Guidance Documents

List of ISBT 128 Implementation Guidelines  PDF [Last Modified: 22 September 2016]

 


United States Consensus - Blood

IG-002 United States Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128 v3.0.0  PDF (3 MB) 

The purpose of this document is to provide guidance on labeling requirements in the US for blood and blood components.

 

United States Consensus - Cellular Therapy

IG-003 United States Consensus Guidance for the Uniform Labeling of Cellular Therapy Products Using ISBT 128 v1.3.1  PDF (1 MB)

The purpose of this document is to provide guidance for users, software developers, and label vendors in the US in those areas of cellular therapy product labeling that are not internationally defined. 

 

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IG-008 Technical Bulletin 5: Bar Code Scanner Implementation of ISBT 128 Concatenation v1.0.0 – PDF

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This document provides information regarding the different types of barcode scanners that may be used for concatenation. It also provides solutions for some of the possible errors that may be encountered with the use of concatenation. 

 

IG-010 Technical Bulletin 7: Use of Flags in the Donation Identification Number for Process Control of Critical Points During Processing and Distribution v1.0.1 – PDF

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This document details the various applications of flag characters in the Donation Identification Number.

 

IG-011 Technical Bulletin 8: Specification for ISBT 128 Data Structures to support the secure bedside matching of patient and transfusion/transplant product identification v1.0.0 – PDF

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This document details how hospitals can use ISBT 128 to encode patient identification and how that information may be securely linked to compatible products to improve patient safety. 

 

IG-012 Technical Bulletin 9: Blood Bag Identification Using ISBT 128 and GS1 v1.0.0 – PDF

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This document provides guidance to blood bag manufacturers, their customers, and software developers on the bar coding of blood bags and their shipping containers. It deals with the relationship between information held in the GS1 carton codes and the ISBT 128 blood container label codes, and recommends ways to simplify the mapping between this information.

 

IG-013 Technical Bulletin 10: Valid and Invalid Bar Codes for use in ISBT 128 Validations v1.0.0 – PDF

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This document provides guidance to help software developers and their customers understand ISBT 128 data structures. It provides useable bar codes for software validation, to help verify the correct operation of software when reading valid and invalid information.

 

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-015 Implementation Guide: Use of the Manufacturers Data File v1.1.0 – PDF

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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 and this information must be read for a complete understanding of the subject.

 

IG-016 Technical Note 1: Case Conversion v1.0.0 – PDF

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This document identifies a potential problem when using ISBT 128 bar codes with a scanner connected via a PC keyboard port (commonly known as a “wedge” scanner).

 

IG-017 Technical Note 2: Length of the Product Code Bar Code and Concatenation v1.0.0 – PDF

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This document explains how shortening the length of bar codes by using Subset C of Code 128, can create problems for concatenation. It explains the significance of the placement of such bar codes, for concatenation to be successful.

 

IG-019 Technical Note 4: Manufacturer's Catalog Number and Lot Number (NOT Containers) v1.0.0 - PDF

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This document details the use of ISBT 128 data structures for tracking items other than containers.

 

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-021 Implementation Guide: Use of Product Code [Data Structure 003] - Blood v1.1.0 - PDF

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The purpose of this document is to provide guidance for the use of the Product Code [Data Structure 003] and its supporting database in the coding of blood components.

 

IG-022 Implementation Guide: Product Coding [Data Structures 003 and 032] - Cellular Therapy v1.2.0 - PDF

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The purpose of this document is to provide guidance in the use of the Product Code [Data Structure 003] and its supporting database in the coding of cellular therapy products. This document also discusses Product Divisions [Data Structure 032] and its role in traceability when used in conjunction with Data Structure 003.

 

IG-023 Implementation Guide: Use of Product Divisions [Data Structure 032] v1.1.0 – PDF

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The purpose of this document is to provide guidance in the use of Product Divisions [Data Structure 032] so that software may be developed to support it. 

