What is ICCBBA?
ICCBBA (International Council for Commonality in Blood Banking Automation) is an international non-profit organisation that develops and maintains the ISBT 128 standard: the global system for the terminology, identification, coding and labelling of medical products of human origin (MPHO), such as blood, cells, tissues, human milk and organs. ICCBBA assigns every blood or tissue establishment a unique number, manages the product code database and defines how barcodes, labels and electronic messages are structured. As a result, a hospital can scan a unit of red cells or a stem cell graft from another country without any translation and trace it back to the donor.
🧠 How did ICCBBA and ISBT 128 come about?
In the late 1980s, blood banks mostly used Codabar barcodes, with a separate numbering structure per country or even per facility. In 1989 the International Society of Blood Transfusion (ISBT) proposed a uniform successor. The key milestones:
| Year | Event |
|---|---|
| 1989 | The ISBT proposes a worldwide coding standard based on Code 128 |
| Early 1990s | AABB, America’s Blood Centers and the American Red Cross set up CCBBA to introduce the standard in the US |
| 1994 | On 3 July, at the ISBT congress in Amsterdam, the ISBT Council approves the specification; CCBBA becomes ICCBBA |
| 1995 | ICCBBA becomes an independent non-profit and publishes version 1.0 of ISBT 128 |
| 2017 | ISBT 128 is one of three permitted coding systems for the Single European Code (SEC) for tissues and cells |
| 2019 | The EU designates ICCBBA as an issuing entity for the UDI of medical devices |
The name ISBT 128 refers to the 128 characters of the 7-bit ASCII character set the standard uses. ICCBBA is based in Redlands, California, holds ISO 9001 certification and works through volunteer technical advisory groups per product area, such as cellular therapy, tissues, ocular tissue, human milk and organs.
🧱 Which products does ISBT 128 apply to?
ISBT 128 covers every MPHO category with one consistent structure:
- Blood and blood components - red cells, plasma, platelets and cryoprecipitate
- Cellular therapy - stem cell grafts, bone marrow and cord blood, including the production of ATMPs under GMP
- Tissues - bone, skin, heart valves and ocular tissue (cornea)
- Human milk - donor milk from milk banks
- Reproductive material - oocytes, sperm and embryos
- Organs - identification of donor organs and associated samples
Professional bodies such as AABB, FACT, JACIE and the Eye Bank Association of America support ISBT 128 in their accreditation standards. Several countries, including Austria, Portugal, Poland and Brazil, require its use by law. National blood services such as NHS Blood and Transplant in the United Kingdom work with ISBT 128, as do hospitals, tissue banks and donor and transplant registries. Australia switched in 2018, using a transition label that temporarily carried both ISBT 128 and legacy Codabar barcodes.
🔢 How is an ISBT 128 code structured?
ISBT 128 works with data structures: each data item starts with a data identifier of one or two characters, followed by the content. This way a scanner or LIMS always knows which field it is reading, regardless of order or carrier. The most important structures on a blood component label:
| Data structure | Format | Meaning |
|---|---|---|
| 001 Donation Identification Number (DIN) | = + 13 characters + 2 flag characters |
5-character facility identification number (FIN), 2-digit year, 6-digit sequence number |
| 002 Blood groups | =% + 4 characters |
ABO/RhD blood group plus Rh and Kell phenotype |
| 003 Product code | =< + 8 characters |
5-character core code (E or F for blood components), donation type and divisions |
| 005 Expiration date and time | &> + 10 characters |
Century, year, ordinal (Julian) day, hour and minute |
| 017/018 Container | =) / &) |
Manufacturer, catalogue number and lot number of the blood bag |
An example DIN is A999908123456: facility A9999, year 2008, donation 123456. Because the year
and the globally unique facility number are part of the code, a DIN remains unique for a hundred years.
The two flag characters are not part of the number itself; blood establishments use them for process
control, and they may differ from label to label. Next to the number sits a boxed check character,
calculated with ISO 7064 modulo 37-2, which catches typing errors during manual entry.
The product code (Product Description Code) comes from the ISBT 128 Product Code Database that ICCBBA maintains. The core code describes the component class, anticoagulant, storage conditions and attributes such as irradiated or washed. A range of codes is reserved for internal use with in-process components. Requesting a new product code usually takes four to six weeks if no new terminology is needed.
🏷️ What does an ISBT 128 label look like?
The standard blood component label measures 100 by 100 mm and is divided into four quadrants of 50 by 50 mm. The barcodes sit in the same relative position worldwide: DIN and blood group side by side at the top, product code and expiry date at the bottom. This placement enables concatenation: a scanner reads two barcodes in a single sweep as one data item, so a DIN is never combined with the blood group of a different bag. The bag manufacturer’s base label (100 by 106 mm) carries the container and lot barcodes.
