RoHS Medical Devices: Application to Accessories, Components and Non-EE parts

R

redknight07

#1
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. Apologies for starting a new thread if there are similar discussions ongoing.

Aniket
 
Elsmar Forum Sponsor

Mark Meer

Trusted Information Resource
#2
What guidance document are you quoting from?

I'm pretty certain components & spare parts are included (at least those to be put in medical electrical devices after July 22, 1014).

Keep in mind the intent of the Directive: to protect health and the environment.

If a "dummy weight" is part of the device, even if it has no electrical function, it should be considered, as it will be ultimately be disposed along with the rest of the device...
 
R

redknight07

#3
What guidance document are you quoting from?

I'm pretty certain components & spare parts are included (at least those to be put in medical electrical devices after July 22, 1014).

Keep in mind the intent of the Directive: to protect health and the environment.

If a "dummy weight" is part of the device, even if it has no electrical function, it should be considered, as it will be ultimately be disposed along with the rest of the device...

I quoted from this document: http://www.eucomed.org/uploads/Modules/Publications/joint-rohs-faqs_2014_02_28_pub.pdf

Question 9 on Page 5.

Regarding the dummy weights, in the Recast RoHS directive, Annex IV "Applications exempted..." point 13. Lead in counterweights.

So if the dummy weight contained only lead from amongst the restricted substance list, it would be exempted? If counterweights is a substitute for dummy weights.

Thank you for your response, Mark.
 
R

redknight07

#4
Also, if the equipment involved installing a software through a CD, then would this crazy directive apply to the CD and its case? This is a really stupid question.
 

Mark Meer

Trusted Information Resource
#5
Regarding the dummy weights, in the Recast RoHS directive, Annex IV "Applications exempted..." point 13. Lead in counterweights.
Good point. A weight is probably a bad example...

It appears that Annex IV is a list of applications which, due to technological or economic reasons, might require restricted substance content above those in Annex II.

Annex IV applications aside, my take is:
1. For most electronic components, suppliers are willing to provide RoHS compliance statements and/or test-reports.

2. Components that might be suspected to possibly contain non-compliant levels and for which suppliers cannot demonstrate compliance, you will have to either test the component yourself, or look into other solutions or suppliers. From Wikipedia examples of items to consider include:
  • paints and pigments
  • PVC (vinyl) cables as a stabilizer (e.g., power cords, USB cables)
  • solders
  • printed circuit board finishes, leads, internal and external interconnects
  • glass in television and photographic products (e.g., CRT television screens and camera lenses)
  • metal parts
  • lamps and bulbs

3. For "common" materials (paper, fabrics, etc.) you can probably be reasonably certain they don't contain excess amounts of hazardous substances...
 
R

redknight07

#6
There seems to be plenty of grey areas in the interpretation.

According to the guidance document available on the Eu webpage: http://ec.europa.eu/environment/waste/rohs_eee/pdf/faq.pdf

refer page 20

For the example of a wardrobe with lights, even if sold as a single unit, a distinction between the piece of furniture and the electric/electronic device the piece is or can be equipped with has to be drawn. If the lighting is EEE in itself and both the lighting and the wardrobe can be separated and used as fully functional separate products, only the electric/electronic equipment (the lighting) is in the RoHS 2 scope. The furniture itself would then be outside the scope.


This would mean that something like dummy weights would fall out of the scope of the directive. It then goes on to say that:

This scenario is different from the example of power tools, lamps and many other types of EEE, most of which are already in the scope of RoHS 1 and are comprised of various detachable electric/electronic and non-electric/electronic parts, which are however only fully functional in combination. These parts are simply integral parts of EEE and have to meet the respective requirements. This is for example reflected in various existing exemptions for non-electric EEE parts.

This could be interpreted that only non-electronic components that are attached to the equipment and help form the main body of the final equipment need to be RoHS compliant which is understandable since the equipment will not be in compliance unless its parts are in compliance. How would this be applied to the case of weights then? They are not attached to the equipment body.

It did answer my previous question regarding compact disks, they are outside the scope of RoHS 2.


Regarding the use of straps to hold patient in place, it can be considered as consumables since after time it gets worn out and needs to be replaced and hence is not within scope of RoHS 2. (Addressed in Q 7.4 in the document.)

Phew!!!
 
