AATB accreditation is a private accreditation of tissue banks, measured against the AATB Standards for Tissue Banking, 15th edition, as revised by AATB Bulletins. This service is for tissue banks and establishments that recover, process, store or distribute tissue and are preparing for an AATB inspection. Integral Healthcare Solutions (IHS) builds the document system and quality records for AATB accreditation; your tissue specialists own donor eligibility and processing.
Last reviewed: October 2026. AATB's Standards, Accreditation and Bulletin 26-1 pages and its Accreditation Policies checked on October 2, 2026.
What is AATB accreditation?
The governing text is the AATB Standards for Tissue Banking. AATB says: "First published in 1984, the AATB Standards for Tissue Banking (Standards) are the only private tissue banking standards published in the United States," and "A new 15th edition of Standards was released in 2024 and became effective in January 2025" (AATB Standards). AATB's site footer now uses the name Association for Advancing Tissue and Biologics.
The Standards change between editions. "AATB Standards are subject to revision at any time pursuant to the Association's procedures. Notice of each such revision is given by AATB via a 'Bulletin'" (AATB Standards). Bulletin 26-1, dated July 27, 2026, states: "The third revision to Standards for Tissue Banking, 15th edition (Standards), having been approved by the Board of Directors, is being released. This revision of Standards will become effective as of January 31, 2027" (AATB Bulletin 26-1).
The accreditation process is governed by the AATB Accreditation Policies, effective January 1, 2024, in the version revised December 15, 2025 (AATB Accreditation Policies). AATB summarizes it: "The accreditation process involves several steps: application, inspection, evaluation, and review." "Inspections are carried out by a team of qualified, independent assessors. Following the inspection, a detailed report is reviewed by the AATB Accreditation Committee," and "Accreditation is valid for three years" (AATB Accreditation).
Who needs it and what triggers it
- Tissue establishments in states that point to AATB. AATB says "Currently, several states' statutes and/or regulations reference AATB's Standards, institutional accreditation, or individual certification" (AATB Standards). This page does not list those states; check your own state's rules.
- New establishments that have been operating for six months. New applicants need "Full operational status and compliance with AATB Standards for at least six months prior to application" and "Maintenance of comprehensive records for each activity performed over the past six months" (AATB Accreditation).
- Accredited banks approaching renewal. The establishment "will receive the Accreditation Application from AATB via electronic notification nine (9) months prior to the expiration of its accreditation" and "shall submit the Accreditation Application within 45 days of receipt" (AATB Accreditation Policies).
- Banks updating procedures for a Standards revision, such as the third revision effective January 31, 2027 (AATB Bulletin 26-1).
How IHS helps
IHS works from your bank's copy of the AATB Standards for Tissue Banking and the current Bulletins. The process:
- Gap assessment. Questionnaires on the activities your bank performs, then a comparison of current procedures and records with each applicable standard.
- Document and evidence mapping. A crosswalk from each standard to the procedure or record that shows it is met, including the six months of records new applicants need.
- Drafting. IHS drafts the document architecture, training records and quality-review procedures for your tissue specialists and medical leadership to review and approve.
- Mock review. A review against the Standards before the inspection, listing what is missing.
- Readiness support. IHS drafts responses to inspection findings for your bank to review and submit.
What you supply: the Standards and Bulletins, your SOPs, donor and processing records, and tissue specialists who own donor eligibility and processing validation. Your bank completes the New Applicant Interest Form, applies and hosts the inspection. For related programs, see the accreditation consulting practice.
The limit: donor eligibility, processing validation and product safety are technical and medical decisions that stay with your bank. IHS covers document architecture and quality records, and works from the Standards your bank provides.
What to have ready
- Your copy of the AATB Standards for Tissue Banking, 15th edition, effective January 2025 (AATB Standards).
- Every Bulletin issued since, including Bulletin 26-1 and the third revision effective January 31, 2027 (AATB Bulletin 26-1).
- The AATB Accreditation Policies, effective January 1, 2024, revised December 15, 2025 (AATB Accreditation Policies).
- A list of the activities your establishment performs, such as recovery, processing, storage and distribution, so the applicable standards can be set.
- Evidence of "Full operational status and compliance with AATB Standards for at least six months prior to application" (AATB Accreditation).
- "comprehensive records for each activity performed over the past six months" (AATB Accreditation).
