Having done field labelling and listings for an NRTL, I would ask your
Customer what they need. It could be an internal company requirement for
NRTL listing or field labelling. Not necessarily the local jurisdiction
requiring it. However, if you really want to know what is locally required,
call
Not my wording. I recommend you wait until further information is
available from the website to make a decision on how to declare to the
newer Directives.
When you say, applicable from 20 April 2016 does that
the date in which
we can start declaring to
Hello Rich,
My point exactly about what products are targeted. We have been through
these discussions many times in the past and the answer always comes up
that your product specific market environment drives third party
certification.
Best
According to Annex III, there is no mention as to a date that the DoC is
signed by the signatory. Therefore, is the the last two digits of the year
in which the CE marking was affixed (for the first time) the same as the
date a signatory signed a DoC, if it appears on the DoC?
Best regards,
Ron
The following web page lists recognized standards:
http://www.hc-sc.gc.ca/dhp-mps/md-im/st
ndards-normes/md_rec_stand_im_norm_lst_2_e.html
where the following apply to EMC:
IEC 60601-1-2 Ed. 2.0, Ed. 2.1 : 2004-11-01
Medical electrical equipment – Part 1-2: General requirements for safety –
4-6: Testing and measurement
techniques - Immunity to conducted disturbances, induced by radio-frequency
fields
Ron Wellman
-Original Message-
From: Ronald R. Wellman [mailto:rwell...@wellman.com]
Sent: Thursday, May 29, 2008 5:44 AM
People who are intererested in how management responsibility is viewed by
the U.S. government might want to read up on the U.S. Supreme Court ruling
of the United States versus Park, 421 U.S. 658 (1975). This is where an
executive was found guilty under strict liability for selling unsanitary
food
Hello Sam,
I believe that IEC 60335-1 has the information you are looking for.
Best regards,
Ron Wellman
At 02:14 PM 10/29/2003 -0700, POWELL, DOUG wrote:
Sam,
IEC 60950 (EN 60950) has:
Table 3D - Range of conductor sizes to be accepted by terminals
Table 3E - Sizes of terminals for mains
Hello Ian,
Be careful in using this web site. It is not up-to-date for some countries,
especially Brazil and Thailand. They also specify an Australian plug for
Argentina, which is incorrect.
Best regards,
Ron Wellman
At 08:34 AM 10/28/2003 +, Gordon,Ian wrote:
All
I have found the
Hello Amund,
Rather than looking at this from what is required, what about what makes
sense? I wouldn't expect someone in Norway to be very pleased to only get
documentation in Japanese or Chinese. The end-user would most likely be
very dissatisfied and probably return the product. Companies
Hello Kim,
Depending on whether the chemicals used are carcinogens or reproductive
toxicants there are a couple of jurisdictions in the United States that
regulate exposure to these chemicals. There is the Environmental Protection
Agency (EPA) and the State of California's Safe Drinking Water
Hello Lou,
You mention that In practice, everyone I know sends Schuko plugs to
Denmark. Well, that is not necessarily true for manufacturers of test and
measurement, and laboratory equipment. I have always specified the Danish
plugs for Denmark without any problems for TM equipment. In fact,
Hello Richard,
I would not want a Class 1 product installed without a protective earth
ground. I know that we have to continuously deal with installations that do
not provide earth grounding but that's the way things are. It is best to
ship products with the appropriate power cord for its
Hello Paul,
I'd say you are okay with just the LVD for general laboratory equipment.
This issue of intended use is very similar to other laboratory equipment
used to analyze blood and urine. However, I would make a statement that the
centrifuges are intended for General Laboratory Use in your
Hello Ned,
Here is a copy of Rule 3:
---
1.3. Rule 3
All non-invasive devices intended for modifying the biological or chemical
composition of blood, other
body liquids or other liquids intended for infusion into the body are in
Class llb, unless the treatment
consists of filtration,
Hello Paul,
EN 61010-2-020: Safety requirements for electrical equipment for
measurement, control, and laboratory use - Particular requirements for
laboratory centrifuges, is covered under the LVD and not the MDD.
