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RoHS – July Deadline Nearing for In Vitro Product Compliance

Posted by Anna Bolan

By Anna Bolan – Medical Market Manager

As part of the second installation of RoHS, medical device manufacturers of in vitro diagnostics equipment have until July 22, 2016 to be RoHS 2 compliant. Exemptions for manufacturers of products that are included as RoHS Category 8 and 9 are set to expire on this date. In vitro products and certain types of monitoring and control instruments must meet the EU’s standards regarding the six restricted chemicals that are regulated as part of RoHS compliance.

Examples of Category 8 Medical products that must comply include:

Anesthesia Equipment Electric Surgical Tools Medical Thermometers
Blood Analyzers (IVC) Endoscope Operating Theater Equipment
Blood Pressure Meters External Defibrillators & Pacemakers Oxygen Analyzers
CT Scanner Gamma Camera PET
Diaylsis Equipment Hearing Aids Surgical Microscopes
ECG Immunoassay Analyzers (IVD) Ultrasound
Electrical Self Test Kits (IVD) Intravenous Drug Infusion Pumps Ventilators
Electrical Function Dental Equipment Medical Freezers X-ray Imaging
Electrical Function Hospital Beds Medical Lasers

Active implantable medical devices continue to remain outside of the RoHS compliance scope.

Examples of Category 9 Monitoring & Control instruments that must comply include:

Alarm System Smoke Detectors Light Meters Semiconductor Parameter Testers
Building Burglar Alarm Systems Luggage X-ray Imagers Signal Generators
Building/Room Thermostats Measuring, Monitoring or Control Veterinary Products Smoke Detectors
Calibration Equipment Network Cable Testers Spectrum Analyzers
Carbon Monoxide Detectors Non-component Voltmeters & Ammeters Surveying Instruments
CCTV Monitoring Equipment Optical Power Meters Test Instruments
Chemcial Analysis Equipment Oscilloscopes Traffic Lights
Chemical Analysis Chromatoraph pH & Conductivity Meters (except for home and education use) Waveform Monitors
Control Temperature Laboratory Ovens Portable Digital Thermometers Weighting Equipment (except household scales)
Internal Product Parts Examination X-ray Imagers Roadside Traffic Warning Beacons

A majority of our customers do supply products to Categories 8 and 9. Some products, such as custom equipment cases, custom sewn bags and fluid collection bags, Polo manufactures for our customers will need to meet RoHS 2 standards. We’ve anticipated the RoHS 2 directives and our global supply chain is ready to meet all standards required by our customers.