The ISO 13485 Standard is synonymous with quality and reliability for medical electronics products. Wire bonding is the newest technology coming on to the PCB assembly floor, and its basic requirements are for high quality and reliability to further support ISO 13485.
This renewed call for quality and reliability in wire bonding is emerging due to the growing demands of new generations of medical electronics products, which in some cases are becoming wearable devices. Those demands are for smaller printed circuit boards (PCBs) – characterized by high quality and reliability — as the basis for those newer, highly advanced medical electronic devices. Ever shrinking PCB real estate is not at a premium with little space remaining on small rigid and combination rigid-flex circuits.
Wire bonding, commonly used for connections between semiconductor die and its package, has arrived on the PCB assembly floor to connect bare die to substrates or on the small PCB, itself. This technology is not especially applicable in medical devices. These small boards have a combination of surface mount components and wire bonded chips or simply one or the other, depending on the PCB application.
To learn more about medical electronics reliability and quality associated with wire bonding read our article.
In the meantime, here are some tips and hints to give you a better understanding.
- Wire bonding for PCBs require a cleanroom that meets ISO 14644-1 Class 4/10,000 and the equivalent Federal Standard 209E (FS209E) Class 10, as shown in Fig. 1.
- Wire bonding can be either wedge bonding or ball bonding.
- It’s good to know that a specific head only bonds certain kinds of bonding, such as wire, ribbon or ball bonding. Also, the wire bonder head must be changed when wire thickness is changed.
- Ball bonding requires a highly precise electronic flame off (EFO) process.
- At times, the board must be cleaned with plasma etch, which provides another level of cleanliness to the board’s surface.
- Inspection and verification are two critical aspects of accurate and precise wire bonding for medical device manufacturing.
Medical electronics OEMs are currently conducting R&D on newer, more advanced products that demand the highest possible reliability because they’re mission critical. There can be no failures or flaws once they’re put in the field for demanding applications. Now, with greater emphasis on smaller, yet highly reliable medical electronics wearables and IoT devices, OEMs must place greater attention on their EMS Providers to determine the levels of quality and reliability they offer to further support ISO 13485.