Bulletin Board
Request for Comment: ISO/TC 212 Draft Standards
The NACB is a sponsor and member of ISO/TC 212, an international standards organization that is responsible for establishing a number of international standards covering many aspects of the practice of laboratory medicine. Since there is a good chance that these standards will affect our ability to practice clinical chemistry in this country, it behooves us to pay attention to these standards.

There are currently two draft standards being circulated for review and comment. The first is:
ISO/TC 212 N34, "Quality management in the medical laboratory".
This draft standard covers conventional and non-conventional testing, and provides practical guidance for laboratory procedures and the management of a clinical laboratory.

The second document:

ISO/TC 212 N35, is entitled "Determination of performance criteria for in vitro blood glucose monitoring systems for management of human diabetes mellitus".

This document addresses performance criteria for the glucometers and other such devices, as well as criteria for their use.

I hope that NACB members will review these documents and send their comments. The documents will either be on this Home Page or through our representative to ISO/TC 212, Larry Kaplan. If you are interested in reviewing one or both documents, contact Larry at 212 562-4216, or e-mail address.

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