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REGISTERED USERS - GUIDANCE DOCUMENTS

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

 

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 Implementation Guide: Use of Flags in the Donation Identification Number for Process Control of Critical Points during Processing and Distribution v1.0.2 – PDF

This document provides an overview of one way in which flag characters of the ISBT 128 Donation Identification Number [Data Structure 001] can be used for process control.

 

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

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-013 Implementation Guide: ISBT 128 Bar Codes: Valid and Invalid Examplesv1.1.0 – PDF

This document provides usable bar codes to help evaluate the operation of software when reading valid and invalid information. It is not intended to provide programming scripts for system configurations, but rather to test a system configuration.

 

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

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 v1.2.1 – PDF

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.

Illustrations provided in the document are formatted to provide clarity rather than as copy/paste examples for software development.

 

IG-017 Implementation Guide: Length of the Product Code Bar Code and Concatenation v1.1.0 – PDF

This document is a supplement to the ISBT 128 Standard Technical Specification. It provides specific guidance for bar code placement to allow for concatenation. This document also addresses concerns for printer setup of the Auto 128 feature.

 

IG-019 Implementation Guide: Manufacturer's Catalog Number and Lot Number (Items Other Than Containers) v1.0.1 – PDF

The purpose of this document is to provide guidance for the use of the Manufacturer and Catalog Number: Items Other Than Containers [Data Structure 021] and the Lot Number: Items Other Than Containers [Data Structure 022].

 

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

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

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

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] v1.2.0 – PDF

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

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

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

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

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

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

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

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 v1.2.0 – PDF

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] v1.2.0 - PDF

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

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-040 Implementation Guide: Use of ISBT 128 in North American Eye Banks v1.4.0 – PDF

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-043 Implementation Guide: A Validation Tool for ISBT 128 Data Structures v1.1.0 – PDF

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The purpose of this document is to provide a mechanism to validate software reading bar-coded labels. Regulatory and compliance staff, as well as software developers, may find this guidance document helpful when developing certain validation test plans.