Manufacturer

Indicates the medical device manufacturer

ISO 15223-1 Reference no. 5.1.1

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

Authorized Representative in the European Community/ European Union

Indicates the authorized representative in the European Community / European Union

ISO 15223-1 Reference no. 5.1.2

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

Authorized Representative in Switzerland

Indicates the authorized representative in Switzerland

ISO 20417 Reference no. 6.1.2 (d)

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

Importer

Indicates the entity importing the medical device into the locale

ISO 15223-1 Reference no. 5.1.8

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

Distributor

Indicates the entity distributing the medical device into the locale

ISO 15223-1 Reference no. 5.1.9

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

Country of Manufacture

To identify the country of manufacture of products

ISO 15223-1 Reference no. 5.1.11

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

Do Not Re-use

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

ISO 15223-1 Reference no. 5.1.4

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

Date of Manufacture

Indicates the date when the medical device was manufactured

ISO 15223-1 Reference no. 5.1.3

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

Use-by Date

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

ISO 15223-1 Reference no. 5.1.4

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

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 Reference no. 5.1.5

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

Unique Device Identifier

Indicates a carrier that contains unique device identifier information

ISO15223-1 Reference no. 5.7.10

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

Medical Device

Indicates the item is a medical device

ISO15223-1 Reference no. 5.7.7

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

Catalogue number

Indicates the manufacturer’s catalog number so that the medical device can be identified

ISO 15223-1 Reference no. 5.1.6

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

Indicates the model number or type number of a product

Indicates the model number or type number of a product

ISO 15223-1 Reference no. 5.1.10

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

Serial Number

Indicates the manufacturer’s serial number so that a specific medical device can be identified

ISO 15223-1 Reference no. 5.1.7

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

Consult Instructions for Use or Consult Electronic Instructions for Use

Medical devices — Symbols to be used with information to be supplied by the manufactaIndicates the need for the user to consult the instructions for use urer – Part 1: General requirements

ISO 15223-1 Reference no. A.16

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

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 Reference no. 5.4.5

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

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 Reference no. Annex B (b.2)

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

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 Reference no. 5.2.8

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

Sterile

Indicates a medical device that has been subjected to a sterilization process

ISO 15223-1 Reference no. 5.2.1

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

Sterilized Using Irradiation

Indicates a medical device that has been sterilized using irradiation

ISO 15223-1 Reference 5.2.4

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

Non-Sterile

Indicates a medical device that has not been subjected to a sterilization process

ISO 15223-1 Reference no. 5.2.7

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

Indicates a single sterile barrier system with protective packaging inside

ISO 15223-1 Reference no. 5.2.13

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

Single Sterile Barrier System with Protective Packaging Outside

Indicates a single sterile barrier system with protective packaging outside

ISO 15223-1 Reference no. 5.2.14

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

Keep Away from Sunlight

Indicates a medical device that needs protection from light sources

ISO 15223-1 Reference no. 5.3.2

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

Keep Dry

Indicates a medical device that needs protection from moisture

ISO 15223-1 Reference no. 5.3.4

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

Temperature Limit

Indicates the temperature limits to which the medical device can be safely exposed

ISO 15223-1 Reference no. 5.3.7

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

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 Reference no. Annex V

REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

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

The Medical Devices Regulations 2002

The Medical Devices Regulations 2002

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

Medical Devices Ordinance (MedDO) Reference no. Annex 5

Medical Devices Ordinance (MedDO)

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 Reference no 4.6 (b)

Medical gloves for single use – Part 3: Requirements and testing for biological evaluation