Contains hazardous substances (CMR or endocrine disruptors)
The standard’s wording, as the sources below reproduce it:
“Indicates a medical device that contains substances that can be carcinogenic, mutagenic, reprotoxic (CMR), or substances with endocrine disrupting properties.”
ISO 15223-1:2021, 5.4.10 · ISO 7000-3723
What it means for you
Some part of the device contains a substance classed as carcinogenic, mutagenic or toxic to reproduction, or an endocrine disruptor, above 0.1 % by weight — most often the plasticiser DEHP in PVC tubing. EU rules (MDR Annex I 23.2(f)) require the label to show this, so that care for children and pregnant or breastfeeding patients can take it into account.
Whether a device is right for you is a question for your pharmacist, nurse or doctor.
- What it looks like
- The rounded, point-down triangle with a laboratory flask carrying an exclamation mark.
- Where you see it
- PVC tubing, bags and catheters (DEHP), some adhesives and electronic devices.
- Other names
- flask with ! in a triangle; CMR; endocrine disruptor; contains DEHP
What it does not tell you
It does not name the substance or say whether it is a risk for you; the instructions for use must name it and give any precautions.
More symbols in “A rounded 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:
- Boston Scientific: Symbols Glossary — ISO 15223-1 5.4.10 “Contains hazardous substances — Indicates a medical device that contains substances that can be carcinogenic, mutagenic, reprotoxic (CMR), or substances with endocrine disrupting properties.” Checked 2026-09-28.
- NE Scientific: Master Symbol Glossary (CTF-100011 Rev 01) — Shows the flask mark for reference no. 5.4.10 (ISO 7000-3723) with the same description. Checked 2026-09-28.
- MedTech Europe: Use of Symbols to Indicate Compliance with the MDR, version 3.0 (November 2021) — Lists “Contains hazardous substances (3723)” under MDR Annex I 23.2(f). Checked 2026-09-28.
Plain-language parts are in our own words; quotations are the sources’ wording.