Single sterile barrier system with protective packaging inside (dashed inner oval)
The standard’s wording, as the sources below reproduce it:
“Indicates a single sterile barrier system with protective packaging inside.”
ISO 15223-1:2021, 5.2.13
What it means for you
One sealed sterile layer (the solid oval) with an extra protective layer inside it (the dashed oval), such as a card or tray that stops the device piercing the pouch. The inner layer protects the device physically; it is not a second sterile barrier.
Whether a device is right for you is a question for your pharmacist, nurse or doctor.
- What it looks like
- A solid oval with a dashed 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
- solid oval with dashed inner oval; protective packaging inside
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 outside.
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 5.2.13 “Single sterile barrier system with protective packaging inside — Indicates a single sterile barrier system with protective packaging inside.” Checked 2026-09-28.
- Cook Medical: Glossary of standard symbols — ISO 15223-1 5.2.13 “Single sterile barrier system with protective packaging inside”, 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 inside” among the MDR sterile-packaging symbols. Checked 2026-09-28.
Plain-language parts are in our own words; quotations are the sources’ wording.