Re: Programmed device - labelling requirements?

On 9 May 2005 11:10:52 -0700, "LeaUK" <lea@xxxxxxxxxxxxxx> wrote:

>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


We assign a software ID number and rev letter to each formal software
release. A typical number might be 22376B. We stick a label on every
programmed part, no matter how it's programmed.

We use mostly Xilinx FPGAs, which are ram based, so we don't label
them. A typical product will have an eprom or a flash chip that
contains uP code and one or more Xilinx config files, all rolled up
into a single release.

John

.

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