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Combined Interpretations of the 2003, 2009, and 2016 Standards that apply to Volume 1 of the 2016 TNI Standard


Question:  Are microorganisms considered standards?  Does the lab need to assign an expiration date on them? The reference cultures the lab receives from ATCC does not have expiration dates. The lab is following the protocol for microorganism listed in Appendix D3.7.

TNI Response:  The ATCC reference cultures are "reference materials" and must adhere to the requirements of (2003). These requirements include the requirement of having an expiration date whether supplied by the vendor or assigned by the laboratory.  This requirement was removed in 2009 and remains as such. The SIR is obsolete.