Tissues - Documents

This section consists of documents that pertain to tissue products.

  • Click here to view information on ISBT 128 and the Single European Code (SEC).

 

IN-007 ISBT 128 for Tissues, An Introduction  PDF

This document provides an overview of the ISBT 128 Standard and how it applies to tissue products. It also describes the elements needed to achieve standardization and how the standard is used to encode information into machine-readable form.

 

ST-003 ISBT 128 Standard Labeling of Human Tissues v1.0.0 – PDF

This document is intended to help facilities and software developers design appropriate ISBT 128 labels for tissue products. Greater detail is given for labeling than that provided in the ISBT 128 Technical Specification.

 

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

This document provides specific rules and guidance in the implementation of the SEC for ISBT 128 labeled products. This standard must be read in conjunction with the relevant EC and national legislation and regulatory requirements. It is the responsibility of the tissue establishment (TE) applying the SEC to ensure that labels comply with applicable regulation.

Note: A tool for creating the SEC for an ISBT 128 product can be found in the Lookup Tools section of the website. Click here to access the Single European Code (SEC) Builder Tool. 

 

IG-014 Implementation Guide: Use of Data Matrix Symbols with ISBT 128 v1.3.0 – PDF

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The purpose of this document is to assist users and software developers to implement Data Matrix two-dimensional (2-D) symbology for delivery of ISBT 128 data structures for labeling of medical products of human origin as well as for patient wristbands. Labeling includes affixed, attached, and accompanying labeling.

 

IG-020 Implementation Guide: Encoding Product Information [Data Structures 003, 032, 033, and 034] - Tissues v2.0.0 - PDF

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The purpose of this document is to provide detailed information about ISBT 128 product coding for tissues. Specifically, it:

  • Describes the data structures used in product coding
  • Compares two methods of encoding product information
  • Describes the database that supports the internationally standardized Product Description Codes (PDC)
  • Explains how to select an appropriate PDC
  • Explains how to request new PDCs
  • Explains the use of the Facility-Defined Product Code (FPC)
  • Provides guidance on the coding of divisions (or packs)

 

IG-031 Implementation Guide: Use of the Processing Facility Information Code [Data Structure 033] v1.1.0 - PDF

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The purpose of this document is to provide guidance in the implementation and use of the Processing Facility Information Code [Data Structure 033]. This data structure is designed for use by Cellular Therapy and Tissues facilities to convey information about the facility that assigned the Product Code and may include a facility Product Code assigned by the processing or labeling facility.

 

TB-007 ISBT 128 and the Single European Code v1.4.0 – PDF

This document provides information regarding the use of ISBT 128 and the Single European Code (SEC).

 

TB-009 Revised Cardiovascular Tissue Terminology v1.0.0 – PDF

The purpose of this document is to provide a cross-reference to cardiovascular terminology used prior to February 2014 (in versions 4.32.0 of the database and before) and that used after March 2014 (versions 4.33.0 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 cardiovascular terminology is added.

 

TB-011 Revised Bone Tissue Terminology v1.0.0 – PDF

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.

 

GS1 and ICCBBA Guidance: Identification of medical devices containing an HCT/P in the United States  PDF

This guidance document applies to the identification of human cells, tissues and cellular and tissue-based products (HCT/Ps) that are regulated as medical devices using a Unique Device Identifier (UDI) as required under the US Food and Drug Administration’s (FDA’s) Unique Device Identification System Final Rule (78 FR 58785; September 24, 2013).

The rationale that applies to the use of ISBT 128 for tissues regulated as medical devices applies equally to its use for traditional tissues. Therefore, ICCBBA also encourages the use of ISBT 128 for tissues regulated as biologics to provide a consistent means of coding all tissue for transplantation.   

GS1 and ICCBBA, working within the terms of an existing Memorandum of Understanding, have developed this document to clarify the appropriate use of the GS1 and ISBT 128 unique device identifiers, and the interfaces between the standards.

 

Example Implementation Plan – PDF

This example plan was meant to be comprehensive, and not all steps may be needed by all facilities. Therefore, facilities should use it as a guide or checklist of things to consider rather than attempting to follow it precisely.