European Union Environmental Product Directives ELV, WEEE/ RoHS

[Eamon]

WEEE and medical devices

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

 

[David Hartman]

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!

 

[Al Rosen]

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?

 

[David Hartman]

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!

 

[dbulak]

Amounts allowable and forbidden.

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?

 

[Al Rosen]

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.

 

[greta]

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