RoHS Conformity Risk Assessment - Medical Devices

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SteveK

What would a RoHS conformity risk assessment look like for medical devices?

Is one really required?

If so has anyone got a (generic) example to share?

Steve
 

Mark Meer

Trusted Information Resource
Not sure why a separate risk assessment would be required...
Not even sure I know what you mean... Are you referring to a risk assessment of NOT complying (probably not recommended), or a residual risk assessment of trace hazardous substances that may still be present even though RoHS directive has been met?

I think probably line items in whatever risk assessment you have dealing with materials is probably sufficient:
- Hazard: poisoning by hazardous substances in materials, environmental contamination
- Risk: (evaluated)
- Mitigation: RoHS compliance SOP, materials testing..etc.
- Verification: Materials data, test-reports etc.
 
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