just a claim the
device's company makes (regardless of the device ACTUALLY complying to
and being certified to the standard). Without the weigth of a reputable
testing facility/product certification organisation (e.g. UL), the IEC
60601-X-X standard remains just that: a claim. The UL technician then
proceeded to explain me how the UL 60601-1 standard HAS merit (because
of the 2 little letters U and L :-), it seems that retailers look for
THEM in particular), despite the UL-60601-1 standard being in fact a
composite of several IEC 60601-X-X standards (w/ deviations), depending
on the nature of the medical device.
To summarize: UL-60601-1 + additionals IEC 60601-X-X = HAS MERIT
only IEC 60601-X-X = very very
little MERIT

Is this true? Is the IEC standard perceived to be a hollow one? Is it
maybe because an IEC standard, without the seal of approval of UL or
CSA, is perceived as incomplete? What if one was to cite "complies with
IEC 60601-X-X --verified in UL or CSA or some other valid product
certification organisation" in the datasheet? will that give validity
to the IEC standard?

I am asking the above questions because due to cost issues, I am
thinking of recomnending the bare minimum certification (for the time
being) which turns out to be a [quick special inspection approval] from
the CSA (not exactly the CAN/CSA 22.2 601.1 standard, but I have been
told it should be enough for Health Canada, the organisation
responsible for the issuing of a medical device lisence ). And I would
also like to certify the medical device for certain IEC-60601-X-X
standards in order to add credance to our medical device. Thus, it
would be pointless to obtain IEC standard certificates if they mean
very little by themselves.
Please advise.

Regards,
Roger

P.S The CE mark is NOT required in North America, rigth? I know it is
mandatory for Europe (EEC), but I am not 100% certian that it is NOT
mandatory in N.A.

Michael

2006-02-08, 5:21 pm

"rover8898" <rover8898@hotmail.com> wrote in news:1139419388.440721.61700
@g43g2000cwa.googlegroups.com:

[snip]
> Upon looking at the various standards which the medical device
> can/should be certified for:
> UL-60601-1(United States),
> IEC-60601-1(more or less international),
> EN 60601-1 (Europe) + CE mark
> & CAN/CSA 22.2 601.1 (Canada)
>
> I came to the conclusion that it will best for us(our small company) to
> only certify our medical device to the IEC-60601-1(-X) standards since
> they are of an INTERNATIONAL nature and to the CAN/CSA 22.2 601.1
> standard since we are located in Canada and as such are required by law
> to have a CSA certification.

You will have to use the standards applicable for your target markets,
those are relevant.

> However a UL technician told me (over the phone) that an IEC
> certification for a specific IEC 60601 standard (IEC 60601-X-X) is, BY
> ITSELF, "weak" and "meaningless". To paraphrase the technician words,
> an IEC 60601-X-X standard cited in a spec/datasheet is just a claim the
> device's company makes (regardless of the device ACTUALLY complying to
> and being certified to the standard). Without the weigth of a reputable
> testing facility/product certification organisation (e.g. UL), the IEC
> 60601-X-X standard remains just that: a claim. The UL technician then
> proceeded to explain me how the UL 60601-1 standard HAS merit (because
> of the 2 little letters U and L :-), it seems that retailers look for
> THEM in particular), despite the UL-60601-1 standard being in fact a
> composite of several IEC 60601-X-X standards (w/ deviations), depending
> on the nature of the medical device.

The IEC standard is a generic standard. Other standards (UL/EN/CSA etc..)
are actually derived from the IEC standard. You will have to cope with
national deviations, the test lab will (hopefully) be able to help you in
setting up the right tests and the correct documentation, so the
certification for the different flavors of that IEC standard will mainly be
paperwork.
UL issue the standards for US and they offer the certification. This is a
special situation and they can use it to their advantage ...
I do not know the medical standards well, but for the IEC/UL/CSA/EN 60950
you do not have to go through UL for a certification - TUEV will do a NRTL
certification which is just as valid. The only drawback from the point of
view of some people is that the UL brand is more popular.

This:
http://www.601help.com/index.html
could be of some help.

The UL 60601-1 is also in the NRTL program, see:
http://www.osha.gov/dts/otpca/nrtl/index.html
You will find it after some browsing on this page:
http://www.osha.gov/dts/otpca/nrtl/allstds.html

> To summarize: UL-60601-1 + additionals IEC 60601-X-X = HAS MERIT
> only IEC 60601-X-X = very very
> little MERIT
>
> Is this true? Is the IEC standard perceived to be a hollow one? Is it
> maybe because an IEC standard, without the seal of approval of UL or
> CSA, is perceived as incomplete? What if one was to cite "complies with
> IEC 60601-X-X --verified in UL or CSA or some other valid product
> certification organisation" in the datasheet? will that give validity
> to the IEC standard?

