ISO 15223-1: 2021
Reference no. 5.1.1. (ISO 7000-3082)
Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements.
Manufacturer
Indicates the medical device manufacturer
ISO 15223-1: 2021
Reference no. 5.1.2
Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements.
Authorized Representative in the European Community
Indicates the authorized representative in the European Community / European Union
ISO 15223-1: 2021
Reference no. 5.1.3. (ISO 7000-2497)
Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements.
Date of manufacture
Indicates the date when the medical device was manufactured
ISO 15223-1: 2021
Reference no. 5.1.4. (ISO 7000-2607)
Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements.
Use by date
Indicates the date after which the medical device is not to be used
ISO 15223-1: 2021
Reference no. 5.1.5. (ISO 7000-2492)
Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements.
Batch code
Indicates the manufacturer’s batch code so that the batch or lot can be identified
ISO 15223-1: 2021
Reference no. 5.1.6. (ISO 7000-2493)
Reference no. 5.1.6. (ISO 7000-2493) Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements.
Catalogue number
Indicates the manufacturer’s catalog number
ISO 15223-1: 2021
Reference no. 5.1.7. (ISO 7000-2498)
Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements.
Serial number
Indicates the manufacturer’s serial number so that a specific medical device can be identified
ISO 15223-1: 2021
Reference no. 5.2.1. (ISO 7000-2499)
Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements.
Sterile
Indicates a medical device that has been subjected to a sterilization process
ISO 15223-1:2016
Reference no. 5.2.6.(ISO 7000- 2608)
Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements.
Do not resterilize
Indicates a medical device that is not to be resterilized
ISO 15223-1: 2021
Reference no. 5.2.7. (ISO 7000-2609)
Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements.
Non-sterile
Indicates a medical device that has not been subjected to a sterilization process
ISO 15223-1: 2021
Reference no. 5.3.2. (ISO 7000-0624)
Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements.
Keep away from sunlight
Indicates a medical device that has not been subjected to a sterilization process
ISO 15223-1: 2021
Reference no. 5.3.5. (ISO 7000-0534)
Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements.
Lower limit of temperature
Indicates a medical device that has not been subjected to a sterilization process
ISO 15223-1: 2021
Reference no. 5.3.6. (ISO 7000-0533)
Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements.
Upper limit of temperature
Indicates the upper limit of temperature to which the medical device can be safely exposed
ISO 15223-1: 2021
Reference no. 5.3.7. (ISO 7000-0632)
Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements.
Temperature limit
Indicates the temperature limits to which the medical device can be safely exposed
ISO 15223-1: 2021
Reference no. 5.3.8. (ISO 7000-2620)
Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements.
Humidity limitation
Indicates the range of humidity t which the medical device can be safely exposed
ISO 15223-1: 2021
Reference no. 5.2.8. (ISO 7000-2606)
Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied – 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: 2021
Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements.
Biological risks
To indicate a reference to substances that may be hazardous to men, animals, plants, or the environment based on biological activity (for example, holding a virus)
ISO 15223-1:2016E
Reference no. 5.4.2. (ISO 7000- 1051)
Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements.
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 15223-1:2016 and ISO 15223-1:2020 Reference no. 5.4.3. (ISO 7000-1641)
Reference no. 5.4.3. (ISO 7000-1641)
Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements.
Consult instructions for use or consult electronic instructions for use
Indicates the need for the user to consult the instructions for use
ISO 15223-1:2016
Reference no. A.15
Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements.
Consult instructions for use or consult electronic instructions for use
Indicates the need for the user to consult the electronic instructions for use
ISO 15223-1: 2021 Reference no. 5.4.4. (ISO 7000-0434A)
Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements.
Caution
To indicate that caution is necessary when operating the device or control close to where the symbol is placed, or to indicate that the current situation needs operator awareness or operator action in order to avoid undesirable consequences
ISO 15223-1: 2021
Reference no. 5.4.5. (ISO 7000, symbol 2025)
Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied – 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
REGULATION EU 2017/745 & REGULATION EU 2017/746
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
CE marking
‘CE marking of conformity’ or ‘CE marking’ 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
N/A
N/A
Prescription Use Only
Caution: Federal law (USA) restricts this device to sale by or on the order of a licensed healthcare practitioner.
ISO 7001
Public Information Symbol
Recycling
To indicate the location of a recycling bin or container.
ISO15223-1: 2021
Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements.
Unique device identifier
Indicates a carrier that contains unique device identifier information
ISO 15223-1
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied
Not made with natural rubber latex
Not made with natural rubber latex
ISO/DIS 15223- 1:2020(E) DRAFT Reference no. 5.7.7
Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements.
Medical device
Indicates the item is a medical device.
Yanimed is a brand of Yanimed LLC based in Delaware US. Under the brand name Yanimed we produce disposable protective gloves for medical and industrial use.
We are – the home of Medical Gloves.
