Summary
While traditional medical devices will fall outside the scope of ISBT 128, there are some human tissues and cellular products that are regulated as a medical device rather than being regulated as a biologic. In cases where the primary product is of human origin (such as a tissue tendon or bone putty), but that product is attached to a non-human element or apparatus (such as a suture on the tendon, or a syringe applicator for the bone putty), then regulatory authorities may consider that ‘combination’ product as a medical device.
Related Technical Documentation
This document is a comprehensive description of the rules surrounding the use of ISBT 128 as well as guidance in the interpretation of these rules.
The purpose of this document is to provide standards and guidance for the coding and labeling of medical products of human origin (MPHO): blood, cellular therapy products, tissues, milk, and organs, as well as those plasma derivatives for which ABO is relevant.
The Standard Terminology document provides definitions to all ISBT 128 terminology. The document should be used in conjunction with the ISBT 128 Product Description Code Database.
The version number of the Standard Terminology document will coincide with the first two numbers of the version of the applicable ISBT 128 Product Description Code Database. For example, Version 7.86 of the Standard Terminology shall coincide with Version 7.86.x of the ISBT 128 Product Description Code Database.
This document provides a general introduction to the ISBT 128 Standard.
The purpose of this document is to discuss the concatenation function as outlined in the ISBT 128 Application Specification and its impact on the three major type of scanning devices: contact scanners (“wands,” “pens”), near-contact scanners (CCDs), and non-contact scanners (lasers, “guns” and non-contact CCDs).
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.
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.
This guidance should be used in conjunction with the latest version of the ISBT 128 Standard Technical Specification (ST-001), and the intended audience should already be familiar with the specifications of the Standard and have a comprehensive understanding of ISBT 128 data structures.
