Am I good to claim RoHS for my product? Solder Content

somashekar

Staff member
Super Moderator
#1
Its a medical device weighing 25gms, and has just 2 solder points. All parts of the device are RoHS claimed. However the solder I use is 63/37 tin lead. With this, the lead content in the device weighs far less than the permissible limit for lead per the RoHS. Am I good to claim RoHS for my device using the 63/37solder.
 
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Randy

Super Moderator
#2
Re: Am I good to claim RoHS for my product.

You know, I just looked at a huge RoHS program today, so if you are sure that you are below the permissible levels you may be OK as is, but I'd recommend X-Ray qualitative and Ion Chromagraphic quantitative testing so that you can have some verifiable data on hand to support your claim.

Just because the solder is labeled 63/37 doesn't make it so.
 

Kales Veggie

People: The Vital Few
#3
Re: Am I good to claim RoHS for my product.

Its a medical device weighing 25gms, and has just 2 solder points. All parts of the device are RoHS claimed. However the solder I use is 63/37 tin lead. With this, the lead content in the device weighs far less than the permissible limit for lead per the RoHS. Am I good to claim RoHS for my device using the 63/37solder.
No, you cannot. 63/37 solder contains 37% Pb, which violates the rules.

Why not use a Pb free solder? (yes, you have to revalidate)
 

somashekar

Staff member
Super Moderator
#4
Re: Am I good to claim RoHS for my product.

No, you cannot. 63/37 solder contains 37% Pb, which violates the rules.

Why not use a Pb free solder? (yes, you have to revalidate)
The process to use leadfree solder resulted in some internal variations of chip bonding in the small devices that we solder wires to.
Though the 63/37 violates, the weight of lead as a pecentage to the weight of device meets and is lesser than regulation.
Here can I be good for RoHS with a quantitative testing by weight
OR
Does the RoHS directive provide me avenue to claim excemption with due justification.
 

Kales Veggie

People: The Vital Few
#5
Re: Am I good to claim RoHS for my product.

The process to use leadfree solder resulted in some internal variations of chip bonding in the small devices that we solder wires to.
Though the 63/37 violates, the weight of lead as a pecentage to the weight of device meets and is lesser than regulation.
Here can I be good for RoHS with a quantitative testing by weight
OR
Does the RoHS directive provide me avenue to claim excemption with due justification.
RoHS (and ELV) calculate compliance % of material weight, not % of the part weight.

You would have to review all the exemptions under RoHS Recast to determine if one of them applies:

http://www.foresitesystems.com/pdfs/RoHSExemptionsRevisionWhitepaper.pdf
 

Randy

Super Moderator
#6
We covered the exemptions and what you described about your reasoning might be OK, but the testing to support yourself would be the best route.

And as suggested try lead free or even lower lead, there are different types for a variety of applications
 
#7
Dear Somashekar,

The RoHS requirement is applied to any part/section that can be physically removed from the product. The solder can be removed from your device by de-soldering or even by filing. Hence using a 37 % lead containing solder will make your product RoHS non-compliant.

With kind regards,

Ramakrishnan
 

Mikishots

Trusted Information Resource
#8
Its a medical device weighing 25gms, and has just 2 solder points. All parts of the device are RoHS claimed. However the solder I use is 63/37 tin lead. With this, the lead content in the device weighs far less than the permissible limit for lead per the RoHS. Am I good to claim RoHS for my device using the 63/37solder.
The rule is that the banned substance content can't exceed the stated limit in any homogenous part of the product that can be mechanically separated. If that solder can be chipped, ground, filed off the card and is found to contain more than the currently specified limit of lead, the product is non-compliant.
 

somashekar

Staff member
Super Moderator
#9
(18) Exemptions from the substitution requirement should be permitted if substitution is not possible from the scientific and technical point of view, taking specific account of the situation of SMEs or if the negative environmental, health and consumer safety impacts caused by substitution are likely to outweigh the environmental, health and consumer safety benefits of the substitution or the reliability of substitutes is not ensured. The decision on exemptions and on the duration of possible exemptions should take into account the availability of substitutes and the socioeconomic impact of substitution. Life-cycle thinking on the overall impacts of exemptions should apply, where relevant. Substitution of the hazardous substances in EEE should also be carried out in such a way as to be compatible with the health and safety of users of EEE. The placing on the market of medical devices requires a conformity assessment procedure, according to Council Directive 93/42/EEC of 14 June 1993 concerning medical devices ( 1 ) and Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices ( 2 ), which could require the involvement of a notified body designated by competent authorities of Member States. If such a notified body certifies that the safety of the potential substitute for the intended use in medical devices or in vitro diagnostic medical devices is not demonstrated, the use of that potential substitute will be deemed to have clear negative socioeconomic, health and consumer safety impacts. It should be possible, from the date of entry into force of this Directive, to apply for exemptions for equipment, even before the actual inclusion of that equipment in the scope of this Directive.
Any medical device people plan claiming / have claimed exemption via this route ? Can you share your action plan and NB response to this...
 
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