ICCBBA

What ICCBBA does

ICCBBA (International Council for Commonality in Blood Banking Automation) is a 501(c)(3) nonprofit international standards organization founded in 1994 and headquartered in Redlands, California (with mailing address in San Bernardino). The organization develops and manages the ISBT 128 Standard — the global standard for the terminology, identification, coding, and labeling of medical products of human origin (MPHO), encompassing blood, cells, tissues, organs, human milk, and regenerative medicine products. ISBT 128 specifies globally unique Donation Identification Numbers (DIN), Product Description Codes (PDCs), Facility Identification Numbers (FINs), and a Chain of Identity (CoI) Identifier (ST-028), encoded into Code 128 and 2D Data Matrix barcodes and interoperable with healthcare information systems through XML and HL7 FHIR (including contributions to the FHIR R5 BiologicallyDerivedProduct resource).

ICCBBA operates with a lean staff of 1-10 employees (Executive Director, Technical Manager, Education Specialist, Development Officers, Global Development Manager, Creative Services Coordinator) supported by an all-volunteer Board of Directors of up to 11 members and a network of Technical Advisory Groups (TAGs) and Standards Committees. Revenue is generated entirely through licensing fees: facilities pay based on the total number of DINs assigned annually or the total number of final ISBT 128 labeled products distributed annually, with discounts available under the World Bank Country Income Classification, while vendors pay licensing fees for embedding the standard in software, barcode printers, and healthcare IT systems. Distribution is via direct licensing agreements, a self-serve online registration and payment portal, and complementary tools such as the SEC Builder Tool (for EU Single European Code compliance) and the IG-043 Validation Tool.

The standard is deployed in over 5,000 facilities across 89 countries on six continents and is required or endorsed by major professional and accreditation bodies including AABB, FACT/JACIE, WMDA, EBAA, ASTCT, ISCT, and EBMT. ICCBBA is recognized as a Unique Device Identifier (UDI) issuer by the U.S. FDA, European Union, Saudi FDA, and Australia's TGA, holds official relations status with the World Health Organization, and is ISO 9001:2015 certified (Certificate No. 1118463). Recent strategic activity has emphasized geographic expansion (Africa and India under Strategy 2025-2027), cellular therapy and regenerative medicine use cases, and an updated brand and website launched in December 2025.

Name

ICCBBA

Legal name

ICCBBA

Website

https://iccbba.org

Company type

Private

Founded year

1994

Operating status

Operating

Headcount range

11–50 employees

Short description

ICCBBA is a 501(c)(3) nonprofit standards organization that develops and manages the ISBT 128 Standard for terminology, identification, coding, and labeling of medical products of human origin, serving 5,000+ facilities across 89 countries through a licensing-based revenue model.

Ownership category

akta.pro rank

Product category

Healthcare Identification Standards

NAICS

Blood and Organ Banks (621991), Medical Laboratories (621511)

SIC

Services-Medical Laboratories (8071), In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro industry

PRIMARYHLAHAAAH

Blood Bank, Transfusion Medicine & Immunohematology

Healthcare & Life Sciences/Medical Devices & Diagnostics/In Vitro Diagnostics (IVD) & Laboratory Diagnostics

SECONDARYHLAFAMAG

Transfusion Medicine & Immunohematology (Blood Bank)

Healthcare & Life Sciences/Healthcare Providers & Systems/Clinical Laboratories

SECONDARYBPADAAAJ

International Standards, Norms & Technical Regulatory Bodies

Business & Public Services/International Organizations & Development/Multilateral & Intergovernmental Organizations

SECONDARYHLACABAA

Interoperability Standards, Profiles & Implementation (HL7/FHIR/IHE)

Healthcare & Life Sciences/Digital Health & Health IT/Health Information Exchange (HIE) & Interoperability

SECONDARYHLAJAIAM

Laboratory Quality Systems, Accreditation & Proficiency Testing Programs

Healthcare & Life Sciences/Public Health, Government & Regulators/Public Health Laboratories & Reference Testing Networks

Keywords

• ISBT 128 standard
• Medical product labeling
• Healthcare identification standards
• Blood transfusion coding
• Cellular therapy traceability

Headquarters

HQ city

San Bernardino

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure, Others

Revenue model

1. Licensing Fees - Facilities: ICCBBA's operations are funded entirely from licensing fees collected from facilities using the ISBT 128 Standard. Fees are billed based on the total number of Donation Identification Numbers (DINs) assigned annually or on the total number of final ISBT 128 labeled products distributed annually. Discounts are available for countries based on World Bank Country Income Classification.
2. Licensing Fees - Vendors: Licensing fees collected from vendors providing equipment or software that incorporates the ISBT 128 Standard.