- Controlled SOPs for each activity, ready for review by "a team of qualified, independent assessors" (AATB Accreditation).
- The New Applicant Interest Form, which "will be reviewed by AATB Accreditation Staff" (AATB Accreditation Policies).
- Budget for the application fee, since "Payment of the non-refundable application fee must be received to gain access to the application materials" (AATB Accreditation Policies).
- For renewal, a calendar entry nine months before expiration and a plan to submit within 45 days of receiving the application (AATB Accreditation Policies).
To go through the list with IHS, book the introductory call below.
How it compares
The table sets out the options the sources describe. Which apply depends on your tissue types and your state.
| Option | What the sources say |
|---|---|
| AATB accreditation | Private accreditation against the AATB Standards for Tissue Banking; inspection by independent assessors; review by the AATB Accreditation Committee; valid three years (AATB). |
| FDA 21 CFR Part 1271 compliance only | Federal rules for human cells, tissues, and cellular and tissue-based products (HCT/Ps). Part 1271 states: "You must register and submit a list of every HCT/P that your establishment manufactures within 5 days after beginning operations," and sets current good tissue practice requirements (eCFR, 21 CFR Part 1271). |
| EBAA accreditation | For ocular tissue. EBAA says its accreditation "is open to all entities that perform one or more eye banking functions, regardless of their EBAA membership status" (EBAA Accreditation). |
| AABB Standards for Cellular Therapy Services | For facilities that "procure, process, store and/or distribute cellular therapy products," that is, cellular rather than conventional tissue products (AABB Biotherapies). |
| State licensure | Several states reference AATB Standards or accreditation (AATB). This page does not identify which. |
What it costs
AATB does not publish a fee schedule on the pages we reviewed. Its Accreditation Policies refer to "an Accreditation Fee Schedule" and a "non-refundable application fee" but state no amounts (AATB Accreditation Policies, read October 2, 2026). Verify current fees with AATB. IHS scopes each engagement after a free introductory call.
What this is not
- IHS is not AATB and does not grant, predict or influence an accreditation decision, which follows the AATB Accreditation Committee's review.
- IHS does not submit to or speak for your bank to AATB or FDA. IHS drafts; your bank applies, hosts the inspection and makes any FDA filings.
- IHS does not make donor eligibility, processing validation or product safety decisions, and this page is not legal or medical advice.
Frequently asked questions
What is AATB accreditation and which tissue establishments can apply?
AATB accreditation is a private accreditation of tissue banks against the AATB Standards for Tissue Banking. New applicants need full operational status and compliance with the Standards for at least six months, with records for each activity over that period.
What changed in the 15th edition revisions and Bulletin 26-1, effective January 31, 2027?
Bulletin 26-1 releases the third revision of the 15th edition, approved by AATB's Board of Directors and effective January 31, 2027. This page does not summarize the content of the revision; read the Bulletin itself before updating procedures.
How long must a tissue bank operate before applying for AATB accreditation?
AATB requires full operational status and compliance with AATB Standards for at least six months before application. It also requires comprehensive records for each activity performed over the past six months.
What happens during an AATB inspection and who decides accreditation?
A team of qualified, independent assessors inspects the establishment. A detailed report is then reviewed by the AATB Accreditation Committee.
How much does AATB accreditation cost?
AATB does not publish fee amounts on the pages we reviewed. Its Accreditation Policies refer to an Accreditation Fee Schedule and a non-refundable application fee that must be paid before you can access the application materials. Verify current fees with AATB.
How long does AATB accreditation last and how does renewal work?
AATB says accreditation is valid for three years. The establishment receives the renewal application electronically nine months before expiration and must submit it within 45 days of receipt.
Does my state require AATB accreditation to operate a tissue bank?
AATB says several states' statutes or regulations reference its Standards, institutional accreditation or individual certification. This page does not identify those states, so check your state's own rules.
How does AATB accreditation relate to FDA 21 CFR Part 1271 compliance?
Part 1271 is the federal rule for HCT/P establishments, covering registration and listing, donor eligibility and current good tissue practice. AATB accreditation is a separate, private program measured against AATB's own Standards.
What records will inspectors expect to see for the six months before application?
AATB requires maintenance of comprehensive records for each activity performed over the past six months. Which records apply depends on the activities your establishment performs.