Written and maintained by CASRAI Editorial Board
Last updated
This page describes products and general use; it is not medical advice.
Medical device labeling symbols are small pictograms printed on packages and labels that replace a sentence of text. The ones most people look up are the sterile symbol, the sterilization-method symbols and the single-use symbol. This page explains what each one says, how they differ, and when a US label may show a symbol without any words beside it.
Who uses it: clinic and hospital staff who open device packages, buyers and receiving staff who check labels, and students learning to read device labeling.
What these symbols are
Most of the symbols below come from the ISO 15223-1 family of medical device symbols. One manufacturer’s published symbols glossary (CooperSurgical, checked 2026-10-30) lists each symbol with its ISO 15223-1 reference number and an explanatory sentence, and the tables here follow that glossary’s wording. The reference numbers are the glossary’s own and can differ between editions of the standard, so check them against the edition in force before citing them. For the standard itself, see our overview of ISO 15223-1. Related symbols are covered in date of manufacture symbol, lot number and Rx only symbol.
Sterile symbol and sterilization symbols
What does the sterile symbol mean? It indicates a medical device that has been subjected to a sterilization process (reference 5.2.1 in the manufacturer glossary). The sterile symbol on its own states that sterilization was carried out; the method-specific symbols below name how.
What do the sterilization symbols mean? Each one names the process used for that device, as the glossary words it.
| Symbol title | Glossary ref. no. (ISO 15223-1) | Glossary wording | Key difference |
|---|---|---|---|
| Sterile | 5.2.1 | A device that has been subjected to a sterilization process. | General statement; does not name the method. |
| Sterilized using aseptic processing techniques | 5.2.2 | A device manufactured using accepted aseptic techniques. | Aseptic manufacturing rather than a sterilization step named below. |
| Sterilized using ethylene oxide | 5.2.3 | Sterilized using ethylene oxide. | Names ethylene oxide. |
| Sterilized using irradiation | 5.2.4 | Sterilized using irradiation. | Names irradiation. |
| Sterilized using steam or dry heat | 5.2.5 | Provided sterile and sterilized using steam or dry heat. | Names steam or dry heat. |
| Sterile fluid path | 5.2.9 | A sterile fluid path is present, though other parts, including the exterior, might not be supplied sterile. | Only the fluid path is sterile. |
| Sterilized using vaporized hydrogen peroxide | 5.2.10 | Sterilized using vaporized hydrogen peroxide. | Names vaporized hydrogen peroxide. |
| Single sterile barrier system | 5.2.11 | A single sterile barrier system. | Describes the packaging, not the method. |
| Non-sterile | 5.2.7 | A device that has not been subjected to a sterilization process. | The opposite of the sterile symbol. |
Single-use and reuse symbols
What does the single use symbol mean? The “Do not re-use” symbol (reference 5.4.2) indicates a medical device intended for one single use only. The glossary also lists a separate “Single patient-multiple use” symbol (5.4.12) for a device that may be used multiple times (multiple procedures) on a single patient.
| Symbol title | Glossary ref. no. (ISO 15223-1) | Glossary wording | Key difference |
|---|---|---|---|
| Do not re-use (single use) | 5.4.2 | Intended for one single use only. | One use. |
| Single patient-multiple use | 5.4.12 | May be used multiple times (multiple procedures) on a single patient. | Several uses, one patient only. |
| Do not resterilize | 5.2.6 | Not to be resterilized. | A statement about resterilization, separate from the use count. |
| Do not use if package is damaged and consult instructions for use | 5.2.8 | Should not be used if the package has been damaged or opened; consult the instructions for use. | Points the user to the instructions for use. |
When a US label may show a symbol alone
Under 21 CFR 801.15(c)(1)(i), a symbol may appear with adjacent explanatory English text. It may appear without text in two cases: when it is contained in a standard FDA recognizes under section 514(c) and is used as that recognition specifies, or when it is established in a standard from a standards development organization and the manufacturer determines it is likely to be read and understood by the ordinary individual under customary conditions of purchase and use. In both cases the symbol must be explained in a paper or electronic symbols glossary in the device labeling, and the package must carry a prominent and conspicuous statement saying where that glossary is. Symbols that do not meet these requirements render a device misbranded under section 502(c) of the act.
A symbols glossary lists each standard-established symbol used, the title and designation number of its standard, the symbol’s title and reference number, and its meaning. The unique device identifier carrier is a separate labeling element; see unique device identification.
Reading a label before use
- Find the sterile or non-sterile symbol first: they state opposite things.
- If a method symbol is present, read it as naming the process, not as an instruction.
- Check for the damaged-package symbol and the symbol directing you to the instructions for use; the glossary says to consult the instructions for use.
- Look at the use-count symbol: single use and single patient-multiple use are different statements.
- Use the symbols glossary named on the package when a symbol is unfamiliar.
Common mistakes
- Treating “single use” and “single patient-multiple use” as the same symbol; the glossary words them differently.
- Reading the sterile symbol as naming a method. Only the method symbols do that.
- Confusing the sterile barrier symbols (5.2.11) with sterilization method; they describe the barrier system.
- Assuming a symbol is self-explanatory. On a US label a symbol shown alone must be explained in the labeling glossary.
FAQ
What does the sterile symbol mean?
It indicates a medical device that has been subjected to a sterilization process (5.2.1 in the glossary above).
What do sterilization symbols mean?
They name the process used, such as ethylene oxide (5.2.3), irradiation (5.2.4), steam or dry heat (5.2.5) or vaporized hydrogen peroxide (5.2.10).
What does the single use symbol mean?
The “Do not re-use” symbol (5.4.2) indicates a device intended for one single use only.
Sources
- CooperSurgical, symbols glossary (ISO 15223-1 reference numbers and explanatory text): https://www.coopersurgical.com/symbols_glossary/, checked 2026-10-30. This is one manufacturer’s glossary, not the standard text.
- 21 CFR 801.15, Medical devices; prominence of required label statements (symbols): https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801/subpart-A/section-801.15 and https://www.law.cornell.edu/cfr/text/21/801.15, checked 2026-10-30.