Last edited by a moderator:
R

redknight07

#7
According to the guidance document available on the Eu webpage: http://ec.europa.eu/environment/waste/rohs_eee/pdf/faq.pdf

refer page 20

For the example of a wardrobe with lights, even if sold as a single unit, a distinction between the piece of furniture and the electric/electronic device the piece is or can be equipped with has to be drawn. If the lighting is EEE in itself and both the lighting and the wardrobe can be separated and used as fully functional separate products, only the electric/electronic equipment (the lighting) is in the RoHS 2 scope. The furniture itself would then be outside the scope.


This would mean that something like dummy weights would fall out of the scope of the directive. It then goes on to say that:
Instead of using the quoted text above to prove exemption for weights, it can be argued that they are a stand-alone component.

The article states that
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.


Stand-alone component is defined as a component that is sufficient in itself to perform its intended function, without the need of any other device, component, or service;... so weights could be considered in this category.



So hopefully this sounds like a logical conclusion to exempt the weights form the directive. Any comments?


Thanks,
Aniket
 
R

redknight07

#8
Greetings,

1. Is there a requirement that the MDD Technical File and the RoHS2 Tech Documentation be separate files and must not be combined?!
2. Does this same requirement apply to the DoC's as well, i.e. the RoHS 2 DoC to be totally independent of the MDD DoC?!

This sounds a really absurd requirement to have separate tech files and DoCs just to document compliance to RoHS 2. I was assuming that the latest Tech File would be updated to add references of the RoHS 2 standard wherever required in the list of standards and in the Essential Requirements Checklist.

And for the Declaration of Conformity, which would include a reference of the electrical safety and EMC standards along with other standards to which the product is tested, will include a statement that the device is conforming to the requirements of the RoHS 2 directive 2011/65/EU as well.


The two questions that I asked were communicated to us by our Authorized Representative under updates. I do not believe that such a requirement to have these documents completely independent is explicitly stated in the EN 50581:2012. Please help.
 

Mark Meer

Trusted Information Resource
#9
I'm no authority, but I can throw in my 2 cents...

1. Is there a requirement that the MDD Technical File and the RoHS2 Tech Documentation be separate files and must not be combined?!
I'd be astounded if there was. In all the regulations and standards I've read, I don't think I've ever seen an explicit requirement for "separate files".

Regulations and standards are more concerned with documented content, and don't generally prescribe how you should organize/divide your documentation.

2. Does this same requirement apply to the DoC's as well, i.e. the RoHS 2 DoC to be totally independent of the MDD DoC?!
These should probably be separate, as they are declarations of conformity to 2 separate directives. Shouldn't be a big deal, as these are pretty boiler-plate...

Also, if you are supplying components to customers who manufacture electronics, they might ask for an RoHS DoC.
 
R

redknight07

#10
Thank you for your response, Mark.

I was surprised too when I was heard regarding having separate Tech Files since within the RoHS 2 Directive Article 7 (c) it is mentioned that a single tech documentation may be drawn up. And I agree than drawing up a separate DoC for RoHS would be straightforward. Yes, suppliers for components and accessories would require a DoC. We had to seek that for most of the components that we purchase.
 
