Double sterile barrier system (two ovals)
The standard’s wording, as the sources below reproduce it:
“Indicates two sterile barrier systems.”
ISO 15223-1:2021, 5.2.12 · ISO 7000-3704
What it means for you
The device has two sealed sterile layers, one inside the other — for example a tray inside a pouch. In an operating theatre the outer layer is opened by one person and the inner one presented to the sterile field.
Whether a device is right for you is a question for your pharmacist, nurse or doctor.
- What it looks like
- Two plain ovals, one inside the other.
- 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
- two ovals; double sterile packaging; double pouch
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.
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 5.2.12 “Double sterile barrier system — Indicates two sterile barrier systems.” Checked 2026-09-28.
- Cook Medical: Glossary of standard symbols — ISO 15223-1 5.2.12 “Double sterile barrier system — Indicates two sterile barrier systems.” Checked 2026-09-28.
- MedTech Europe: Use of Symbols to Indicate Compliance with the MDR, version 3.0 (November 2021) — Lists “Double sterile barrier system (3704)” among the MDR sterile-packaging symbols. Checked 2026-09-28.
- Integra LifeSciences: Symbols Glossary (1410819-2 Rev B) — Shows two concentric ovals for 5.2.12: “Indicates two single sterile barrier systems.” Checked 2026-09-28.
Plain-language parts are in our own words; quotations are the sources’ wording.