Contains biological material of human origin (BIO with a person)
The standard’s wording, as the sources below reproduce it:
“Indicates a medical device that contains biological tissue, cells, or their derivatives, of human origin.”
ISO 15223-1:2021, 5.4.9 · ISO 7000-3700
What it means for you
Part of the device is made from donated human tissue or cells, or something derived from them, such as processed skin or bone.
Whether a device is right for you is a question for your pharmacist, nurse or doctor.
- What it looks like
- The rounded, point-down triangle with the letters BIO above a small standing figure.
- Where you see it
- Some tissue grafts, dermal matrices and bone products that are regulated as devices.
- Other names
- BIO person; human tissue; donor material
What it does not tell you
It does not name the tissue or say how it was screened or processed; the instructions for use do.
Often confused with
Indicates a medical device that contains biological tissue, cells, or their derivatives, of animal origin.
More symbols in “A rounded triangle”
Sources
ISO 15223-1 is a paid standard, so the wording above is quoted as 3 publishers’ public documents reproduce it. Each was fetched and read on the date shown:
- Boston Scientific: Symbols Glossary — ISO 15223-1 5.4.9 “Contains biological material of human origin — Indicates a medical device that contains biological tissue, cells, or their derivatives, of human origin.” Checked 2026-09-28.
- NE Scientific: Master Symbol Glossary (CTF-100011 Rev 01) — Shows the BIO-and-figure mark for reference no. 5.4.9 (ISO 7000-3700). Checked 2026-09-28.
- MedTech Europe: Use of Symbols to Indicate Compliance with the MDR, version 3.0 (November 2021) — Lists “Contains biological material of human origin (3700)”: “contains tissues or cells, or their derivatives, of human origin”. Checked 2026-09-28.
Plain-language parts are in our own words; quotations are the sources’ wording.