ISO 10993-4 and ISO 10993-12 Amendment 1 (2025) recognized by FDA
ISO 10993-4 covers selection of tests for interactions with blood; ISO 10993-12 covers sample preparation and reference materials for biological and chemical testing.
What changed?
Status: Recognized. FDA's database lists both standards 'including Amendment 1 (2025)'. We have not summarised amendment content; obtain the amendments from ISO.
Source: FDA Recognized Consensus Standards — ISO 10993 search