RoHS July 2014 Deadline: Medical Devices and Control Instruments

In 2011, the European Union issued a new directive that updates and supersedes RoHS; it has come to be known as the RoHS Recast or RoHS 2. Under the updated directive, as of July 22, 2014, RoHS restrictions will apply to Category 8, medical devices, and Category 9, monitoring and control instruments. Before we look at what those categories include specifically, here’s an overview of deadlines yet to come under the RoHS Directive.

So, what’s in Category 9, Monitoring and Control Instruments? The types of equipment that are in category 9 of the RoHS directive have a main function of monitoring or control, says Dr. Paul Goodman in Electronics Weekly, quoted here because it stands out as one of the better summaries of what to expect from Category 9. Monitoring, Goodman says, would include measurement – ergo thermometers, analytical spectrometers and digital voltmeters are all in category 9 because they monitor temperature, concentration, voltage, etc.

Monitoring and control functions are features of thermostats that monitor and control temperature and industrial process controllers that monitor and control a variety of process parameters. Other category 9 products include smoke detectors, fire alarms, traffic signals (control of traffic), X-ray imaging of luggage or electrical equipment (but not medical X-ray which is category 8), spectrum analyzers, etc. It is incorrect however, to assume that all laboratory equipment is in category 9 as these products must monitor or control as their main function. – Dr. Paul Goodman, EW

So, what’s in Category 8, Medical Devices? 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. Not anymore. Medical devices are still a broad category, and note that RoHS is not targeting “in vitro diagnostic medical devices” yet in 2014.

So what is targeted? For example:  radiotherapy equipment, cardiology, dialysis, pulmonary ventilators, nuclear medicine, laboratory equipment; other appliances for detecting, preventing, monitoring, treating or alleviating illness, injury or disability; but specifically excludes all implanted and infected products.

How are companies handling RoHS compliance? Industry’s leading companies are managing their compliance at various stages. There are challenges.

Certainly one challenge with RoHS is the many different formats suppliers use to submit their information. We asked a group of manufacturing risk assessment professionals on LinkedIn, “What form of documentation do you typically get from suppliers?” Here are the myriad answers.

Note: a good software should eliminate that challenge, for instance, by loading all information into a uniform data repository, so the resulting standardized data parameters are searchable, rational and reportable.

 

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