The linear barcodes are Code 128, the same symbology GS1 uses, but with their own data identifiers. For 2D, ICCBBA chose DataMatrix, which fits all data into a single code. ISBT 128 data can also be carried by RFID transponders and exchanged in electronic messages in XML, JSON and HL7 FHIR. Each barcode is accompanied by the same information as human-readable text, so staff can still check what they are holding if a scanner fails. Additional attributes such as CMV-negative or irradiated are recorded in the product code or in separate special testing data structures. Label text may be in the local language; the encoding inside the barcode is identical everywhere. That unambiguity is exactly what prevents mix-ups in transfusion and transplantation.
🔗 How does ISBT 128 compare with GS1 and HIBC?
| System | Managed by | Application | Characteristic |
|---|---|---|---|
| ISBT 128 | ICCBBA | Blood, cells, tissues, milk, organs (MPHO) | DIN per donation, product code from a central MPHO database |
| GS1 | GS1 | Trade items, medicines, medical devices | GTIN per item, application identifiers |
| HIBC | HIBCC | Medical devices and hospital supplies | Recognisable by the + character, labeler code per manufacturer |
| Eurocode | Eurocode IBLS | Blood and tissues, mainly in Germany | One of the three permitted SEC systems |
Each system has its own role in the EU: ISBT 128 and Eurocode in the SEC for tissues and cells, and GS1, HIBC, ISBT 128 and IFA as UDI systems for devices. For medical devices, Implementing Decision (EU) 2019/939 designated GS1, HIBCC, ICCBBA and IFA as UDI issuing entities; that designation has been extended until 27 June 2029. The FDA likewise accredits ICCBBA as a UDI issuing agency.
🔧 How do you implement ISBT 128 in practice?
For a tissue bank, cell therapy lab or hospital, ISBT 128 is an IT/OT project that touches label printers, scanners, cold storage and quality systems. A common approach:
- Register - the facility applies to ICCBBA for a licence and a Facility Identification Number; an annual licence fee applies.
- Map products - local product names are mapped to ISBT 128 product codes; missing codes are requested from ICCBBA.
- Adapt systems - the blood or tissue establishment software, the LIMS and the interface with the ERP system must support the data structures, the check character and the concatenation rules.
- Validate labels and scanners - printers, templates and handheld scanners are tested for readability and correct field mapping, documented according to GAMP, with attention to data integrity and to 21 CFR Part 11 when exporting to the US.
- Maintain the database - the product code database is updated regularly and each update must be released into production in a controlled way.
In the EU, tissue establishments have had to apply the Single European Code (SEC) from Directive (EU) 2015/565 to tissues and cells since 29 April 2017. The SEC is preceded by “SEC” and consists of a donation identification sequence (2-character country code, 6-character establishment code, 13-character donation number) and a product identification sequence with a system letter: “A” for ISBT 128, “B” for Eurocode or “E” for the EU’s own EUTC. A globally unique ISBT 128 DIN may serve as the donation number. The new SoHO Regulation (EU) 2024/1938 replaces the blood and tissue directives from 7 August 2027 and puts donor-to-recipient traceability even more at the centre.
❓ Frequently asked questions
What does ICCBBA stand for?
ICCBBA stands for International Council for Commonality in Blood Banking Automation. The organisation grew out of the US-based CCBBA in 1994 and has been an independent non-profit since 1995. Its ISBT 128 standard now covers not only blood but also cells, tissues, milk and organs.
Is ISBT 128 mandatory in the EU?
ISBT 128 is not prescribed as the only system across the EU. For tissues and cells, the Single European Code applies, in which ISBT 128 is one of three permitted product coding systems alongside Eurocode and EUTC. Accreditation standards such as FACT-JACIE for stem cell transplantation do explicitly support ISBT 128.
What is the difference between ISBT 128 and GS1?
ISBT 128 identifies individual donations and products of human origin, using a DIN that is unique per donation. GS1 identifies trade items with a GTIN per product type plus a serial number or batch number. Both use Code 128 and DataMatrix, but with different data identifiers, so a scanner can tell them apart.
What is a Donation Identification Number?
The Donation Identification Number (DIN) is the 13-character number with which ISBT 128 uniquely identifies every donation worldwide. It consists of a 5-character facility identification number, the last two digits of the year and a 6-digit sequence number. All products made from one donation carry the same DIN.
Does using ISBT 128 cost money?
Yes, facilities that use ISBT 128 register with ICCBBA and pay an annual licence fee. This funds the non-profit’s maintenance of the standard, the product code database and the help desk. ICCBBA publishes the current terms and fees in the licensing section of its website.
Which barcodes does ISBT 128 use?
ISBT 128 uses linear Code 128 barcodes with its own data identifiers and DataMatrix as its 2D barcode. The data can also be transferred via RFID transponders and electronic messages such as HL7 FHIR. The position of the barcodes on the label is fixed worldwide.
📌 In summary
ICCBBA maintains ISBT 128, the global standard that makes blood, cells, tissues, milk and organs traceable from donor to recipient through a unique donation number, a standardised product code and a fixed label layout.
ISBT 128 combines centrally managed code tables with Code 128 and DataMatrix barcodes, a strict label design and electronic messaging. In Europe it is one of the permitted systems for the SEC and a UDI system for medical devices. For those building the systems, it is above all a matter of compliance, validated labelling and reliable data exchange across the healthcare chain.