The quality and reliability of electronic equipment is vital for every industry, but it is especially critical in the medical industry where human life and safety depend on equipment operating as intended. This formidable responsibility not only impacts the device manufacturer, but the suppliers of every enabling component.
Current medical market trends driving collaboration between medical device and connector manufacturers include increased demand for safety and regulatory compliance, lower-cost disposable solutions, higher-resolution imaging capabilities, and enhanced durability.
Device manufacturers rely heavily on their connector manufacturer partners to deliver solutions that will effectively drive their most innovative product designs while also meeting size, cost, performance and compliance demands. Connector suppliers often draw upon their experience in other areas of the diverse medical device industry, as well as in other connector-critical market sectors — including the aviation, aerospace and automotive industries — to overcome challenges and enable the next-generation of medical devices.
Improved safety and regulatory compliance
The integration of additional features and functional capabilities means these devices are more susceptible to the effects of electrostatic discharge (ESD). Although static shocks are a widespread phenomenon, they can be hazardous in medical environments — causing software to freeze, reboot or malfunction, damaging delicate circuity, or even shocking patients and operators. As a result, the International Electrotechnical Commission (IEC) nearly doubled its ESD performance requirements in the fourth edition of the IEC 60601-1-2:2014 standard, which was published in 2014 and required global device compliance by Dec. 31, 2018. The minimum voltage that a panel-mounted receptacle must withstand is now 15 kV, measured from the receptacle housing to the internal electrical contacts, which represents a dramatic increase from the 8 kV minimum mandated by the previous edition of the standard.
To address new project developments with challenging connectivity demands, plastic REDEL SP series connectors are recommended. They offer advanced features including eight additional high-density electrical contacts in the same small form factor and a tested ESD resistance of 25 kV, which not only meets the new IEC standard, but also provides medical device designers plenty of room for future-proofing designs. For current applications that require backward compatibility, the popular REDEL 1P series plastic achieved an ESD rating of 13 kV, which is well over the incumbent standard, but still slightly short of the new one. LEMO USA’s engineering team quickly identified an elegant solution: by simply adding a thicker dress nut to their connectors, customers can meet the demands of the new standard without a costly redesign.
Read more: Key technology trends driving the medical connector market