AATB Standards: what they are, who needs them, and how accreditation works

What are the AATB Standards?

The AATB Standards for Tissue Banking are the professional standards of the American Association of Tissue Banks for every step from donor screening to the distribution of human tissue for transplant. AATB inspects tissue banks against them and accredits those that meet them, for three years at a time. The current edition is the 15th, in effect since January 2025.

The Standards cover governance and the Medical Director, the quality program, donor screening and eligibility, authorisation and informed consent, recovery, processing, quarantine and storage, labelling, distribution, records and the reporting of adverse outcomes. They build on the FDA's 21 CFR Part 1271, which a registered tissue establishment must comply with whether or not it is accredited.

Who needs the AATB Standards?

The Standards become urgent when a hospital's purchasing team asks for the accreditation before it will list an allograft, when the AATB inspection goes on the calendar, or when a new edition is published and the procedures still cite the last one.

Standards that apply alongside AATB accreditation

Pharma manufacturingcGMP (21 CFR 210 and 211): The drug manufacturing regulations that apply as well once a tissue or cell product is more than minimally manipulated and is regulated as a biologic
Electronic records21 CFR Part 11: The FDA's rule for the electronic records and signatures the donor, processing and distribution records of Part 1271 are kept in
LaboratoriesISO 15189: The medical laboratory standard for the laboratory that runs donor infectious disease testing, in house or at a partner

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Questions about the AATB Standards

What are the AATB Standards for Tissue Banking?

The professional standards of the American Association of Tissue Banks for recovering, processing, storing and distributing human tissue for transplant, from donor screening to a record of where each graft went. AATB inspects tissue banks against them and accredits those that meet them. The current edition is the 15th, released in July 2024 and in effect since January 2025.

Is AATB accreditation mandatory?

Not under federal law. The FDA requires registration and compliance with 21 CFR Part 1271 and inspects for it. AATB accreditation is voluntary.

What is the difference between AATB accreditation and FDA registration under Part 1271?

Part 1271 is the FDA's rule and applies to every establishment that handles human cells or tissue. The FDA inspects for compliance and does not accredit.

How does AATB accreditation work?

A tissue bank applies, submits its procedures and records for review, and hosts an on-site inspection by AATB inspectors against every section of the Standards. Findings are answered with corrective action before accreditation is granted.

Can we add the AATB Standards to the standards we already run in Qualio?

Yes. Add them from the library and Qualio assesses the records you already hold against every section, beside 21 CFR Part 1271 or cGMP if you run those too. Sections the frameworks share count once, and the first assessment lists what is covered and what is new.

When is the AATB inspection?

Bring the date and your current procedures. We will show you the Standards assessed against them section by section, with the gaps listed and the evidence exported the way the inspector reads it.

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