See above, IEC creates generic standards, countries can use these standards
to create their local standards. You have the same situation with CISPR
(e.g. CISPR 22 being the generic standard for EN 55022 and corresponding
VCCI standard).
Just to make you see the difference - CISPR 22 is not used in the US or any
derivative as FCC part 15 is already in place.

> I am asking the above questions because due to cost issues, I am
> thinking of recomnending the bare minimum certification (for the time
> being) which turns out to be a [quick special inspection approval] from
> the CSA (not exactly the CAN/CSA 22.2 601.1 standard, but I have been
> told it should be enough for Health Canada, the organisation
> responsible for the issuing of a medical device lisence ). And I would
> also like to certify the medical device for certain IEC-60601-X-X
> standards in order to add credance to our medical device. Thus, it
> would be pointless to obtain IEC standard certificates if they mean
> very little by themselves.

From a testing perspective it could be helpful to start with the IEC
standard and see what the national deviations are in order to integrate
them into your tests. The rest should be more or less paperwork.
Certification bodies present in different countries are likely to be more
helpful, as the recognition across borders is easier.

[snip]
> P.S The CE mark is NOT required in North America, rigth? I know it is
> mandatory for Europe (EEC), but I am not 100% certian that it is NOT
> mandatory in N.A.

You need CE for the EEC.

Before heading for the tests, gather all information and go through that
information with a knowledgeable person. This extra time you spend will pay
off later.

HTH

Michael

SQLit

2006-02-09, 4:21 pm

"rover8898" <rover8898@hotmail.com> wrote in message
news:1139419388.440721.61700@g43g2000cwa.googlegroups.com...
> Hello,
>
> I work for a small company that has developped a medical device. We are
> presently looking into the medical device's certification.
> We/I know little about standard certification.
> Upon looking at the various standards which the medical device
> can/should be certified for:
> UL-60601-1(United States),
> IEC-60601-1(more or less international),
> EN 60601-1 (Europe) + CE mark
> & CAN/CSA 22.2 601.1 (Canada)
>
> I came to the conclusion that it will best for us(our small company) to
> only certify our medical device to the IEC-60601-1(-X) standards since
> they are of an INTERNATIONAL nature and to the CAN/CSA 22.2 601.1
> standard since we are located in Canada and as such are required by law
> to have a CSA certification.
> However a UL technician told me (over the phone) that an IEC
> certification for a specific IEC 60601 standard (IEC 60601-X-X) is, BY
> ITSELF, "weak" and "meaningless". To paraphrase the technician words,
> an IEC 60601-X-X standard cited in a spec/datasheet is just a claim the
> device's company makes (regardless of the device ACTUALLY complying to
> and being certified to the standard). Without the weigth of a reputable
> testing facility/product certification organisation (e.g. UL), the IEC
> 60601-X-X standard remains just that: a claim. The UL technician then
> proceeded to explain me how the UL 60601-1 standard HAS merit (because
> of the 2 little letters U and L :-), it seems that retailers look for
> THEM in particular), despite the UL-60601-1 standard being in fact a
> composite of several IEC 60601-X-X standards (w/ deviations), depending
> on the nature of the medical device.
> To summarize: UL-60601-1 + additionals IEC 60601-X-X = HAS MERIT
> only IEC 60601-X-X = very very
> little MERIT
>
> Is this true? Is the IEC standard perceived to be a hollow one? Is it
> maybe because an IEC standard, without the seal of approval of UL or
> CSA, is perceived as incomplete? What if one was to cite "complies with
> IEC 60601-X-X --verified in UL or CSA or some other valid product
> certification organisation" in the datasheet? will that give validity
> to the IEC standard?
>
> I am asking the above questions because due to cost issues, I am
> thinking of recomnending the bare minimum certification (for the time
> being) which turns out to be a [quick special inspection approval] from
> the CSA (not exactly the CAN/CSA 22.2 601.1 standard, but I have been
> told it should be enough for Health Canada, the organisation
> responsible for the issuing of a medical device lisence ). And I would
> also like to certify the medical device for certain IEC-60601-X-X
> standards in order to add credance to our medical device. Thus, it
> would be pointless to obtain IEC standard certificates if they mean
> very little by themselves.
> Please advise.
>
> Regards,
> Roger
>
> P.S The CE mark is NOT required in North America, rigth? I know it is
> mandatory for Europe (EEC), but I am not 100% certian that it is NOT
> mandatory in N.A.

I am not familiar with the exact standards that you speak of.

I know from an electrical power point of view my locality, Phoenix AZ, will
not accept any device medical/electrical device that is not UL/CSA approved.

To limit the testing needed in the beginning I would understand the target
location's needs. Solve those get some cash in-flow and then solve the
testing for the next area.

