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A terminology proposal for “Reproductive Tissues” is now available for public comment

The "Internationally Standardized Terminology for Reproductive Tissues" consultation document is now available for public comment. Comments should be submitted by January 31, 2017.

  • Click here to access the proposed terminology and electronic voting form.

[Updated: 11 January 2017]
[Original Date: 18 November 2016]


Version 7.0.1 of the ISBT 128 Product Description Code Database is Now Available

Version 7.0.1 of the ISBT 128 Product Description Code Database is now available. In addition to the structural changes made to the database for the version 7.0.0 release (Jan 06, 2017),* the product description in the PRODDESCRIP0 field for E0001 was corrected back to WHOLE BLOOD|ACD-A/450mL/refg.

*Version 7.0.0: The various tables and fields that related to the old structure of the database were removed for this version release. ST-010 ISBT 128 Standard Product Description Code Database was updated to reflect the new structure of the database.

[10 January 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.

[10 January 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]


A terminology proposal for “Regenerated Tissue and Seeded Scaffolds” is now available for public comment

The "Internationally Standardized Terminology for Regenerated Tissue and Seeded Scaffolds” consultation document is now available for public comment. Comments should be submitted by January 31, 2017.

  • Click here to access the proposed terminology and electronic voting form.

[06 December 2016]


Version 1.6.0 of "ISBT 128 Standard Coding and Labeling of Medical Devices Using ISBT 128” (ST-011) and Version 1.3.1 “ISBT 128 and the Single European Code (SEC)” (ST-012) documents are now available

ST-011 ISBT 128 Standard Coding and Labeling of Medical Devices Using ISBT 128 v1.6.0

This document provides specific requirements and guidance for facilities labeling medical devices that contain human cells, tissues, and cellular and tissue-based products (HCT/P) that are regulated as medical devices.

 

ST-012 ISBT 128 and the Single European Code (SEC) v1.3.1

This document provides specific rules and guidance in the implementation of the SEC for ISBT 128 labeled products.

 

[05 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]


The Manufacturer Identifier Codes table [RT016] has been updated

The Manufacturer Identifier Codes table [RT016] has been updated and can be found in the Reference Tables section of the ICCBBA website.

This table lists the Vendor codes for manufacturers who encode their identities in Data Structure 017 or 021.

[10 November 2016]


Version 5.6.0 of the ISBT 128 Standard Technical Specification (ST-001) and Version 1.2.0 of the Use of the Manufacturers Data File (IG-015) are Now Available

Version 5.6.0 of the “ISBT 128 Standard Technical Specification” manual (ST-001) is now available.

 

Version 1.2.0 of the “Manufacturers Data File” document (IG-015) can be found here.

[02 November 2016]


IG-041 Implementation Guide: Use of ISBT 128 in Resource-Limited Countries v1.0.0 is Now Available

The purpose of this document is to provide guidance for implementation of the ISBT 128 Standard for blood transfusion in resource-limited countries. It is intended to provide options allowing facilities to promote safety, traceability, and efficiency without needing to implement all features of the ISBT 128 Standard.

[24 August 2016]


Updates to ICCBBA Documents – July 2016

The following ICCBBA publications have been updated and are available on the ICCBBA website:

All ISBT 128 Implementation Guidelines (IG-###) can be found here.

[21 July 2016]


IG-042 Implementation Guide: Revised Bone Tissue Terminology v1.0.0 is Now Available

The purpose of this document is to provide guidance and cross reference between bone terminology used prior to August 2015 (in version 6.7.0 of the database and before) and that used after September 2015 (version 6.8.0 of the database and after).This document is intended to provide users with information that will help them transition from the old terminology to the new. This document will not be updated as new bone terminology is added.

[23 June 2016]


The Circular of Information for the Use of Cellular Therapy Products has been updated.

The Circular of Information for the Use of Cellular Therapy Products has been updated.

[03 June 2016]


2016 ICCBBA One World Award Recipient

ICCBBA is pleased to announce Rodeina Davis as the recipient of the 2016 ICCBBA One World Award! To view the associated press release, please click here.

[10 March 2016]


ST-013 ISBT 128 Standard Labeling of Human Milk Banking Products v1.0.0 is Now Available

This document provides ISBT 128 requirements for information that shall appear on the final label for human milk banking products. It is intended to help facilities and software developers design appropriate ISBT 128 labels for human milk banking products.

[16 February 2016]


IG-038 Implementation Guide: Use of the Global Registration Identifier for Donors [Data Structure 037] v1.0.0 is Now Available

This Implementation Guide specifies the format and use of the Global Registration Identifier for Donors (GRID), which is represented in ISBT 128 by Data Structure 037. The guidance has been developed jointly by the WMDA and ICCBBA under the terms of a Memorandum of Understanding.

Click here to access the document.

29 September 2015