Hello,

I was interested in finding out if suppliers in the electronics sector are being hit with the requests to either provide material content disclosure (giving the full chemical breakdown of the components or materials they supply) or provide a certification statement that they are compliant with the European Union's Restriction of Hazardous Substances in Electrical and Electronic Equipment.

The auto manufacturers chose to collect complete material and chemical disclosure through an electronic database (the International Material Data System, IMDS) in order to deal the End of Life Vehicle Directive. Now it will be interesting to see what happens with the electronics companies as they prepare to deal with the RoHS and WEEE Directives.

If anyone has any information on requests that have been floating around I would really appreciate it.

Thanks,

Chris Harden

It’s probably not related but we were recently asked (required) by one customer to disclose the domestic content of our electronic assemblies, including detail regarding any components or subassemblies procured from foreign sources. We are taking exception to the requirement due to the tedious nature of the task. We buy hundreds of “spec-control” components from distributors. We could flow the requirement down to the distributors but they would just tell us to buzz off for the same reasons.

I hear rumblings regarding end-of-life concerns from time to time, especially as they relate to lead solder in electronic assemblies and the EEU. I am not up to date on the details though so I won’t step out on a limb by opening my mouth. LOL!

IN my cyber-travels on this subject, the answer is YES to your request. EXCEPT....they decided to develop their own infracture in data collection and not utilize EDS'...cannot locate the exact article and web site at this time. When I use the term "electronics", I am including the computer industry. Also, my company just received notice that GE (household appliances) will be submitting IMDS - the office furniture industry has been doing it for 2 years now as well the automotive.

:2cents:

IN my cyber-travels on this subject, the answer is YES to your request. EXCEPT....they decided to develop their own infracture in data collection and not utilize EDS'...cannot locate the exact article and web site at this time. When I use the term "electronics", I am including the computer industry. Also, my company just received notice that GE (household appliances) will be submitting IMDS - the office furniture industry has been doing it for 2 years now as well the automotive.

:2cents:
I too have been spending alot of time on this subject. I found a web site that explain the entire history of this evolutution of WEEE and RoHS. It is www.goodbyechain.com. Hope this can give some info. Also, I checked out by Google seach WEEE and RoHS and there is alot of info there.

Excellent web site! I was very impressed with their indepth information....thank you for the input... :cool:

I thought you might be interested to know in addition to the information Goodbye Chain has we have put information on our website at www.mdsmap.com. We have fact sheets on ELV, WEEE/RoHS, EuP, and REACH.

Still interested in hearing what people are being hit with concerning information requests.

Thanks,

Chris Harden

I thought you might be interested to know in addition to the information Goodbye Chain has we have put information on our website at www.mdsmap.com. We have fact sheets on ELV, WEEE/RoHS, EuP, and REACH.

Still interested in hearing what people are being hit with concerning information requests.

Thanks,

Chris Harden
I have had about 25 companies ask about the WEEE and RoHS directives. We still are not sure as to the response we are to give. We are trying to gather as much info as possible before we answer. Besides the web sites mentioned in this thread, are there any experts that can offer advice-answer questions? Should Marc set up a special listing for this like he does for ISO?

In answer to your question, "Are there any WEEE/ RoHS experts?" I would have to say yes. Obviously WEEE and RoHS are new directives and this type of legislation is fairly new, my organization, MDSMap has been working in this field for four years now. Are initial work focused on the ELV Directive which set the same requirements for the auto industry that WEEE/ RoHS does for electronics. If we can help you in anyway please feel free to contact us at 734 213-5088 or info@mdsmap.com.

Also I might mention there are various groups working on helping the electronics industry with WEEE/ RoHS the most active in North America is the National Electronics Manufacturing Initiative (NEMI). NEMI hosts a weekly conference call on RoHS reporting Tuesdays at 1:00 PM (EST). You may want to visit their website www.nemi.org. IPC also has information available and has launched a lead free website.

The National Electronics Distributors Association (NEDA) has a conference in January on RoHS their website is www.nedassoc.org.

Good Luck and let me know if I can help.

Chris Harden

With all these directives, I wonder if we can have a standard to follow to make things a bit more uniform? I am most familiar with the requirements of the big three but am rapidly learning about other tier one and two requirements as well.

IN my cyber-travels on this subject, the answer is YES to your request. EXCEPT....they decided to develop their own infracture in data collection and not utilize EDS'...cannot locate the exact article and web site at this time. When I use the term "electronics", I am including the computer industry. Also, my company just received notice that GE (household appliances) will be submitting IMDS - the office furniture industry has been doing it for 2 years now as well the automotive.

:2cents:

I know what you mean about others creating their own databases instead of using the IMDS. I have to go to Honda next month for such training on their reporting requirements using their database.