Pricing tiers

Go-to-market motion1 record

Distribution channels4 records

Marketing channels9 records

Core offering

ICCBBA develops and manages the ISBT 128 Standard, the global standard for terminology, identification, coding, and labeling of medical products of human origin (MPHO) including blood, cells, tissues, organs, milk, and regenerative medicine products. The organization licenses the standard to healthcare facilities and vendors, and provides supporting technical specifications, reference databases, validation tools, and implementation guidance to enable accurate traceability from donor to patient across healthcare systems worldwide.

Product overview

ICCBBA offers the ISBT 128 Standard as its core product, which is a global standard for terminology, identification, coding, and labeling of medical products of human origin. The portfolio includes technical specifications (ST-001, ST-002), standards documents (ST-012, ST-017, ST-018, ST-028), reference databases (Product Description Code Database, Registered Facilities Database), and tools (SEC Builder Tool, IG-043 Validation Tool, Quick K Calculator, Product Lookup Web Application, Cellular Therapy Audit Tool). These products support healthcare organizations in implementing standardized labeling and traceability for blood, cells, tissues, organs, and other MPHO across six continents.

Differentiator

Problem solved

Functional benefit

Products and services

• ISBT 128 Standard Global standard for terminology, identification, coding, and labeling of medical products of human origin (MPHO), licensed to healthcare facilities and vendors. Used on six continents and endorsed by professional communities including AABB, FACT/JACIE, WMDA, EBAA, ASTCT, ISCT, and EBMT.
• SEC Builder Tool Downloadable tool designed to help European Union tissue and cellular therapy establishments create a Single European Code (SEC) for ISBT 128 labeled products by integrating ISBT 128 data structures with SEC requirements.
• IG-043 Validation Tool for ISBT 128 Data Structures Implementation guide providing expanded guidance and examples to assist facilities, vendors, and software developers in validating ISBT 128 data structures within their systems. Version 1.4.0 covers 15 data structures.
• Quick K Calculator Online calculator that computes the Check Character required for some ISBT 128 Data Structures.
• ISBT 128 Product Lookup Web Application Web application for submitting Product Description Code requests and searching for ISBT 128 Product Descriptions, replacing previous request forms.
• Cellular Therapy Audit Tool Audit tool for assessing compliance to ISBT 128 requirements for cellular therapy products, also usable for self-assessment or gap analysis during implementation.
• ISBT 128 Product Description Code Database Comprehensive database of standardized product description codes used for identifying and labeling medical products of human origin. Version 7.53.0 and later releases include codes for various product categories.
• Registered Facilities Database Database containing names and locations of all ICCBBA-registered facilities worldwide and their assigned Facility Identification Numbers (FINs), available as Excel and tab-delimited text files for licensed facilities.
• On-Demand Learning and Webinars Educational videos, webinars, and slideshow presentations covering ISBT 128 implementation, product coding, clinical trials, traceability, and various MPHO applications including the Encode It Accurately series, Ask ICCBBA sessions, Enterprise Grant workshops, and vendor training.

Quantifiable outcome

• Over 5,000 facilities across 89 countries use ISBT 128 for standardized MPHO labeling and traceability
• +2 more outcomes

Named customers9 records

Segments9 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature9 records

Partnerships

Twelve partnerships are on record, tiered core and minor.