Thread starter Similar threads Forum Replies Date
D The Status of ROHS for Medical Devices - April 2019 REACH and RoHS Conversations 3
SteveK RoHS Conformity Risk Assessment - Medical Devices RoHS, REACH, ELV, IMDS and Restricted Substances 2
SteveK RoHS Directive 2011/65/EU Revision ? Medical Devices - 22nd July 2014 CE Marking (Conformité Européene) / CB Scheme 30
M RoHS CE Mark - Medical Devices built for US before 22 July 2014 ISO 13485:2016 - Medical Device Quality Management Systems 3
S What needs to be done to demonstrate RoHS compliance for Medical Devices? RoHS, REACH, ELV, IMDS and Restricted Substances 6
R RoHS for Medical Devices - Does the directive apply to non-EEE accessories? RoHS, REACH, ELV, IMDS and Restricted Substances 1
C Legacy Medical Devices -- RoHS compliance in 2014 or 2019? RoHS, REACH, ELV, IMDS and Restricted Substances 5
M RoHS (or similar) Requirements for Medical Devices in the World Other Medical Device Regulations World-Wide 4
M RoHS (or similar) Requirements for Medical Devices in the World RoHS, REACH, ELV, IMDS and Restricted Substances 8
E RoHS for Medical Devices in the EU (European Union) EU Medical Device Regulations 6
Steve McQuality RoHS for Medical Devices - "Medical Device Exception" RoHS, REACH, ELV, IMDS and Restricted Substances 2
B Query on Medical Device Electronics RoHS Certificate Statement RoHS, REACH, ELV, IMDS and Restricted Substances 3
D ROHS 2 - Medical Device: Placing vs Making Available on the market EU Medical Device Regulations 3
A ROHS and CE Mark - Requirements for a Class IIa Medical Device EU Medical Device Regulations 6
M RoHS for Disposable Medical Device Assemblies RoHS, REACH, ELV, IMDS and Restricted Substances 1
D ROHS regulation for Refurbuished Medical Units EU Medical Device Regulations 2
B RoHS Compliance for a Medical Device Manufacturer RoHS, REACH, ELV, IMDS and Restricted Substances 12
K RoHS in Hong Kong - Department of Health, Medical Device Control Office (MDCO) RoHS, REACH, ELV, IMDS and Restricted Substances 6
M Informational RoHS Standard - EN 63000:2018 to replace EN 50581:2012 Medical Device and FDA Regulations and Standards News 11
R ROHS Exemption Declarations REACH and RoHS Conversations 5
M ROHS : Applicability for AIMDs RoHS, REACH, ELV, IMDS and Restricted Substances 2
J Where can I find the latest update to Reach and ROHS? REACH and RoHS Conversations 7
padraick63 REACH and ROHS Requirement for a Molded Part REACH and RoHS Conversations 1
R Certificate of compliance to RoHS/REACH/WEEE - any such animal? REACH and RoHS Conversations 18
T China ROHS exemptions - Are there any exemptions for ROHS 2 China? REACH and RoHS Conversations 0
Ed Panek CE REP questions about our devices ROHS compliance REACH and RoHS Conversations 1
R REACH and ROHS compliance for hundreds of parts made over 25 years REACH and RoHS Conversations 3
S Prop 65 and RoHS statement REACH and RoHS Conversations 6
J What my companies RoHS declaration should say 2011/65/EU, 2015/863, or 2017/2102 REACH and RoHS Conversations 3
bio_subbu EU Publishes New DIRECTIVE (EU) 2017/2102 AMENDING 2011/65/EU ON ROHS-2 REACH and RoHS Conversations 0
T CE Marking & Compliance to MDD, EMC, RoHS, and GPSD REACH and RoHS Conversations 4
D How do I show compliance to RoHS, REACH and Conflict Minerals? REACH and RoHS Conversations 6
J RoHS, WEEE and REACH Consulting Expertise Needed REACH and RoHS Conversations 4
P Necessary Compliance Documentation for RoHS and REACH REACH and RoHS Conversations 5
Q Guidance regarding Legally Refurbishing a Non-RoHS Instrument in the EU REACH and RoHS Conversations 1
M ROHS & REACH in TEFLON Material - NABL Testing Laboratories REACH and RoHS Conversations 1
S Sell a Non-RoHS device, manufactured before RoHs regulations became effective? EU Medical Device Regulations 2
Q EU ROHS and GUI Usability Trial Requirements EU Medical Device Regulations 10
M RoHS Directive - Supplier Compliance - Declaration of Conformance CE Marking (Conformité Européene) / CB Scheme 12
dubrizo Who handles Your Reach, RoHS, 3TG Compliance RoHS, REACH, ELV, IMDS and Restricted Substances 9
smryan Compliance Officer Outsourcing? RoHS, REACH, ELV, GADSL, IECSC Other ISO and International Standards and European Regulations 5
B RoHS Directive 2014/5/EU Leaded Solder Exemption RoHS, REACH, ELV, IMDS and Restricted Substances 2
bio_subbu Official Journal of EU published two new RoHS Exemptions EU Medical Device Regulations 1
A RoHS compliance - Our market is non EU countries only ISO 13485:2016 - Medical Device Quality Management Systems 4
D Will A Few Failed Solder Joints Make Me RoHS Non Compliant? RoHS, REACH, ELV, IMDS and Restricted Substances 9
L IOS-MAT-0010 vs REACH/ROHS RoHS, REACH, ELV, IMDS and Restricted Substances 2
P Must all parts of a product be RoHS compliant? EU Medical Device Regulations 5
N RoHS Compliance requirement for Hexavalent Chromium RoHS, REACH, ELV, IMDS and Restricted Substances 6
R RoHS Compliance Problem with One Component RoHS, REACH, ELV, IMDS and Restricted Substances 5
J RoHS Components with Lead Exemptions (Capacitors on a PCB) RoHS, REACH, ELV, IMDS and Restricted Substances 11
Similar threads


















































Top Bottom