User Categories

ICCBBA grants three types of licenses for the use of ISBT 128; Vendor, Limited Use Vendor, and Facility. Each license category has unique limitations as to how licensees can use ISBT 128. To view the grant of license for each category, refer to section 4.0 of the License Agreement.

​The three categories for licenses are listed below:

Vendors

  • Label Vendor: A vendor who provides pre-printed labels carrying ISBT 128 data structures.

  • Medical Product Vendor: A vendor of products that use an ISBT 128 data structure that contains a Manufacturer’s Identifier Code allocated by ICCBBA.

  • Software Vendor: A vendor providing software to customers that generates and/or outputs ISBT 128 data structures. This category includes: blood establishment computer system vendors, vendors of information management systems for MPHO facilities, and on-demand label printing system vendors.

  • Vendor Combined Software and Other: A vendor who meets the criteria of a software vendor and also provides non-software products/services that use ISBT 128 to 10 or more customers.

Limited Use Vendor

  • Application Service Provider: A vendor who provides a service via a software application that utilizes ISBT 128 databases (FIN database, Product Database) but does not generate or output ISBT 128 data structures.

  • Consultant: A vendor who provides consultancy services related to the implementation and/or use of ISBT 128. This category of user is limited to access of ISBT 128 databases, documents, and help desk services only.

  • Supporting Vendor: A vendor that supports the use of ISBT 128 data structures in their products and wishes to promote their compliance with ISBT 128 as a licensed vendor. This category of user is limited to access of ISBT 128 databases, documents, and help desk services only.

Facility

  • Facility: An organization that assigns ISBT 128 Donation Identification Numbers, labels products with ISBT 128 data structures, and/or uses ISBT 128 and its accompanying databases, documentation, and software tools. This category includes: Blood banks, transfusion services, chain of identity identifiers, tissue establishments, cord blood banks, eye banks, cellular therapy labs, plasma fractionation facilities, proficiency testing organizations, medically assisted reproduction facilities, regenerative medicine facilities, medical devices containing HCT/P facilities, human milk banks, organ transplant facilities.

The ISBT 128 information standard and its accompanying databases, reference tables, documentation and software tools are licensed and not sold. ISBT 128 is owned by ICCBBA and protected by copyright.

Facility vs. Vendor: Which User Type Are You?

Facility

  • Primary Role
     Blood center, tissue bank, organ procurement organization, cord blood bank, or other healthcare facility using ISBT 128.

  • Use of ISBT 128
    Applies ISBT 128 Standard directly to label and track medical products of human origin (MPHO). Utilizes ISBT 128 data structures, databases, and reference tables.

  • Licensing Need
    Requires a Facility License to generate and apply ISBT 128 identifiers and labels, and to access password protected content on the ICCBBA website.

  • Examples
    Blood banks, transfusion services, chain of identity identifiers, tissue establishments, cord blood banks, eye banks, cellular therapy labs, plasma fractionation facilities, proficiency testing organizations, medically assisted reproduction facilities, regenerative medicine facilities, medical devices containing HCT/P facilities, human milk banks, organ transplant facilities.

  • End Use
    Directly labels, manages, and traces patient- or donor-related products.

Vendor

  • Primary Role
    Company providing products, software, or services that support facilities using ISBT 128.

  • Use of ISBT 128
    Develops or supplies systems, equipment, labels, or services that incorporate or support ISBT 128.

  • Licensing Need
    Requires a Vendor License to integrate ISBT 128 into their products or services.

  • Examples
    Software developers, label manufacturers, medical device companies, IT system providers.

  • End Use
    Provides solutions that enable facilities to implement ISBT 128 effectively.

Definitions of Use

LICENSE HOLDER AGREEMENT

The ISBT 128 information standard and its accompanying databases, reference tables, documentation, and software tools are licensed and not sold. ISBT 128 is owned by ICCBBA and protected by copyright. Click on the button below to view ICCBBA’s License Agreement (FM-086).

If you do not accept and comply with the terms in the License Agreement (FM-086), you may not use ISBT 128 and its accompanying databases, reference tables, documentation, or software tools.

Inquiries regarding the License Agreement (FM-086) can be sent to license@iccbba.org.