I had a manufacture provide me with a VFD motor controller that was not
CSA/UL approved for testing. (FREE) Not one of my customers would allow it
to be installed. I never un-boxed it and finally sent it back. I was told
the liability of the product to their insurance people was not worth the
risk.

billb@abc.net

2006-02-09, 5:21 pm

If you also intend to sell your product outside North America, you should
consider obtaining a CB certificate and report for your product.
See http://www.iecee.org/
This is an international scheme where a product test report issued by one
member of the scheme is accepted by another member.
If when you initially have your product tested you tell the CB lab (see the
web site for a list of the labs), the countries you intend to sell to, they
will test for any national deviation for those countries in addition to the
basic requirements of the IEC standard. You can then use the CB certificate
and test report to obtain approvals in the countries you have nominated
without having to pay for a full retest in each country. If you later decide
that you need additional countries you can either have the product tested
again by the original lab for the additional requirements and add the
results to the original test report and certificate or just get the
additional requirements tested by the certification body who will issue the
national approval.
Members of the scheme in Canada are CSA, UL and ITS. In the USA the members
are FM Approvals, ITS, Met Labs, TUV Rheinland and UL.

Of these TUV Rheinland can offer the best coverage worldwide, therefore they
can help you obtain overseas approvals directly, thus saving you the
problems of having to apply for the approval to each country where you want
to sell. Note TUV Rheinland North America are not listed as a been able to
issue a CB certificate for medical products, but they can provide the
service through their head office in Germany.
If you have any questions regarding the above post your questions to this
group and I will try to help.

Best regards

BillB

rover8898

2006-02-09, 7:21 pm

Hello

> I know from an electrical power point of view my locality, Phoenix AZ, will
> not accept any device medical/electrical device that is not UL/CSA approved.

I AM planning to obtain a CSA certification for the device; albeit a
certification of the UNCOMPLETE CSA electromedical device standard. I
was informed that it should suffice for the prototypes and they will be
affixed with a CSA label. Hence, the clients (and their insurances)
should be at ease when they see that the device is branded with the CSA
logo .

As I understand it a device MUST be CSA approved before it can be sold
in Canada (and the US). However, as I mentionned in my original post,
I thought that it would be "intelligent" to get some INTERNATIONNAL
standard certifications AFTER the minimal certification requirements
(for North America, I'll explain below) have been met. The reason WHY I
opted for this strategy was because we do not have a client for the
product. Our contacts, since we are located in North America, our all
mainly in North America. That is why I want the device to be CSA
approved. However, the product (like all medical device products) can
be used anywhere in the world and as such it would be nice if foreign
countries (outside of N. America) could see that the product is
quasi-compliant with their nationnal standards (which I am assuming
that are derivatives of the IEC standard templates).

However, now I get the impression that it would be best to get the
device certified for the IEC 60601 standard and at the same time get
it certified for the North American deviation of that particular
standard. This way, the certification process should slightly be more
expensive BUT I would end up with the device being certified to the
FULL electromedical north american standard along with the device being
certified to the IEC internationnal standard templates. Would the North
American deviation of the IEC standard be a UL or CSA standard ? (CSA
states on their website that they can certify for North America) Would
I also need a CB scheme?

Here are some more questions:
Does anyone get IEC standard certification for a particular product on
top of the standards certification he had to obtain in order for the
device to able to be sold ?
If the IEC standards are just templates for the nationnal/regionnal
product certification organisations, what good is it to be compliant to
those IEC standards? Does anyone appreciate the fact that you are
compliant to an IEC standard BUT not yet to the proper nationnal
deviation?

The product in question is a medical device that is NOT to be sold in
retail.
It is a medical gagdet that is destined for medical facilities. So
if/when a client is found abroad, we can certify the medical device to
the proper national/regionnal deviation. However, will the client
appreciate the fact that the medical device is IEC certified? Or will
it basically be the same as if we had no IEC certification since we do
not have his nationnal deviation of it? You see my dilemma.

Regards,

Roger

billb@abc.net

2006-02-10, 4:21 pm

In general terms a medical product has the be approved for the area you
intend to sell the product into.

If you go only for a CSA approval, then find you have a customer in Europe,
you will have to have the product completely retested to EN 60601 and get a
European approval before you can sell into Europe. Therefore you end up
paying twice for the testing. If you then get a customer in Japan you will
need a Japanese approval, now you will have had to pay for three lots of
testing, whereas if you have a CB certificate you only pay for the
additional testing to the national deviation, not a full retest.

The CB certificate by its self, is not a substitute for a National approval,
but is a means of reducing your costs if you plan to sell outside Canada and
the USA.

For information regarding Europe have a look at our web site at:
http://www.uk.tuv.com/web/product_t...al_devices.html

See also our Japanese web site at:
http://www.jpn.tuv.com/en/services/...ducts/index.php

If you wish to e-mail me directly send your e-mail to safety@uk.tuv.com
and mark it for the attention of BillB and I will try to advise you in more
detailed manner.
Alternatively you can call our office in Newtown CT and speak to Ben Bissel
on (203) 426-0888 (tell him you have been in touch with BIll from the UK)
and he will put you in touch with one of our medical guy over there.

Hope this is of help to you.

BillB

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