The American Association of Tissue Banks (AATB) is pleased to announce that the 14th edition of the AATB
Standards for Tissue Banking (Standards) is now available for purchase. This edition is being published online first and will be followed in a few months with availability of the print copy. For the first time ever, you are able to purchase institution-wide Internet access or single-user Internet access and both can be bundled with printed copies. To place an order, click
here.
Note that initially, Internet access will be to a searchable PDF version of the 14th edition. However, when AATB launches its new website in the next few months, a fully functional, interactive Standards-only link will become available to those who have purchased Internet access. The print version will be available to purchase by the beginning of October.
Due to the depth and breadth of the changes to the Standards and additional materials included, AATB is taking the unique step of allowing nearly twice the usual period of time to come into compliance with new requirements. An effective date of "within 90 days" was used with previous editions but, for the 14th edition, more than 5 months is being used for the expectation to become compliant with new requirements. The effective date for compliance to the 14th edition is January 1, 2017.
To assist with recognizing updates, two documents have been created and are available at these links:
Additionally, AATB Interim Guidance Document No. 5, Standard K2.210 Pre-sterilization/Pre-disinfection Cultures, 1-4-11, has been updated to version 2 and renamed:
This guidance update is the culmination of years of work from members who are subject matter experts and we wish to acknowledge officials at FDA/CBER who provided considerations for improvement for which we are very grateful. Note that the advisory nature of this guidance will eventually become mandatory.
To clarify expectations for compliance, three documents previously referred to as "AATB Guidance Documents" each became incorporated as an appendix to the Standards. For example, Appendix III Tissue Donor Physical Assessment Form Requirements was formerly "AATB Guidance Document No. 1, v2 Tissue Donor Physical Assessment Form, 6-27-05." Version 2 was updated by members of the Recovery and Donor Suitability Council, a draft of their revisions was offered to relevant AATB Councils for comment, comments were considered and responses developed, and the final, approved version now appears as Appendix III after review by the Standards Committee and approval by the Board of Governors. To view comments received and the responses developed, refer to:
For questions related to ordering the Standards, contact Jamien Payne. For questions regarding specific standards, appendices, or guidance documents, contact Scott Brubaker.
