Version 4

    rohs directive legislation.jpg

     

    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)

    Endoscope

    Ultrasound

    CT scanner

    PET

    X-ray imaging

    Medical thermometer

    Dialysis equipment

    Medical Freezers

    Gamma Camera

    Intravenous drug infusion pumps

    Ventilators

    Defibrillators

    Pacemakers

    Hearing aids

    Surgical microscope

    Hospital beds that rely on electricity for their main function

    Electrical surgical tools (saws, etc.)

    Medical lasers

    ECG

    Anaesthesia equipment

    Operating theatre equipment

    Dental equipment

    Proton therapy facility including particle accelerator

    Veterinary products

    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

    Light meter

    pH and conductivity meters

    Chromatograph for chemical analysis

    Equipment for calibration of other products

    Portable digital thermometer

    Surveying instruments

    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

    Spectrum Analysers

    Oscilloscopes

    Network cable tester

    Semiconductor parameter tester

    Signal generator

    Waveform monitor

    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 ovens

    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?)

     

     

     

     

    • Register with element14 to be able to receive the latest RoHS Directive legislation updates

     

    • Found the information, now get the part! Visit our online store

     

    • Got an opinion you want to share? Leave your comments below