Biological risks (biohazard trefoil)
The standard’s wording, as the sources below reproduce it:
“Indicates that there are potential biological risks associated with the medical device.”
ISO 15223-1:2021, 5.4.1 · ISO 7000-0659
What it means for you
The device, or what it contains or collects, may carry infectious material — used lancets, sample tubes, test swabs and control materials made from human blood. Handle and dispose of it as the instructions say.
Whether a device is right for you is a question for your pharmacist, nurse or doctor.
- What it looks like
- Three interlocking open rings around a small central circle — the biohazard trefoil.
- Where you see it
- IVD kits and control materials, sample collection devices, sharps and waste containers.
- Other names
- biohazard; biological hazard
What it does not tell you
It does not name the organism or say how dangerous the material is, and it gives no disposal rule of its own.
Often confused with
To indicate that caution is necessary when operating the device or control close to where the symbol is placed, or to indicate that the current situation needs operator awareness or operator action in order to avoid undesirable consequences.
More symbols in “Warnings”
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 5.4.1 “Biological risks — Indicates that there are potential biological risks associated with the medical device.” Image labelled ISO 7000-0659. Checked 2026-09-25.
- NE Scientific: Master Symbol Glossary (CTF-100011 Rev 01) — Shows the biohazard trefoil for reference no. 5.4.1 (ISO 7000-0659). Checked 2026-09-25.
- Stago: Glossary of symbols (520233-A_EN) — “Biological risks — Indicates that there are potential biological risks associated with the medical device. NF EN ISO 15223-1, symbol #5.4.1.” Checked 2026-09-25.
Plain-language parts are in our own words; quotations are the sources’ wording.