Single sterile barrier system (one oval)
The standard’s wording, as the sources below reproduce it:
“Indicates a single sterile barrier system.”
ISO 15223-1:2021, 5.2.11 · ISO 7000-3707
What it means for you
The device is inside one sealed layer that keeps it sterile — typically one peel pouch or one sealed tray. Once that layer is opened or torn, nothing else is keeping the device sterile.
Whether a device is right for you is a question for your pharmacist, nurse or doctor.
- What it looks like
- One plain oval outline.
- Where you see it
- The outer box or peel pouch of sterile single-use devices and implants sold in the EU since the 2021 edition, usually near the STERILE and method marks.
- Other names
- one oval; single sterile packaging; SBS
What it does not tell you
It does not say the device is sterile (the STERILE box does that) or name the method, and it does not tell you how to open the pack; for aseptic opening follow the instructions for use.
Often confused with
Indicates two sterile barrier systems.
More symbols in “Ovals”
Sources
ISO 15223-1 is a paid standard, so the wording above is quoted as 4 publishers’ public documents reproduce it. Each was fetched and read on the date shown:
- Boston Scientific: Symbols Glossary — ISO 15223-1 5.2.11 “Single sterile barrier system — Indicates a single sterile barrier system.” Checked 2026-09-28.
- Cook Medical: Glossary of standard symbols — ISO 15223-1 5.2.11 “Single sterile barrier system — Indicates a single sterile barrier system.” Checked 2026-09-28.
- MedTech Europe: Use of Symbols to Indicate Compliance with the MDR, version 3.0 (November 2021) — Lists “Single sterile barrier system (3707)” among the MDR symbols, developed for MDR Annex I 23.3(a), “an indication permitting the sterile packaging to be recognised as such”. Checked 2026-09-28.
- NE Scientific: Master Symbol Glossary (CTF-100011 Rev 01) — Shows the single oval for reference no. 5.2.11 (ISO 7000-3707): “Indicates a single sterile barrier system.” Checked 2026-09-28.
Plain-language parts are in our own words; quotations are the sources’ wording.