The Association for the Advancement of Medical Instrumentation adopted two standards—ISO 8638 and ISO 8637—designed to help manufacturers display information about their products so that users can make an informed decision about which product to choose.
ISO 8638 offers guidance on such products as hemodialyzers, hemodiafilters, and hemofilters, and ISO 8637 offers guidance on blood circuits.
With the adoption of these standards, users can compare products side by side, regardless of which manufacturer makes the product.
The standards also offer guidance for testing sterility, structural integrity, biological safety, and tubing compliance, among other features.
