Medical Devices - Documents

This section consists of documents that pertain to HCT/P medical devices.

Click here for documents that pertain to tissue-specific products.

Click here to view an example implementation plan.


 

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

The purpose of this document is to provide requirements and guidance for the labeling of medical devices containing a human tissue or cellular component using the ISBT 128 Standard.

 

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.

 

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)

 

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.