Sterile
The standard’s wording, as the sources below reproduce it:
“Indicates a medical device that has been subjected to a sterilization process.”
ISO 15223-1:2021, 5.2.1 · ISO 7000-2499
What it means for you
The device went through a sterilisation process and is sterile until the pack is opened or damaged, up to the use-by date. When the method matters, makers use a variant with an extra cell (EO, R, A or a thermometer) instead.
Whether a device is right for you is a question for your pharmacist, nurse or doctor.
- What it looks like
- The word STERILE inside a rectangle, with no extra cell.
- Where you see it
- Sterile dressings, swabs, syringes, needles, catheters, surgical gloves and implants.
- Other names
- STERILE box
What it does not tell you
It does not promise the device is still sterile once the pack is opened, torn or wet, or after the hourglass date. It does not say the device can be re-sterilised.
Often confused with
Indicates a medical device that has not been subjected to a sterilization process.
More symbols in “The word STERILE”
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 5.2.1 “Sterile — Indicates a medical device that has been subjected to a sterilization process.” Image labelled ISO 7000-2499. Checked 2026-09-25.
- NE Scientific: Master Symbol Glossary (CTF-100011 Rev 01) — Shows STERILE in a box for reference no. 5.2.1 (ISO 7000-2499). Checked 2026-09-25.
- Cook Medical: Glossary of standard symbols — ISO 15223-1 5.2.1 “Sterile — Indicates a medical device that has been subjected to a sterilization process.” Checked 2026-09-25.
Plain-language parts are in our own words; quotations are the sources’ wording.