Best regards,
Ron Wellman
At 05:11 PM 10/14/2003 -0400, Smith, Paul J. wrote:
Hello Chris,
To get the information you want, you need to get the appropriate
Announcement Bulletins from UL and Information Letters from CSA for the
standards in question. I suggest you contact UL and CSA directly to get
this information because it is normally available as part of the
Hello Peter,
I suggest that you visit the Standards Australia web site and read the
scope of AS/NZS 3123 at:
http://www.standards.com.au/catalogue/script/Details.asp?DocN=AS670712832076
I believe that Note # 7 answers your question.
Best regards,
Ron Wellman
At 02:31 PM 8/1/2003 -0700,
Hello Ian,
You have nothing to worry about in the United States. LEDs are not
considered laser devices in the USA. However, depending on who the
manufacturer of the LEDs is, I would verify with them what information they
have available on standards compliance with their LEDs.
Best regards,
Hello all,
The following document may be dated, but it provides incite into the
applicability of the LVD:
http://www.wbc-europe.com/prodserv/market_segment/low_voltaged73_23.pdf
Best regards,
Ron Wellman
This message is from the IEEE EMC Society Product Safety
Technical Committee emc-pstc
Hello David,
Your issue is not new. I have been in a similar situation where the same
argument was made for a product powered by SELV. However, EN 60950
addresses other safety issues with products other than electrically caused
fire and electrical shock. One needs to also address the
Hello Kevin,
What information are you looking for? Nominal Voltages and Frequency or
certification requirements? From the country list you provide, only two of
them require approval of power cords: Argentina and most recently Brazil. I
suggest that you contact Feller on this because they are
Hello Peter,
This may be similar to the product in question:
http://www.alliedhealth.net/micro_ablation.htm
Best regards,
Ron Wellman
At 10:12 AM 4/9/2003 -0700, Peter L. Tarver wrote:
Nick -
this sounds like one of those electric skin/muscle toner
devices.
While I didn't find specific
Hello Nick,
I'd be curious as to what claims the manufacturer makes for this beauty
treatment product. That may determine one thing in regards to potential
misbranding under FDA regulations but if there are similar devices already
on the market in the USA, I would check to see how they are
Hello Enci,
Even though EMC compliance is regulated around the world the majority of
times that people are found to be non-compliant is from complaints. In most
cases it is competitors blowing the whistle on each other. However, as a
product safety professional I am usually not concerned with
Hello Donald,
I assume you are more interested in the City of San Bernadino rather than
the county. However, based on your message I cannot tell if you are stating
that the City of San Bernadino requires NRTL listing or not. If they do,
and they do not have a localized testing service like
Hello Richard,
Have you taken a look at 21 CFR 1040? The FDA/CDRH has certain compliance
requirements for laser systems and laser products.
Best regards,
Ron Wellman
At 03:16 PM 3/3/2003 -0500, richwo...@tycoint.com wrote:
Are any national restrictions on the use of a Class 2 laser in areas
Hello Jon,
Thanks for the clarification. This helps in understanding which safety
standards may be applied to a medical device based on its intended use.
Therefore, it is very important that we understand what a medical device is
versus medical equipment or laboratory equipment, as they are
-0800, Mike wrote:
My opinion is that unless there are unusual circumstances, an ITE (IEC60950)
certified monitor should satisfy ordinary lab needs. Any dissent?
Mike Harris/Teccom Co./Hayward CA
- Original Message -
From: Ronald R. Wellman rwell...@wellman.com
To: Han, Delphina d
Hello Greg,
I have to disagree with your interpretation. There are many in vitro
devices that are classified as medical equipment and are subject to
pre-market approvals in the US, Japan, and EU. There are strict regulations
on labeling products in the US where even advertising is considered
Hello Delphina,
Laboratory equipment can be considered medical devices if you advertise
them as such or claim that they can be used be physicians to form medical
opinions. However, most laboratory equipment manufacturers get around this
by claiming that their products are intended for
Hello Sam,
I am not familiar with EU requirements for veterinary medical devices.
