Programmed device - labelling requirements?

Hi all

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.

Some background:

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.

Some questions:

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

.

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