I need some advice about requirements for labelling of programmed devices and wondered if someone can point me at documentation (FDA/ISO/IEC/BS) that identifies the exact labelling information required.
I want to implement a PCB/programmed component labelling system across company that treats all programmable devices equally (EEPROMS, uC, PLDs, FPGs...etc) whether they are programmed on or off PCB.
I've read certain parts of the FDA 820 and BS EN 60601 (my company is medically based) but the only info defining labelling requirements I found was MIL-STD 130/129. This document appears to provide some light.
Our corporate systems allow full batch traceability but my argument for device labelling is simply based on gut feel that 'you can't beat a label'! Of course my presumption assumes that human readable info on programmed devices assists the field service personnel (and anyone else come to think of it) identify it's content but to assist me I need to point at a document saying "thou shall label all programmed devices with the following information:". This makes my life much easier in the convincing certain departments of this route.
What are the minimum identification markings for a device label - part number, firmware version, date of programming?
What happens to the device when a user upgrades the firmware - the label's firmware number is now invalid.
How does industry label devices too small to affix labels?
How does industry cope with batch programming and labelling at a latter date?
Does industry really need a label on programmed devices at all - what's the real purpose?
Thanks for any input chaps. Lea