For those who have been at the Honda Training, how did it go? How did their system compare to IMDS? How happy are you about having to learn another system?


Also I was curious has anyone received any requests to submit material content information in IMDS for non-automotive parts? Someone mentioned GE appliance doing this which is a surprise.

Any information is appreciated.

Thanks,

Chris Harden

I have been reading through the WEEE and ROHS directive. I am however not clear about the medical devices being imported into Europe. Does the ROHS start for electronic medical devices after July 1, 2006?

What about the August 13, 2005 deadline? Would medical device manufacturers also be required to come up for the recovery after this deadline? Medical devices fall under category 8 and this category is excluded in ROHS.

Can somebody help me?

Thanks

I have been reading through the WEEE and ROHS directive. I am however not clear about the medical devices being imported into Europe. Does the ROHS start for electronic medical devices after July 1, 2006?

What about the August 13, 2005 deadline? Would medical device manufacturers also be required to come up for the recovery after this deadline? Medical devices fall under category 8 and this category is excluded in ROHS.

Can somebody help me?

ThanksMD are exempt as far as I understand. This is to be reviewed every 3 years. I believe that it was reviewed within the last two months, but I haven't heard anything.

Hello,

Medical devices are currently exempt from the RoHS Directive, in fact they do not have a recycling target under the WEEE Directive yet. They are to be reviewed at two year intervals to determine at what point they will be added. If I were to make a prediction based on what I have seen with similar legislation I would bet it will be five years or longer before they even get around to dealing with medical devices from an RoHS.

Al, thanks for your response.

WEEE states the following for category 8 (medical devices)

4. The European Parliament and the Council, acting on a
proposal from the Commission, shall establish new targets for
recovery and reuse/recycling, including for the reuse of whole
appliances as appropriate, and for the products falling under
category 8 of Annex IA, by 31 December 2008. This shall be
done with account being taken of the environmental benefits
of electrical and electronic equipment in use, such as improved
resource efficiency resulting from developments in the areas of
materials and technology. Technical progress in reuse, recovery
and recycling, products and materials, and the experience
gained by the Member States and the industry, shall also be
taken into account.


ROHS states:

1. Without prejudice to Article 6, this Directive shall apply
to electrical and electronic equipment falling under the categories
1, 2, 3, 4, 5, 6, 7 and 10 set out in Annex IA to Directive
No 2002/96/EC (WEEE) and to electric light bulbs, and
luminaires in households.

As category 8 is for medical devices, would it mean that ROHS is not applicable for medical devices?

Summarizing it would appear that medical devices are exempt from ROHS and according to WEEE new targets for recovery/reuse would be set up for medical devices by December 1, 2008.


Would somebody else from medical device industry shed additional light on these directives.

Thanks

Thanks, Chris, for your inputs.

Amjadrana,

You are correct about medical devices being exempt from RoHS as they are catagory 8 in WEEE. They may be incorporated into RoHS later as you can see by Article 6 of the RoHS Directive:

In particular the Commission shall by that date (13 February 2005) present proposals for including in the scope of this Directive equipment which falls under categories 8 and 9 set out in Annex IA to Directive 2002/96/EC (WEEE).

Basically this section states that the European Commission shall at regular intervals (starting 2/13/05) consider including medical and control equipment in the RoHS Directive. If I had to guess I would estimate that in the next 3-5 years an update to RoHS would include catagory 8 substances and that when they are included in the directive they will probably receive 3-5 year of warning. What I mean is expect maybe by 2008 to 2010 for medical equipment to be included but this inclusion probably won't take effect to 2012 to 2015.

On a side note were you aware that the California Medical Association adopted language in I believe 2003 that strongly suggested its member adopt requirements for the electronic equipment they purchase regarding take back and the presence of hazardous constiuents? If is quite possible you may see other drivers effect electronic equipment before WEEE or RoHS.

Look up my contact information in I can be of help.

Thanks,

Chris Harden
MDSMap

Thank you, Chris,

I will get back to you in due course of time. I have contacted our European Representative as well to shed more light on the applicability of these directives to medical devices.

How does RoHS apply to this situation? We get material in from our suppliers. All we do is cut it to size for customers. We do not make any parts what so ever. Nor do we change the material or its chemical composition or add anything to the material. My question is, what sort of statement should we make letting our customers know as far as being Rohs compliant?

Hi,
From what you are saying, you don't do much with the materials except put your name on them, change the size (and weight) and supply them to your customer. If this is correct, it is my understanding that you are responsible for making sure that material is compliant since it is your company's name on the supplied materials. At least that's the way my understanding is. Hope this helps.

Hi. I've been following the discussion about medical devices, and I wanted to ask for a clarification on a few points, from whoever might be able to enlighten me.

