RoHS Directive 2011/65/EU Revision ? Medical Devices - 22nd July 2014

SteveK

Trusted Information Resource
#1
This directive kicks in for medical devices on 22nd July 2014.

e.g. Lead (Pb) < 1,000 ppm by weight of homogeneous material

See:

http://www.eucomed.be/uploads/Modules/Publications/130522_paper_on_rohs_ce_marking.pdf

A number of portable medical devices on the market e.g. suction aspirators, use rechargeable sealed lead acid batteries. Because of this Directive, does it mean that these types of batteries can no longer be used in medical devices? I noticed fairly recently a particular European company switched from lead acid to NiMH ? was this the driver?

Steve
 

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SteveK

Trusted Information Resource
#2
Directive 2006/66/EC on batteries and accumulators has this:

Directive 2002/95/EC (the first RoHS Directive) of the European Parliament and of the Council of 27 January 2003 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (4) does not apply to batteries and accumulators used in electrical and electronic equipment.

In the recast Directive 2011/65/EU it has this statement instead and with its legal-speak I found it initially confusing:

This Directive should apply without prejudice to Union legislation on safety and health requirements and specific Union waste management legislation, in particular Directive 2006/66/EC of the European Parliament and of the Council of 6 September 2006 on batteries and accumulators and waste batteries and accumulators (3) and Regulation (EC) No 850/2004.

So basically I've answered my own question - the recast Directive does not apply to batteries. And what I noted with a particular manufacturer was probably just a coincidence.

Anyway, for Electrical Medical Device manufacturers this recast RoHS Directive potentially is a bit onerous i.e. checking out or testing all device components for RoHS compliance. Thankfully it does not involve Notified Bodies ? they should have no involvement in compliance or otherwise from my reading of the situation. I note however, a number will offer assistance in compliance assessment/testing (obviously for a price). I assume RoHS is policed. The enforcing agency in the UK would appear to be The National Measurement Office. How do they go about this in practice?

I've started going through the RoHS, REACH, ELV, IMDS and Restricted Substances Related Regulations threads to try and glean some already posted info. in an attempt to answer my own question again!

Steve :bonk:
 

Ronen E

Problem Solver
Staff member
Moderator
#3
Steve, I have 2 comments:

1. The CE marking provisions apply when a device is "Placed on the Market" or "Put into Service". This means that a device already in use (e.g. the one you gave as an example, with the lead acid battery) should not be affected. Only units placed on the market for the first time should be in compliance with new CE marking provisions (even if they are of a design that predates such provisions).

2. Notified Bodies are required to ascertain that the devices they oversee meet the Essential Requirements, including safety and health requirements that hazardous materials would definitely come under, according to "The State of the Art". I'm quite sure that the RoHS recast will be considered "State of the Art" in the EC. Thus, it seems to me likely, and also quite reasonable, that NB will oversee RoHS II compliance even though they were not directly granted powers in that regard.

Cheers,
Ronen.
 
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M

medgar

#4
Hi Ronan
I think that's a fair observation. Any thoughts on how the TGA (wearing their NB hat) may look at RoHS for Australian made medical devices CE marked under the MRA with Europe ... If at all?
 

CharlieUK

Quite Involved in Discussions
#5
Your MD Notified Body is not is a position to issue an opinion on the RoHS Directive.

There aren't any NBs appointed for RoHS (http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseaction=directive.main ).

NBs can only issue opinions on directives against which they have been appointed. And in the case of certain directives, such as R&TTE, may only be asked to give opinion against certain, specific articles, and not against others if so requested by the manufacturer.

Charlie
 
R

redknight07

#7
Scope of the recast RoHS directive when compliance of components are considered seems quite complex to me. After reading several guidelines regarding this issue, I am confused as to how to interpret the following texts correctly.

One such article explaining the directive states that:

"Components, spare parts or unfinished products, as far as they do not fall under the definition of EEE are not considered EEE. Thus they don’t fall under the RoHS scope.."

So I would interpret that for components that are not an integral part of the equipment such as dummy weights with no electrical function used only for calibration and quality checks or straps made of nylon/some other material used to hold patient or software provided in a disk will not require compliance.

It then follows up with the following statements:

"Nonetheless components destined to be integrated/installed into equipment falling into RoHS scope have to comply with substance restrictions, independent of the fact whether they constitute an EEE or not.
and
Do components have to comply with RoHS 2?
RoHS 2 provides that EEE has to meet the requirements of the Directive. Since equipment consists of different components, the EEE itself can only meet the substance requirements if all its components and parts meet the substance restriction requirements of RoHS 2, including non-electronic or non-electric components like fasteners or the plastic case of a desktop computer. Therefore components being used in finished EEE or for repair or upgrade of used EEE, which is in the scope of RoHS 2 must meet the substance restrictions according to Art. 4 but do not need CE marking. Components sold as a stand-alone components or if produced to be used in a product benefiting from an exclusion do not have to be CE marked and do not have to comply with the substance requirements.”


I’m not sure if I am interpreting this correctly but I would believe that for components (non-EE) that are not contributing to the intended function of the equipment, they do not need to be in compliance. Am I correct in this assumption?

Would really appreciate your comments. Thanks.
Aniket
 
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#8
Dear all,

the ROHS2 directive is going to apply to all EEE once the transition period for all 11 categories (the last one ends June 2019) is over.

The ROHS2 directive has to be applied to all components of the final EEE that is placed on the market in the way that the restrictions for the prohibited substances are defined as per cent per weight of the final product. That is, if your final product has a weight of 1 KG for example then all parts together must not contain more than 1g of lead or mercury or 0,1g cadmium or ... et cetera.

The only exceptions to the given boundary values are listed in appendix 3.

The CE marking on the device also states that the corresponding device is in compliance with the ROHS2 directive. Additional it is compulsory to create a corresponding declaration of conformity.

The standard EN ISO 50581 gives technical background how to proof the compliance with ROHS2. Most often certain tests and their documentation is adequate to proof this.

The directive applies only when products are placed on the market as Ronen said allready. But I want to stress that an older design of a device has to be reworked to comply with ROHS2 as soon as the directive and the corresponding transition rate for the product category has expired.

I hope my explanations helped a little. For any further questions please feel free to contact me.
 
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Mark Meer

Trusted Information Resource
#9
The ROHS2 directive has to be applied to all components of the final EEE that is placed on the market in the way that the restrictions for the prohibited substances are defined as per cent per weight of the final product. That is, if your final product has a weight of 1 KG for example then all parts together must not contain more than 1g of lead or mercury or 0,1g cadmium or ... et cetera.
I don't know that this is correct.

The Directive speaks of "homogeneous" materials, which seems to imply that each homogeneous component must itself be RoHS compliant.

For example, if the entire device weighed 1kg, and contained no lead but for a single 1g screw that had 0.5g of lead, this device would be non-compliant (because the screw is a homogeneous component that is non-compliant).
 
R

redknight07

#10
Correct. The directive defines homogeneous material’ as one material of uniform composition throughout or a material, consisting of a combination of materials, that cannot be disjointed or separated into different materials by mechanical actions such as unscrewing, cutting, crushing, grinding and abrasive processes;

The screw needs to be compliant by itself and not in combination with the equipment. Thanks, Mark.
 
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