pipette acceptable standards

[umeshkumar]

Hi,

Are we supposed to follow thwe ISO 8655 stds for inaccuracy and precision of pipettes. When we look at guidelines from different labs upto 5% inaccuracy and 5% CV is acceptable for pipettes < 50 ul and 3% inaccuracy and imprecision is acceptable for pipettes > 50 ul.

What are the references that site these levels? can someone provide me a good reference for piptette cali standards?

thanx

[David Saikin]

the FDA looks at what precision your testing requires. I set my limits to the test wihcih has the strictest requirements (+/- 2% in my lab). You need to look at your test's pkg insert to see what precision is required . . . that is the standard.

[umeshkumar]

hi david,

thanks. are these limits applicable to all volumes?

the FDA looks at what precision your testing requires. I set my limits to the test wihcih has the strictest requirements (+/- 2% in my lab). You need to look at your test's pkg insert to see what precision is required . . . that is the standard.

[David Saikin]

You need to see what your pipet applications are. If you use the same ones all the time I would make my goal to comply with the most stringent. It depends on what the pkg insert calls for as far as pipet precision goes. For me, the applications called for 5% and 2% so I set my limit as 2% precision.

[umeshkumar]

thanks david

You need to see what your pipet applications are. If you use the same ones all the time I would make my goal to comply with the most stringent. It depends on what the pkg insert calls for as far as pipet precision goes. For me, the applications called for 5% and 2% so I set my limit as 2% precision.

[stacybyars]

There are several places to find information and graphs about ISO standards but its unfortunate the the ISO makes you purchase certain types of documentations.

Here are 3 reference pages for ISO Standards that might be of assistance.

*ISO 8655 (explanation & maximum number of permissible errors)

*ISO 17025 (explanation, history & FDA relationship)

*Calibration & Repair Process (interesting break-down here)

These pages show great detail in what to expect from ISO standards other than what iso.org can show you. Not only do they explain what the "standard" is, they also explain how they attain this "standard". I hope this information help you on your way. Good luck.