ISO 10993-1 endpoints matrix

FAQ

How does the picker decide which endpoints to show?

It follows Table A.1 in Attachment A of FDA’s guidance “Use of International Standard ISO 10993-1” (issued September 8, 2023). You choose the nature of body contact (one of eight surface, externally communicating or implant categories) and the contact duration (limited, 24 hours or less; prolonged, more than 24 hours to 30 days; long-term, more than 30 days), and the picker lists the endpoints the table marks for that cell.

Is the endpoint list a checklist of tests to run?

No. FDA describes Attachment A as a framework for developing a biocompatibility evaluation, not a checklist for testing, and notes that particular devices may warrant more or fewer endpoints. Every endpoint the table marks should be addressed in the biological safety evaluation, through existing data, additional endpoint-specific testing, or a rationale for why the endpoint does not warrant additional assessment.

What is the difference between the ISO endpoints and the additional FDA endpoints?

In Table A.1, an X marks an ISO 10993-1:2018 recommended endpoint for consideration and an O marks an additional FDA-recommended endpoint for consideration. In the table, FDA adds material-mediated pyrogenicity for prolonged and long-term mucosal membrane contact. One X carries a footnote: genotoxicity for limited-duration externally communicating circulating blood contact applies to devices used in extracorporeal blood-contacting circuits. The picker shows these groups separately.

Why are pyrogenicity and subacute/subchronic toxicity handled the way they are?

ISO 10993-1:2018 identifies material-mediated pyrogenicity as a subset of acute systemic toxicity, but FDA advises considering a separate pyrogenicity evaluation, so the picker lists it on its own. ISO 10993-1:2018 has separate subacute and subchronic columns, while FDA’s table combines them and recommends choosing the test based on its duration compared with device use; for example, devices used for more than 14 days should not be assessed using a 14-day test.

Where do reproductive and developmental toxicity and degradation fit?

Table A.1 has columns for both but marks no specific cells. Its footnotes say reproductive and developmental toxicity should be addressed for novel materials, materials with a known reproductive or developmental toxicity, devices with relevant target populations (for example, pregnant women), or where device materials may be locally present in the reproductive organs, and that degradation information should be provided for devices, components or materials remaining in contact with tissue that are intended to degrade. The picker lists both as conditional for every category.

Which edition of ISO 10993-1 should we declare conformity to?

ISO lists ISO 10993-1:2025 (Edition 6, published November 2025) as current and ISO 10993-1:2018 as withdrawn. FDA has recognized the 2025 edition in part (recognition number 2-313) and will accept declarations of conformity to the 2018 edition until July 1, 2029. The X marks in FDA’s Table A.1 reflect ISO 10993-1:2018, so check category wording against the edition you declare conformity to.