Single sterile barrier system with protective packaging outside (dashed outer oval)
The standard’s wording, as the sources below reproduce it:
“Indicates a single sterile barrier system with protective packaging outside.”
ISO 15223-1:2021, 5.2.14
What it means for you
One sealed sterile layer (the solid oval) inside an outer protective layer (the dashed oval), such as a dust cover or carton. The outer layer protects the sterile pack in transport; it is not itself sterile.
Whether a device is right for you is a question for your pharmacist, nurse or doctor.
- What it looks like
- A dashed oval with a solid oval inside it.
- 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
- dashed oval with solid inner oval; protective packaging outside
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 a single sterile barrier system with protective packaging inside.
More symbols in “Ovals”
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 5.2.14 “Single sterile barrier system with protective packaging outside — Indicates a single sterile barrier system with protective packaging outside.” Checked 2026-09-28.
- Cook Medical: Glossary of standard symbols — ISO 15223-1 5.2.14 “Single sterile barrier system with protective packaging outside”, same description. 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 with protective packaging outside” among the MDR sterile-packaging symbols. Checked 2026-09-28.
Plain-language parts are in our own words; quotations are the sources’ wording.