The ISO process and glucose meter standards


As readers probably know, I objected to the ISO standard 15197 for glucose meters issued in 2003 because 5% of the results were unspecified. My objections were made – in vain – before the standard was issued with emails to the ISO chairholder. But as it turns out, I wasn’t the only one who questioned the logic of having 5% of the results as unspecified. I came across this email from 2002 as I was cleaning up my PC. The response from the chairholder to the other person objecting was interesting. He said the comment had been brought up “too late in the process – in fact, outside the process.  If the comment had come in with the US vote, we would have been obliged to address it.”

It seems to me if the comment is valid it needs to be addressed – period.


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