Gloves, garments and other controlled-environment products often carry standard symbols on the product, box or label. This page explains what each symbol means and which standard defines it. Most come from ISO 15223-1, the international standard for symbols used with medical devices.
SYMBOL GLOSSARY
| Symbol | Symbol Name | Description | Standard |
|---|---|---|---|
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Manufacturer | Indicates the medical device manufacturer | ISO 15223-1 Ref. 5.1.1 |
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Authorized Representative in the European Community / European Union | Indicates the authorized representative in the European Community / European Union | ISO 15223-1 Ref. 5.1.2 |
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Authorized Representative in Switzerland | Indicates the authorized representative in Switzerland | ISO 20417 Ref. 6.1.2 (d) |
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Importer | Indicates the entity importing the medical device into the locale | ISO 15223-1 Ref. 5.1.8 |
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Distributor | Indicates the entity distributing the medical device into the locale | ISO 15223-1 Ref. 5.1.9 |
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Country of Manufacture | To identify the country of manufacture of products | ISO 15223-1 Ref. 5.1.11 |
Identifying the product
| Symbol | Symbol Name | Description | Standard |
|---|---|---|---|
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Date of Manufacture | Indicates the date when the medical device was manufactured | ISO 15223-1 Ref. 5.1.3 |
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Use-by Date | Indicates the date after which the medical device is not to be used | ISO 15223-1 Ref. 5.1.4 |
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Batch Code | Indicates the manufacturer's batch code so that the batch or lot can be identified. NOTE: Synonyms for “batch code” are “lot number”, “lot code” and “batch number”. |
ISO 15223-1 Ref. 5.1.5 |
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Unique Device Identifier | Indicates a carrier that contains unique device identifier information | ISO 15223-1 Ref. 5.7.10 |
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Medical Device | Indicates the item is a medical device | ISO 15223-1 Ref. 5.7.7 |
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Catalogue number | Indicates the manufacturer's catalog number so that the medical device can be identified | ISO 15223-1 Ref. 5.1.6 |
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Model Number | Indicates the model number or type number of a product | ISO 15223-1 Ref. 5.1.10 |
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Serial Number | Indicates the manufacturer's serial number so that a specific medical device can be identified | ISO 15223-1 Ref. 5.1.7 |
Use and safety
| Symbol | Symbol Name | Description | Standard |
|---|---|---|---|
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Do Not Re-use | Indicates a medical device that is intended for one single use only NOTE: Synonyms for “Do not reuse” are “single use” and “use only once”. |
ISO 15223-1 Ref. 5.4.2 |
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Consult Instructions for Use or Consult Electronic Instructions for Use | Indicates the need for the user to consult the instructions for use | ISO 15223-1 Ref. 5.4.3 |
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Consult Instructions for Use or Consult Electronic Instructions for Use | Indicates the need for the user to consult the instructions for use | ISO 15223-1 Ref. Annex A.16 |
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Contains or Presence of Natural Rubber Latex | Indicates the presence of dry natural rubber or natural rubber latex as a material of construction within the medical device or the packaging of a medical device | ISO 15223-1 Ref. 5.4.5 |
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Not Made with or Absence of Natural Rubber Latex | Indicates the absence of dry natural rubber or natural rubber latex as a material of construction within the medical device or the packaging of a medical device | ISO 15223-1 Ref. Annex B (B.2) |
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Do Not Use if Package is Damaged and Consult Instructions for Use | Indicates a medical device that should not be used if the package has been damaged or opened and that the user should consult the instructions for use for additional information | ISO 15223-1 Ref. 5.2.8 |
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Contains potential Type IV chemical allergens | For any medical glove where chemical ingredients such as accelerators, antioxidants and biocides are added during the manufacturing or already known to be present in the product and there is a residual risk of causing Type IV allergy | BS EN 455-3 Ref. 4.6 (b) |
Sterility
| Symbol | Symbol Name | Description | Standard |
|---|---|---|---|
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Sterile | Indicates a medical device that has been subjected to a sterilization process | ISO 15223-1 Ref. 5.2.1 |
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Sterilized Using Irradiation | Indicates a medical device that has been sterilized using irradiation | ISO 15223-1 Ref. 5.2.4 |
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Non-Sterile | Indicates a medical device that has not been subjected to a sterilization process | ISO 15223-1 Ref. 5.2.7 |
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Single Sterile Barrier System with Protective Packaging Inside | Indicates a single sterile barrier system with protective packaging inside | ISO 15223-1 Ref. 5.2.13 |
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Single Sterile Barrier System with Protective Packaging Outside | Indicates a single sterile barrier system with protective packaging outside | ISO 15223-1 Ref. 5.2.14 |
Storage
| Symbol | Symbol Name | Description | Standard |
|---|---|---|---|
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Keep Away from Sunlight | Indicates a medical device that needs protection from light sources | ISO 15223-1 Ref. 5.3.2 |
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Keep Dry | Indicates a medical device that needs protection from moisture | ISO 15223-1 Ref. 5.3.4 |
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Temperature Limit | Indicates the temperature limits to which the medical device can be safely exposed | ISO 15223-1 Ref. 5.3.7 |
Conformity marks
| Symbol | Symbol Name | Description | Standard |
|---|---|---|---|
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CE Marking | CE marking of conformity means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing | Regulation (EU) 2017/745 Ref. Annex V |
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UKCA Marking | UKCA marking of conformity means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements for products sold within Great Britain | UK Medical Devices Regulations 2002 |
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Swiss MD Marking | Swiss MD marking of conformity means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements for products sold within Switzerland | Swiss Medical Devices Ordinance (MedDO) Ref. Annex 5 |
Symbols are shown for reference. Always follow the symbols and instructions printed on the product packaging.
































