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Version 5.8.0 of the ISBT 128 Standard Technical Specification (ST-001) is now available

Version 5.8.0 of the ISBT 128 Standard Technical Specification (ST-001) is now available.

[21 June 2017]


Version 3.1.0 of the ISBT 128 Standard Global Registration Identifier for Donors ION Database and GRID Rules (ST-015) is now available

Version 3.1.0 of the ISBT 128 Standard Global Registration Identifier for Donors ION Database and GRID Rules (ST-015) is now available.

This document provides information on the structure of the GRID Issuing Organization Database as well as instructions on how to obtain an ION, how to update the ION information within the database, and how to use a GRID for hematopoietic progenitor cell (HPC) donors and potential donors.

[21 June 2017]


Version 3.4 of the GRID Issuing Organization Number Database is Now Available

The data files associated with the GRID Issuing Organization Number (ION) Database can be found here:

The specifications for the structure of the Global Registration Identifier for Donors (GRID) Issuing Organization Number (ION) and information on how to obtain and update an ION can now be found in the GRID Issuing Organization Number Database standards document (ST-015).

[20 June 2017]


The Registered Facilities Database Has Been Updated

The Registered Facilities Database has been updated and is now available to licensed facilities. The database contains the names and locations of all ICCBBA-registered facilities worldwide and their assigned Facility Identification Numbers (FINs). It is available both as an Excel file (Registered Facilities.xlsx) and as a tab-delimited text file (Registered Facilities.txt).

Both files are available in the password-protected area of the website. Amendments to entries in these tables should be notified to the ICCBBA office.

For US facilities registered and/or licensed with the FDA, the name and location of your facility—as it appears in the Registered Facilities Database—should match what appears on your FDA registration and/or license.

[06 June 2017]

 


Version 1.7.0 of "ISBT 128 Standard Coding and Labeling of Medical Devices Using ISBT 128” (ST-011) is Now Available

Click here to access the "ISBT 128 Standard Coding and Labeling of Medical Devices Using ISBT 128” document (ST-011).

[05 June 2017]


The Device Identifier Checker Tool is Now Available

The Device Identifier Checker is now available in the Lookup Tools section of the website. This tool allows you to parse the various elements of the ISBT 128 Device Identifier (DI).

[05 June 2017]


Version 7.4.0 of the ISBT 128 Product Description Code Database is Now Available

Version 7.4.0 of the ISBT 128 Product Description Code Database can be downloaded from the Product Description Code Database page.

Please note that as of the release of version 7.0.0 of the database (Jan 06, 2017), various tables and fields that related to the old structure of the database were removed. For more information, see ST-010 ISBT 128 Standard Product Description Code Database.

[12 May 2017]


The UDI Generator is Now Available

The Unique Device Identifier (UDI) Generator is now available in the Lookup Tools section of the website. This tool allows you to create the UDI for an ISBT 128 product.

[18 April 2017]


The SEC Builder Tool is Now Available

The Single European Code (SEC) Builder Tool is now available in the Lookup Tools section of the website. This tool allows you to create the SEC for an ISBT 128 product.

[06 April 2017]


Version 5.4.0 of the Special Testing General Database is Now Available

Version 5.4.0 of the Special Testing General database is now available. Codes were added to indicate Zika negative test results in conjunction with a negative test result for the following:

  • “Hemoglobin S negative”
  • “CMV seronegative” + “Hemoglobin S negative”

The database and its associated Version Control Sheet can be found here.

[04 January 2017]


TEPTAG has been changed to RMTAG (Regenerative Medicine Technical Advisory Group)

The name of the Tissue Engineered Products Technical Advisory Group (TEPTAG) has been changed to Regenerative Medicine Technical Advisory Group (RMTAG). "Tissue Engineered" is a term used in European regulations; therefore, this change has been made to prevent the incorrect association between TEPTAG and the rules applied by the EU Commission to human tissue engineered products.  In addition, the two types of products under the governance of this TAG are: regenerated tissues and seeded scaffolds. This also fits the name change.

[15 December 2016]


Version 1.1.0 of the “ISBT 128 Standard Labeling of Blood Components” (ST-005) and Version 1.2.1 of the “Implementation Guide: Use of the Manufacturers Data File” (IG-015) documents are now available

ST-005 ISBT 128 Standard Labeling of Blood Components v1.1.0

This document is intended to help facilities, label vendors, and software developers design appropriate ISBT 128 labels for blood products.

 

IG-015 Implementation Guide: Use of the Manufacturers Data File v1.2.1

The purpose of this document is to provide implementation guidance on the use of the Manufacturers Data File. Specifications pertaining to the Manufacturers Data File are contained in the ISBT 128 Standard Technical Specification (ST-001) and this information must be read for a complete understanding of the subject.

[15 December 2016]


Updates to “Implementation Guide” documents pertaining to Ocular Products

Version 1.2.0 of the “Implementation Guide: Use of Product Code [Data Structure 003] - Ocular Tissue” (IG-032) is now available.

 

Version 1.4.0 of the “Implementation Guide: Use of ISBT 128 in North American Eye Banks” (IG-040) is now available.

[30 November 2016]