However, you may want to see what the FDA has to say about them at:
http://www.fda.gov/cvm/index/consumer/regofdevices.htm
Best regards,
Ron Wellman
At 04:01 PM 2/5/2003 -0600, Sam Davis wrote:
All,
I'm trying
Hello all;
I find it inappropriate to bad mouth any company in this forum. Regardless
of who you work or worked for. This forum exists for the exchange of
information related to our profession as EMC and Safety engineers. If you
prefer to continue this thread, do it privately.
Regards,
Ron
This message has been converted via the evaluation version of
Transend Migrator. Use beyond the trial period specified in
your Software Evaluation Agreement is prohibited. Please contact
Transend Corporation at (650) 324-5370 or sales.i...@transend.com
to obtain a license suitable for use in a
Hello Jeffrey,
Try the following:
http://www.ostrans.com/
I have used them extensively in the past to translate many Chinese and
Korean documents into English.
Best regards,
Ron Wellman
At 11:56 PM 1/29/2003 -0800, Collins, Jeffrey wrote:
Group,
Can you recommend a company or individual
Here is what I have:
Total Cross Sectional Area (mm)^2(Brown Sharpe) AWG of single conductor
107.1459
84.9487000
67.433300
53.48210
42.40611
33.62362
26.66743
21.14744
16.76395
13.29936
10.54967
8.36748
6.63269
5.260410
4.172811
3.310312
2.624513
2.081614
1.651315
1.309016
1.038717
0.823518
Hello Doug,
Check out the following standard:
IEC Publication 60173, Colors of the cores of flexible cables and cords.
The color scheme you are looking for is referenced in this standard.
Best regards,
Ron Wellman
At 03:53 PM 1/20/2003 -0700, POWELL, DOUG wrote:
Hello group,
In the past I
Hello Amund,
Unfortunately, your question can be broadly interpreted. As a matter of law
the U.S. has agencies (FCC, FDA) that require product approvals depending
on their intended use and function. Also, the U.S. has environmental laws
that are overseen by the Environmental Protection Agency
Hello Sam,
Chances are if you are ever involved in a product liability law suit in the
United States that the jury will look at you very unfavorably if your
product is not NRTL Listed. Also, expect that the NRTL will not help defend
you in a law suit even if your product is Listed with them.
Hello Peter,
This is probably true when an electrician is involved in a product
installation. However, the majority of products that we are dealing with do
not require an electrician to install. They are either installed by the
Customer or a representative of the product manufacturer. The
Hello Gregg,
Martin is correct that NRTL Listing is not a requirement to sell
electronic products in the U.S. Product usage is something entirely
different and may require compliance under OSHA regulations.
Best regards,
Ron Wellman
At 09:50 AM 1/14/2003 -0500, Gregg Kervill wrote:
Joe,
Hello Peter,
Those of us who have had to list products in the United States already know
this. What is required by law versus what is a customer requirement are two
different things. NRTL listing is a Customer requirement as viewed from a
product manufacturer. However, there are some cities,
or iconic.
My reference to necessity is only to point out that there is something
currently in place that is being used internationally in place of this symbol.
Best regards,
Ron Wellman
At 09:02 PM 1/4/2003 +, John Woodgate wrote:
I read in !emc-pstc that Ronald R. Wellman rwell
Hello Lou and Rich,
Thanks for investigating this. It appears that we are living with a very
old German standard that can be better replaced by using IEC 60529 for
Ingress Protection (IP). Many safety standards are now making reference to
IP numbers, so this for indoor use marking is
You should call a power cord manufacturer to see what they use. Depending
on where your vendor is, I would try Electri-cord for North America, Feller
for Europe, and Volex for the UK and Asia.
At 09:05 AM 12/26/2002 -0500, oover...@lexmark.com wrote:
One of our vendors is looking for test
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