Bulletin 18-4​

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Changes to AATB Standards​

Bulletin 18-4​

April 9, 2018​

On Wednesday, April 4, 2018, the AATB Board of Governors acted on a recommendation from the AATB Standards Committee and approved changes to the 14th Edition (2016) of AATB's Standards for Tissue Banking (Standards). This announcement requires your attention to review and potentially update your Standard Operating Procedures Manual (SOPM) and to educate staff.

The links below provide printable updates for each standard changed, as well as the implementation period and effective date of each update. For purposes of clarity, text that has been added appears as blue font (i.e. Example), and deleted text appears in red and is denoted with a strikethrough (i.e. Example).

Standards Changes:

A2.000 Definition of Terms, Electronic Quality Management Systems

Appendix II Items 3 and 5 Human-derived Clotting Factor

D4.240 Archived Samples

E2.500; E2.510 Processing and Storage

J5.300 Qualification and Maintenance; J5.310 Requalification and Recalibration

K1.200 Qualification, Verification, and Validation Requirements

K2.520 Annual Calibrations

M6.310 Domestic Shipments