Medical devices regulation regarding types of flux

[IanTrout]

Hi all,

I have a small regulation question regarding production of medical devices:
Is there a definition somewhere of what types of flux can and cannot be used in medical devices?

I know that the solder wire should always be RoHS, but this is a more general regulation and not medical devices specific,
but is there something in the books about flux?


Thanks in advance,
Trout

 

[ZASto]

I know that the solder wire should always be RoHS, but this is a more general regulation and not medical devices specific,
but is there something in the books about flux?

Medical devices should not be RoHS compliant, as well as the motion controllers and automotive/avionic electronics.

As for flux, that is something that is inside of the device, can not be ingested and does hot come in contact with skin. :smile:

 

[IanTrout]

Thanks, this helps a lot!

One question though - what do you mean that medical devices don't need RoHS?
The EU requires every electronic device to be RoHS compliant, and the US has started this in all states beginning from 2014 (if i'm not mistaken)...



Thanks,
Trout

 

[ZASto]

There are some extempts from RoHS.

Restriction Exemptions

There are over 80 exemptions, some of which are quite broad. Exemptions will automatically expire after 5 or 7 years unless renewed.[16][18]

According to Hewlett Packard: "The European Union is gradually narrowing the scope of and expiring many of the current RoHS exemptions. In addition, it is likely that new substance restrictions will be introduced in the next several years."[16]

Some exemptions:[19]

Copper alloy containing up to 4% lead by weight is permitted. (Category 6c)
Lead in high melting temperature type solders (i.e. lead based solder alloys containing 85% by weight or more lead). (Category 7a)
The servers, switches, routers, cell sites and other telecommunication equipment that constitute the global Internet and phone systems are exempt from lead content restrictions. (Category 7b)
Cadmium in Solar panels - Cadmium telluride (CdTe) thin-film PV modules in photovoltaic panels are explicitly allowed by RoHS to contain unlimited cadmium, even though cadmium is restricted in all other electronics. The solar panel exemption was in the original 2003 RoHS regulation and it was further extended on May 27, 2011.[20]
Limited amounts of mercury in fluorescent and other light bulbs where it is essential to their functioning comprise RoHS 2 Categories 1, 2, 3, 4, and 5.

Medical devices were exempt in the original directive, which meant they could contain unlimited amounts of toxic metals and plastics and still be marketed as RoHS compliant.[21] RoHS 2 narrowed the exemption's scope to active implantable medical devices only (Category 4h). In Vitro Diagnostic Devices (IVDD) and other medical devices are now included.[22]

Automotive vehicles are exempt (category 4f). Vehicles instead are addressed in the ELV (End of Life Vehicle) 2000/53/EC Directive.[23]

Quote is from: https://en.wikipedia.org/wiki/Restriction_of_Hazardous_Substances_Directive

 

[marce]

It is not so much the flux that you need to worry about it is having the assemblies done to IPC class 3 standard, same with the PCB.
here is a quick link;

**broken link removed**

 

[IanTrout]

Thanks for the link @marce!
But I don't think this really applies for us, its only for R&D use...


Thanks for all the help,
Trout