Contains sufficient for <n> tests (Σ)
The standard’s wording, as the sources below reproduce it:
“Indicates the total number of IVD tests that can be performed with the IVD medical device.”
ISO 15223-1:2021, 5.5.5 · ISO 7000-0518
What it means for you
The number next to the Σ is how many tests the kit or pack contains enough for — Σ 5 on a box of rapid tests, Σ 50 on a vial of glucose strips.
Whether a device is right for you is a question for your pharmacist, nurse or doctor.
- What it looks like
- A Greek capital sigma (Σ) inside a triangle that points down, with a number beside it — for example Σ 50.
- Where you see it
- Boxes of rapid tests, test-strip vials, reagent kits.
- Other names
- number of tests; sigma symbol; tests per kit
What it does not tell you
It does not count repeats or control runs you may need, and it is not a pack count of other items in the box.
Often confused with
Indicates a medical device that is intended to be used as an in vitro diagnostic medical device.
More symbols in “A triangle”
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:
- Stago: Glossary of symbols (520233-A_EN) — “Contains sufficient for <n> tests — Indicates the total number of IVD tests that can be performed with the IVD. NF EN ISO 15223-1, symbol #5.5.5.” Checked 2026-09-25.
- NE Scientific: Master Symbol Glossary (CTF-100011 Rev 01) — Shows Σ in a point-down triangle for reference no. 5.5.5 (ISO 7000-0518), “Indicates the total number of IVD tests that can be performed with the IVD medical device”. Checked 2026-09-25.
- BÜHLMANN Laboratories: Symbol glossary, version 03 (release date 2025-02-04) — “Indicates the total number of tests that can be performed with the medical device. The number of tests … shall appear adjacent to the symbol.” Checked 2026-09-25.
Plain-language parts are in our own words; quotations are the sources’ wording.