• World Marrow Donor Association (WMDA)coreStrategic or Co-development Partner · 13 May 2026Lydia Foeken, CEO of WMDA, joined the ICCBBA Board of Directors in May 2026. WMDA leads global initiatives to strengthen donor care, data protection, certification, and international collaboration in hematopoietic stem cell transplantation. The partnership advances harmonized standards and accreditation in cross-border cell exchange.
• AABBcoreStrategic or Co-development PartnerAABB (Association for the Advancement of Blood & Biotherapies) requires ISBT 128 compliance for labeling blood and cellular therapy products. ICCBBA partnered with AABB to host the ICCBBA Learning Lab at the 2025 AABB Annual Conference.
• FACT/JACIEcoreStrategic or Co-development PartnerFACT/JACIE makes compliance with ISBT 128 Standard a requirement for labeling cellular therapy products. ICCBBA collaborates with FACT on standards development and implementation.
• Standards Coordinating Body (SCB)coreStrategic or Co-development PartnerCollaborated with SCB to develop requirements for ST-028 Chain of Identity Identifier for linking donations in cellular therapy manufacturing.
• World Health Organization (WHO)coreStrategic or Co-development PartnerICCBBA is a non-state actor in official relations with WHO. ICCBBA develops standards in alignment with WHO resolutions including WHA63.22 on coding systems for human cells, tissues, and organs.
• HL7 InternationalcoreTechnology or IntegrationICCBBA is an active participant in HL7 FHIR Orders and Observations Healthcare Product group, contributing to the enhanced BiologicallyDerivedProduct resource in HL7 FHIR R5 for standardized electronic transfer of blood product information.
• Therapeutic Goods Administration (TGA) - AustraliacoreStrategic or Co-development PartnerTGA officially recognized ICCBBA as a Unique Device Identifier (UDI) issuer in 2025, listing ICCBBA alongside GS1 and HIBCC in Therapeutic Goods Legislation Amendment Regulations 2025. This aligns with similar acceptance by FDA, EU, and Saudi FDA.
• Cellular Therapy Industry Partners (ST-018)coreStrategic or Co-development PartnerST-018 developed in collaboration with bluebird bio, GlaxoSmithKline, Gilead Sciences, Johnson & Johnson, Juno Therapeutics, Kite Pharma, Legend Biotech, NMDP/Be The Match, Deloitte, AABB, FACT, Standards Coordinating Body for Regenerative Medicine, TrakCel, and Vineti.
• International Society for Cell & Gene Therapy (ISCT)coreStrategic or Co-development PartnerCTCLAG collaborated with ISCT's mesenchymal stromal cell committee to produce a consensus statement on standard nomenclature abbreviations for tissue of origin of mesenchymal stromal cells, published in Cytotherapy journal.
• Professional Community EndorsementscoreStrategic or Co-development PartnerISBT 128 is widely endorsed by professional communities including ISBT, WMDA, EBAA, ASTCT, ACBTSA, AABB, ASFA, ISCT, and EBMT.
• African Society for Blood Transfusion (AfSBT)coreStrategic or Co-development PartnerAfrica is identified as a special focus region in ICCBBA Strategy 2025-2027. ICCBBA was represented at AfSBT Biannual Conference in Windhoek, Namibia in March 2026, presenting on traceability for Africa's blood supply.
• Enterprise Grant Partner OrganizationsminorStrategic or Co-development PartnerAnnual Enterprise Grant program funding organizations to strengthen ISBT 128 implementation. Recipients have included Dr. Sardjito Hospital (Indonesia), Safe Blood for Africa Foundation, and organizations in Cameroon, Ethiopia, Uganda, and Senegal over 8+ years.

Scale indicators6 records

Recent moves7 records

Expansion highlights6 records

Broad incumbents

• AABB: AABB is the leading professional and accreditation body for blood banking and biotherapies, and requires ISBT 128 compliance for member facilities. It is a peer in setting blood banking practice standards and a key channel for ICCBBA's standard adoption.
• European Committee for Standardization (CEN): CEN develops European standards including those underpinning the Single European Code for tissues and cells. It is a peer in healthcare standards-setting that intersects with ICCBBA's work through the SEC Builder Tool.
• FACT / JACIE: FACT (Foundation for the Accreditation of Cellular Therapy) and JACIE require ISBT 128 for cellular therapy product labeling. They are peer accreditation bodies in cellular therapy whose standards intersect directly with ICCBBA's labeling requirements.
• International Society of Blood Transfusion (ISBT): ISBT is the original organization behind the ISBT 128 naming and remains the leading professional society for blood transfusion science. It is a broad peer in the transfusion medicine standards community.

Direct peers

• GS1: GS1 is the largest global standards organization for barcodes and supply chain identification, co-recognized with ICCBBA as a UDI issuer by FDA, EU, TGA, and Saudi FDA. It is the most direct competitor in the UDI/labeling standards space and the dominant healthcare identifier standard globally.
• HL7 International: HL7 develops healthcare interoperability standards, including FHIR. ICCBBA actively contributes to the FHIR BiologicallyDerivedProduct resource, making HL7 a core peer in healthcare data interoperability standards.
• HIBCC (Health Industry Business Communications Council): HIBCC is one of the three FDA- and TGA-accredited UDI issuing agencies alongside ICCBBA and GS1. It provides identification standards for healthcare products and is a direct competitor in the medical device and supply labeling space.
• World Marrow Donor Association (WMDA): WMDA leads global standards and accreditation for hematopoietic stem cell transplantation and is a board-connected peer organization. WMDA's CEO joined ICCBBA's Board in 2026, and the two organizations collaborate on cross-border cell exchange standards.

Emerging players

• SNOMED International: SNOMED International maintains the global clinical terminology standard used across healthcare. It is an emerging/overlapping peer in healthcare terminology and coding that intersects with ICCBBA's MPHO product description codes.
• Regenstrief Institute (LOINC): Regenstrief maintains LOINC, the dominant standard for clinical laboratory test identification. It is an adjacent peer in laboratory and diagnostic terminology standards that intersects with ISBT 128 in clinical data exchange.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/ISBT128
• YouTubeyoutube.com/@iccbba4860
• LinkedInlinkedin.com/company/iccbba

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

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Frequently asked questions about ICCBBA