Standards for Blood Banks and Transfusion Services, 35th Edition
AABB's consensus standards for blood collection, processing, testing, distribution and transfusion, built — in AABB's words — on best medical practice, scientific data, principles associated with good manufacturing practices and quality assurance, and applicable regulations. The 35th edition was released on 2 March 2026 and took effect on 1 April 2026, replacing the 34th.
Always verify against the current published text before relying on it for a submission or inspection.
Scope & applicability
Blood banks, blood centers and hospital transfusion services that hold or seek AABB accreditation. Accreditation against these standards carries CMS deemed status for the laboratory activities AABB covers, so an AABB assessment can stand in for a federal inspection; FDA's blood regulations (21 CFR 606, 610, 630, 640) still apply independently.
Key requirements
- Requirements are the statements that use "shall"; failing one is a nonconformance under the AABB Accreditation Program
- The standards are organised on AABB's quality system essentials (updated in 2023), the framework BB/TS Standards has used since the 20th edition in 2000
- Records: a standard marked with the pen symbol requires a record of the activity, with content and retention set by the record-retention tables
- Clarified notification of AABB about accreditation-relevant changes, equipment investigations after nonconformances, and monitoring of critical technology infrastructure (35th edition)
Implementation tips
- Map each AABB standard to the FDA regulation it overlaps before an assessment — the standards do not preempt federal, state or local law, so meeting the AABB clause does not discharge the 21 CFR obligation
- A variance is effective only for the edition in which it was granted; renew it before a new edition's effective date
Revision notes
The 35th edition took effect on 1 April 2026, released on 2 March 2026. It clarifies notification of AABB about accreditation-relevant changes, refines expectations for equipment investigations following nonconformances, establishes monitoring requirements for critical technology infrastructure, and adds a standard requiring preparation of pathogen-reduced cryoprecipitated fibrinogen complex per the manufacturer's instructions.
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
AABB BB/TS Standards, 35th ed.: frequently asked questions
Quick answers to common questions about AABB BB/TS Standards, 35th ed..
What is AABB BB/TS Standards, 35th ed.?
AABB BB/TS Standards, 35th ed. — Standards for Blood Banks and Transfusion Services, 35th Edition — is a standard issued by the Association for the Advancement of Blood & Biotherapies (United States / International). AABB's consensus standards for blood collection, processing, testing, distribution and transfusion, built — in AABB's words — on best medical practice, scientific data, principles associated with good manufacturing practices and quality assurance, and applicable regulations. The 35th edition was released on 2 March 2026 and took effect on 1 April 2026, replacing the 34th.
Who does AABB BB/TS Standards, 35th ed. apply to?
Blood banks, blood centers and hospital transfusion services that hold or seek AABB accreditation. Accreditation against these standards carries CMS deemed status for the laboratory activities AABB covers, so an AABB assessment can stand in for a federal inspection; FDA's blood regulations (21 CFR 606, 610, 630, 640) still apply independently.
What are the key requirements of AABB BB/TS Standards, 35th ed.?
AABB BB/TS Standards, 35th ed. requires, among other things: Requirements are the statements that use "shall"; failing one is a nonconformance under the AABB Accreditation Program; The standards are organised on AABB's quality system essentials (updated in 2023), the framework BB/TS Standards has used since the 20th edition in 2000; Records: a standard marked with the pen symbol requires a record of the activity, with content and retention set by the record-retention tables; Clarified notification of AABB about accreditation-relevant changes, equipment investigations after nonconformances, and monitoring of critical technology infrastructure (35th edition).
When was AABB BB/TS Standards, 35th ed. last updated?
The current version of AABB BB/TS Standards, 35th ed. dates from April 2026. The 35th edition took effect on 1 April 2026, released on 2 March 2026. It clarifies notification of AABB about accreditation-relevant changes, refines expectations for equipment investigations following nonconformances, establishes monitoring requirements for critical technology infrastructure, and adds a standard requiring preparation of pathogen-reduced cryoprecipitated fibrinogen complex per the manufacturer's instructions.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.