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Medical device symbol glossary

Click on each symbol or term to view further details.

Manufacturer

Explanation

Indicates the medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC

Standard Title

Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements

Standard Reference
- ISO 15223-1:2016 Ref no: 5.1.1
- FDA Recognition no: 5-117
- ISO 7000 Ref no: 3082
- FDA Recognition no 5-124
- EN 980, Clause 5.12
Batch Code

Explanation

Indicates the manufacturer’s batch code so that the batch or lot can be identified.

Standard Title

Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements

Standard Reference
- ISO 15223-1: 2016 Ref no: 5.1.5
- FDA Recognition no: 5-117
- ISO 7000 Ref no: 2492
- FDA Recognition no 5-124
- EN 980, Clause 5.4
Use-by Date

Explanation

Indicates the date after which the medical device is not to be used.

Standard Title

Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements

Standard Reference
- ISO 15223-1: 2016 Ref no: 5.1.4
- FDA Recognition no: 5-117
- ISO 7000 Ref no: 2607
- FDA Recognition no 5-124
- EN 980, Clause 5.3
Consult instructions before use

Explanation

Indicates the need for the user to consult the instructions for use

Standard Title

Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements

Standard Reference
- ISO 15223-1:2016 Ref no: 5.4.3
- FDA Recognition no: 5-117
- ISO 7000 Ref no: 1641
- FDA Recognition no 5-124
- EN 980, Clause 5.18
QR Code

Explanation

Directs user to Resources

Standard Title

Information technology — Automatic identification and data capture techniques — QR Code 2005 bar code symbology specification

Standard Reference
- ISO/IEC 18004:2006
Recyclable

Explanation

Indicates the packaging is recyclable

Standard Title

Graphical symbols for use on equipment — Registered symbols

Standard Reference
- ISO 7001 – PI PF 066
- FDA Recognition no 5-124
Do not use if package information is damaged

Explanation

Indicates a medical device that should not be used if the package has been damaged or opened

Standard Title

Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements

Standard Reference
- ISO 15223-1 Ref no: 5.2.8
- FDA Recognition no: 5-117
- ISO 7000 Ref no: 2606
- FDA Recognition no 5-124
Prescription Only

Explanation

Caution: Federal law restricts this device to sale by or on the order of a contact lens prescriber

Standard Title

Labelling-Prescription devices. Indicates the product is a medical device as defined in 21 CFR 820.3(l) and contact lens prescriber as defined in 16 CFR 315.2

Standard Reference
- 21 CFR 801.109
- 21 CFR 801.15(c)(1)(i)F