ISO 10993-4 Biological evaluation of medical devices: selection of tests for interactions with blood; anticipated changes in the standard based upon the 2016 final draft international standard (FDIS)

For the ‘A’ and ‘C’ in ISACB, the ISO10993-4 guidance document is important because it defines general requirements and considerations for evaluating interactions of concern between cardiovascular medical devices and... [ view full abstract ]

For the ‘A’ and ‘C’ in ISACB, the ISO10993-4 guidance document is important because it defines general requirements and considerations for evaluating interactions of concern between cardiovascular medical devices and blood [1]. The document describes (1) classification of blood-contacting medical devices based upon intended use and duration of contact as defined in ISO 10993-12 [2], (2) fundamental principles and scientific bases behind various methods of evaluating interactions of devices with blood, and (3) a structured selection of tests for consideration based upon intended use and blood contact duration. In short, this standard is a guide for start-up companies, established industry, and regulatory agencies to assess the apparent pre-clinical blood compatibility of candidate cardiovascular devices and materials intended for human blood contact applications.

The foundation of ISO10993-4 has several sources [3,4]. However, since its inception in 2002, the document has received only minor revision. Over the past several years the revision of this document has involved review of hundreds of comments from around the world, with the FDIS recommended for formal approval in 2016. Concisely, the new document provides a simplified process flow diagram for high level planning decisions, a reduced and simplified table of example devices vs. testing categories for consideration, and a streamlined table of actual tests for consideration in each test category.

Importantly, the standard suggests more opportunities for meaningful in vitro testing to supplement or replace certain animal testing. More emphasis is also placed on the importance of testing blood contacting devices for impact on thrombosis [5,6].