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Recently I received an email inquiry from a LinkedIn group member that asked about the appropriate inspection requirements and operator certification for soldering electronic components to a printed circuit board for medical devices.
The ISO 13485 Standard, 2003 and 2016 versions, do not specifically identify these requirements. The reason is that these are generic quality system standards that are not specific to a type of medical device. The only similar type of requirement which is addressed is sterility.
Some manufacturers will sample components from reels of components and verify the values (i.e., resistance or capacitance). I have also seen companies verify the solderability of components during incoming inspection, verify that there is no lead content for lead-free components and to verify markings are consistent with product specifications.
Verification of purchased product has always been part of ISO 13485 in clause 7.4.3 and in the QSR under 21 CFR 820.80. Typically this is done as a visual inspection using a component specification. However, there is also in-process inspection required. it is common for printed circuit board (PCB) manufacturers to have automated optical inspection (AOI) equipment with libraries to look for specific features printed on components in order to detect potential counterfeit parts at the end of the production line as production / process control.
In addition, the personnel responsible for final inspection of PCBs are typically trained to inspect solder joints, components on PCBs and the overall board. IPC J-STD-001F is the only active standard in any industry for soldering while IPC A-610F is for electronic assemblies. You can obtain training from various sources. Here’s an example: http://www.soldertraining.com/, but there are training facilities all over the country. There are three types of training:
1. for the person soldering
You only need training types 1 and 2 if you send people out to courses. There are training visual aids that show good and bad solder joints and there is a practical exam.
Other types of production / process controls for PCBs include: 1) validation of the solder masking process, 2) in-circuit testing to verify continuity of circuits, 3) functional testing and 4) x-ray inspection. Some manufacturers even use specialized fiber-optic vision systems to monitor the soldering of integrated circuits with ball-grid arrays (BGAs) real-time.
When you are qualifying suppliers and re-evaluating existing suppliers you need to make sure that your requirements for production / process controls are defined in writing. Some PCBs you order may have different inspection requirements that need to be specified in your purchase order. These requirements should be articulated in your supplier quality agreements as well–which are now a requirements of ISO 13485:2016 in Clause 4.1.5.
The FDA and other regulatory bodies to do not require all of these controls, but you are required to demonstrate competency and validation of processes where 100% inspection is not performed. As registrars being to audit to the new ISO 13485:2016 Standard, we can expect increased emphasis on training competency and risk-based controls.
If you are interested in learning more about the changes in ISO 13485:2016, please register for tomorrow’s webinars on this topic: http://medicaldeviceacademy.com/iso-13485-2016-webinars/.
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Gordon Skiba In addition to the standards Robert listed, I'd recommend the following:
Electronic (active) medical devices will have to comply with IEC 60601-1, 60601-1-2, 60601-2-57 and other medical device requirements to name a few of the major standards; these will then specify compliance with the EMC standards (IEC 61000 series), compliance to these particular standards will be dictated by the energy-source, intended-use (implant, invasive, theraputic, life-supporting, etc...). You'll have to comply with title 21 part 820, and 93/42/EEC for sales in Europe. As for component acceptance standards, you should consider IPC A-600 for the bare printed circuit board, IPC 7711/7721 for rework/repair of your PCBA's, and IPC A-620 for wire-harness assemblies. I'd also recommend you review the requirements for RoHS, Dodd-Frank section 1502 (if your company is publicly-traded). Individual standards exist for component acceptance sampling, including ANSI Z1.4, or ANSI Z1.9. Good luck!
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