1. Are there additional details available beyond what I have in hand regarding WEEE (Directive 2002/96/EC of the European Parliament ... 27 January 2003 on WEEE)? This directive makes references to further details and regulations to be enacted by member states.

2. Even if RoHS is kicking in a good deal later for medical devices, are there any WEEE requirements that kick in in in August for medical devices? How about the basic WEEE symbol (crossed out dumpster) labeling requirement? Anything else?

3. In WEEE, what does "products put on the market after 13 August 2005" mean? I assume this means any goods sold after this date. It does not mean a product introduced after this date, does it (i.e. grandfathering products introduced earlier)?

4. What sort of financial arrangement is contemplated in Articles 8 and 9 (Financing in respect of WEEE ... private households and other than...)? Is this left up to each memeber state (creating a confusion of different arrangements)?

Many thanks in advance to anyone who can help me out or at least point me in the right direction.

Eamon Egan

Amjadrana,

You are correct about medical devices being exempt from RoHS as they are catagory 8 in WEEE. They may be incorporated into RoHS later as you can see by Article 6 of the RoHS Directive:

In particular the Commission shall by that date (13 February 2005) present proposals for including in the scope of this Directive equipment which falls under categories 8 and 9 set out in Annex IA to Directive 2002/96/EC (WEEE).

Basically this section states that the European Commission shall at regular intervals (starting 2/13/05) consider including medical and control equipment in the RoHS Directive. If I had to guess I would estimate that in the next 3-5 years an update to RoHS would include catagory 8 substances and that when they are included in the directive they will probably receive 3-5 year of warning. What I mean is expect maybe by 2008 to 2010 for medical equipment to be included but this inclusion probably won't take effect to 2012 to 2015.

On a side note were you aware that the California Medical Association adopted language in I believe 2003 that strongly suggested its member adopt requirements for the electronic equipment they purchase regarding take back and the presence of hazardous constiuents? If is quite possible you may see other drivers effect electronic equipment before WEEE or RoHS.

Look up my contact information in I can be of help.

Thanks,

Chris Harden
MDSMap

One concern that manufacturers of electronic medical devices should give consideration to is the fact that many of the electronic components they are currently receiving/using may in-fact be ROHS compliant (i.e. no longer Sn/Pb tinned). Will this fact impact your current soldering processes and/or the reliability of the solder joints in products you are currently providing?

Just food for thought!

One concern that manufacturers of electronic medical devices should give consideration to is the fact that many of the electronic components they are currently receiving/using may in-fact be ROHS compliant (i.e. no longer Sn/Pb tinned). Will this fact impact your current soldering processes and/or the reliability of the solder joints in products you are currently providing?

Just food for thought!Dave, you make an excellent point. It is one that has been a concern of mine. I would like to develop a survey addressing this issue for our suppliers to complete. I would like to know if someone else is considering or has already done this?

Dave, you make an excellent point. It is one that has been a concern of mine. I would like to develop a survey addressing this issue for our suppliers to complete. I would like to know if someone else is considering or has already done this?

Many distributers are already making inroads into the development of this type of matrix and if you contact them you should find them willing to provide this information. One of our biggest distributers (Future) has provided us with a list of those devices that we currently buy that are already ROHS compliant (free of charge).

Just to elevate the awareness level a bit more: Many of the manufacturers are making these changes without changing their part numbers; almost as many are releasing ROHS compliant components with new part numbers, but are not specifically advertising their availability; and some are taking the stand that based on the overall weight of their provided component (large chokes as an example) their current use of 50/50 Sn/Pb meets ROHS compliancy requirements.

Caveate emptor!

I have been looking over the RoHS info in the threads. does anyone know where I can get the amounts of allowable substances and the substances that are banned? Is there such a list and where can I find it?

I have been looking over the RoHS info in the threads. does anyone know where I can get the amounts of allowable substances and the substances that are banned? Is there such a list and where can I find it?I think you can find it in the attached document.

One concern that manufacturers of electronic medical devices should give consideration to is the fact that many of the electronic components they are currently receiving/using may in-fact be ROHS compliant (i.e. no longer Sn/Pb tinned). Will this fact impact your current soldering processes and/or the reliability of the solder joints in products you are currently providing?

Just food for thought!

This is the $1,000,000 thought. If the components are lead-free, how does it affect the soldering process? The Internet is full of very informative sites that offer standards, processes that work and forums. What substances work well with lead-free solder providing reliability and what does not? These are questions that have been widely investigated. From what I know, lead-free components and lead-free solder DO affect reliability of the solder joints in that they can be just as reliable and durable. The key is to have all components lead-free first. The scary thing is that many suppliers have already changed to Pb free and do not tell the customer. This scenario may cause intermittent issues with the PCB through contamination.

Thanks