This document is a guidance document to be used in conjunction with the ISBT 128 Standard Technical Specification (ST-001). It provides information about the format and use of the Product Divisions [Data Structure 032] when used in conjunction with the Product Code [Data Structure 003].

 

IG-024 Implementation Guide: Use of Flexible Date and Time [Data Structure 031] v1.1.0 – PDF

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The purpose of this document is to provide guidance in the use of the Flexible Date and Time [Data Structure 031]. This document is a supplement to the ISBT 128 Standard Technical Specification (ST-001). It:

  • Provides specific guidance for cellular therapy, ocular tissue, regenerated tissues, and organ transplantation in the use of the Flexible Date and Time [Data Structure 031].
  • Provides guidance on printing bar codes and text for dates on labels.
  • Addresses some concerns for software developers.

 

IG-025 Implementation Guide: US Guidance on Printing Text Associated with Red Cell Antigens v1.0.0 - PDF

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The purpose of this document is to provide guidance for the printing of text and the coding of Red Blood Cell antigen test results on the affixed blood label.

 

IG-026 Implementation Guide: Use of Dimensions [Data Structure 029] v1.2.0 – PDF

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The purpose of this document is to provide implementation guidance for users and software developers who wish to implement Dimensions [Data Structure 029].

 

IG-027 Implementation Guide: Use of Red Cell Antigens with Test History [Data Structure 030] v1.2.0 – PDF

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The purpose of this document is to provide implementation guidance for users and software developers who wish to implement Red Cell Antigens with Test History [Data Structure 030]. This document provides background information and examples of the use of Red Cell Antigens with Test History [Data Structure 030]. It provides supplementary information only and is therefore intended to be used in conjunction with the ISBT 128 Standard Technical Specification (ST-001).

 

IG-028 Implementation Guide: Use of ISBT 128 by North American Tissue Banks v1.3.0 - PDF

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The purpose of this document is to provide guidance on the implementation of the ISBT 128 Standard for North American tissues banks. Specifically it provides guidance on:

  • Donation identification numbering
  • Data structures that may be useful to tissue banks
  • Label design options
  • Software design

 

IG-029 Implementation Guide: Choosing an On-Demand Label Printer v1.0.1 - PDF

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The purpose of this document is to provide guidance for users who wish to procure on-demand label printers.

 

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.

 

IG-032 Implementation Guide: Use of Product Code [Data Structure 003] - Ocular Tissue v1.1.0 - PDF

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

  • Explains the Product Code [Data Structure 003] in detail
  • Provides a reference to information about the structure of the Product Description Code (PDC) database
  • Explains how to select an appropriate PDC
  • Explains how to request new PDCs

 

IG-033 Implementation Guide: Use of the Donation Identification Number [Data Structure 001] v1.1.0 - PDF

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The purpose of this document is to provide guidance for the use of the Donation Identification Number [Data Structure 001].

 

IG-034 Implementation Guide: ISBT 128 Facility Identification Number v1.2.0 - PDF

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The purpose of this document is to provide guidance for the use of Facility Identification Numbers found in a number of ISBT 128 data structures.

 

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

This document 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.

 

IG-039 Implementation Guide: Global Registration Identifier for Donors Issuing Organization Number v1.0.0  PDF

The purpose of this document is to provide guidance for the use of the Global Registration Identifier for Donors (GRID) Issuing Organization Number (ION). This guidance provides instruction on how to obtain an ION, the structure of the ION database, and how to update GRID ION information within the ION database.

 

IG-040 Implementation Guide: Use of ISBT 128 in North American Eye Banks v1.3.0 - PDF

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The purpose of this document is to provide guidance to North American eye banks accredited by the Eye Bank Association of America (EBAA) in the implementation of ISBT 128. It is a joint document of the EBAA and ICCBBA.

 

IG-041 Implementation Guide: Use of ISBT 128 in Resource-Limited Countries v1.0.0 – PDF

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.

 

IG-042 Implementation Guide: Revised Bone Tissue Terminology v1.0.0 – PDF

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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.