Back in 2006 ERA Technology carried out a review covering Medical Devices and Monitoring and Control Instruments for the European Commission.
The RoHS Directive covered 8 of the 10 categories of the WEEE Directive.
The two that were not included were those above namely categories 8 and 9.
At the time there were concerns around the reliability of lead-free solder.
Today the RoHS recast finally provides implementation dates along with a dedicated Annex (4) of exemptions.
Medical Equipment will enter into force 3 years after publication in the Official Journal (OJ) other than in-vitro diagnostics that will be 5 years.
Consumer Monitoring and Control will be 3 years and Industrial 6 years.
|Category 8 products in scope|
Blood pressure meters (consumer types and professional types)
Blood analysers, e.g. cholesterol, sugar (consumer types and professional types)
Self-test kits - electrical types (consumer and professional types)
Oxygen analysers (respiration monitors)
Immunoassay analysers (IVD)
Intravenous drug infusion pumps
Hospital beds that rely on electricity for their main function
Electrical surgical tools (saws, etc.)
Operating theatre equipment
Proton therapy facility including particle accelerator
Electric scooters used by disabled (as a transport product)
Hospital beds that are not dependent on electricity
|Category 9 products in scope|
Battery powered smoke detector (used in households)
Battery powered thermostat (used in households)
Carbon monoxide detector (used in households)
Weighing equipment except for households
Chemical analysis equipment such as spectrometers
pH and conductivity meters
Chromatograph for chemical analysis
Equipment for calibration of other products
Portable digital thermometer
Voltmeters, ammeters, etc. not used as components within other products
X-ray imager for luggage (except those used for national security)
X-ray imager for examination of internal parts of products
Network cable tester
Semiconductor parameter tester
Optical power meter
Roadside traffic warning beacons. Category 9 as the main function is “control (of traffic)” (not used for illumination therefore not Category 5)
|Monitoring and control - type products whose scope requires clarification|
Smoke detector as part of alarm system installed in buildings
Household scales (included in Category 1)
Burglar alarm systems installed in buildings
Equipment used to prepare samples for analysis such as grinding equipment, mixers, extraction systems, etc. (tools?)
Laboratory centrifuge (tool?)
Other laboratory equipment such as ultrasonic cleaners, fume hoods, distillation equipment, heating equipment, etc. (some could be regarded as Category 6)
Preparative chromatograph (Category 6?)
Petrol pumps (part of fixed installation, Category 9 or 10?)
Some types of CCTV monitoring equipment (or Category 3?)
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