Bulletin 25-2

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Changes to Standards

REVISIONS OF STANDARDS SUBJECT TO AN EXTENDED (GREATER THAN SIX MONTHS) PREPARATORY PERIOD 

Changes to Standards

The first revision to Standards for Tissue Banking, 15th edition (Standards) is being released. Because the revisions impact requirements subject to an extended preparatory period, there is no change to the effective date. 

Revisions of Standards Subject to an Extended (Greater Than Six Months) Preparatory Period 

  • H31.000, H34.400, H34.500, and H37.700 regarding packaging

In January 2025, AATB published revisions in Standards specifying a temperature range in place of the term ambient and addressing instances where standards referenced ambient temperature. These revisions have an effective date of January 31, 2027. A working group of the Standards Committee that was convened to develop educational resources determined that some of the revisions - specifically, requirements for validating and applying expiration dates to transport packages (“shippers”) - could now be read to apply requirements to “ambient” tissue that were intended to apply only to refrigerated or frozen tissue. Clarifying revisions have been approved by the Standards Committee and Board of Governors. These revisions do not include new requirements and are being expedited, as they provide important information for accredited establishments that are currently working through implementation plans for the original revisions. 

The revisions replace the text previously included in red boxes that distinguish it from currently effective text. The January 31, 2027 effective date has not changed. 

A clean copy of Standards containing said changes is available to AATB members through the AATB Portal. Frequently Asked Questions Related to Standards for Tissue Banking will be made available through the AATB Portal in the coming days. It will include four sets of FAQs that respond to questions on Standards commonly received by AATB. One of these sets is dedicated to the ambient temperature labeling revisions.

If you have questions, please contact standards@aatb.org.