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
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
email@example.com e-mail address.
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