Symbol glossary

PAJUNK’s labelling is designed to meet all applicable international standards and regulations. Where possible, PAJUNK adopted the use of symbols to communicate requirements, product characteristics and provide guidance on handling and storage to the user. A compiled listing of symbols that may appear on the product labelling and the meaning of the symbol is provided in this document.

DATE OF MANUFACTURE

  • Indicates the date when the medical device was manufactured.
  • Reference: SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref no: 5.1.3

MANUFACTURER

  • Indicates the medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC.
  • Reference: SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref no: 5.1.1

CE-MARK

  • Indicates manufacturer declaration that the product complies with the essential/ general safety & performance requirements of the relevant European medical device, health, safety and environmental protection legislations.
  • European Medical Devices Directive 93/42/EEC of 14 June 1993 (as amended by Directive 2007/47/EC). European Medical Device Regulation 2017/745

CE-MARK WITH NOTIFIED BODY NUMBER

  • Indicates manufacturer declaration that the product complies with the essential/ general safety & performance requirements of the relevant European medical device, health, safety and environmental protection legislations.
  • European Medical Devices Directive 93/42/EEC of 14 June 1993 (as amended by Directive 2007/47/EC). European Medical Device Regulation 2017/745

PRESCRIPTION DEVICE

  • Indicates that the product is a medical device as defined in 21 CFR 820.3(l) and Federal Law (USA) restricts this device to sale by or on the order of a physician.
  • 21 CFR 801.109.

MEDICAL DEVICE

  • Indicates that the device is a medical device as defined in MDR 2017/745

BATCH CODE

  • Indicates the manufacturer’s batch code so that the batch or lot can be identified.
  • SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref no: 5.1.5

CATALOGUE ARTICLE NUMBER

  • Indicates the manufacturer’s catalogue number so that the medical device can be identified.
  • SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016. Ref no: 5.1.6

QUANTITY

  • Indicates the number of unit per package

UNIQUE DEVICE IDENTIFICATION

  • Indicates a carrier that contains unique device identifier information

USE-BY DATE

  • Indicates the date after which the medical device is not to be used.
  • Reference: SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref no: 5.1.4

DISTRIBUTOR

  • Indicates the entity distributing the medical device into the locale

STERILIZED USING ETHYLENE OXIDE

  • Indicates a medical device that has been sterilized using ethylene oxide.
  • SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref no: 5.2.3

DO NOT RE-STERILIZE

  • Indicates a medical device that is not to be re-sterilized.
  • SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref no: 5.2.6

DO NOT USE IF PACKAGE IS DAMAGED

  • Indicates a medical device that should not be used if the package has been damaged or opened.
  • SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref no: 5.2.8

SHARP OBJECTS

  • Taking care to avoid injury from sharp elements (e.g. needles, blades)

SINGLE STERILE BARRIER WITH PROTECTIVE PACKAGING

  • To indicate that there is a single sterile barrier system with protective packaging inside.
  • ISO 7000 Graphical symbols for use on equipment - Registered symbols. Ref no: 3708

DOUBLE STERILE BARRIER

  • To indicate that there is a double sterile barrier system.

SINGLE STERILE BARRIER

  • To indicate that there is a single sterile barrier system.
  • ISO 7000 Graphical symbols for use on equipment - Registered symbols. Ref no: 3707

KEEP AWAY FROM SUNLIGHT

  • Indicates a medical device that needs protection from light sources.
  • SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref no: 5.3.2

KEEP DRY

  • Indicates a medical device that needs to be protected from moisture.
  • SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref no: 5.3.4

TEMPERATURE LIMIT

  • Indicates the temperature limits to which the medical device can be safely exposed.
  • SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref no: 5.3.7

HUMIDITY LIMITATION

  • Indicates the range of humidity to which the medical device can be safely exposed.
  • SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref no: 5.3.8

ATMOSPHERIC PRESSURE LIMITATION

  • Indicates the range of atmospheric pressure to which the medical device can be safely exposed.
  • SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref no: 5.3.9

DO NOT RE-USE

  • Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure.
  • SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref. no: 5.4.2

CONSULT INSTRUCTIONS FOR USE

  • Indicates the need for the user to consult the instructions for use.
  • SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref. no: 5.4.3

CAUTION

  • Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself.
  • SS-EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements (ISO 15223-1:2016). Ref. no: 5.4.4

REFER TO INSTRUCTION MANUAL/BOOKLET

  • Follow instructions for use.
  • IEC 60601-1:2005/ COR1:2006 Medical electrical equipment — Part 1: General requirements for basic safety and essential performance. Table D.2, Symbol 10

TYPE BF APPLIED PART

  • To identify a type BF applied part complying with IEC 60601-1
  • IEC 60601-1, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance. Table D.1, Symbol 20

RECYCLE: ELECTRONIC EQUIPMENT

  • Identifies product that is subject to the European Union’s Waste Electrical and Electronic Equipment (WEEE) 2012/19/EU Directive for recycling of electronic equipment. The black bar underneath the bin indicates goods that are placed on the market after 13 August 2005.
  • Marking of electrical and electronic equipment in accordance with Article 11(2) of Directive 2002/96/EC (WEEE)

BOX CUTTER

  • Don't use box cutter

OPEN UP

  • Directions on how to open

INSTRUCTION

  • Provides the user with an activity / recommendation for action

INFORMATION

  • Gives the user supporting information

TRANSLATION

  • Indicates that the original medical device information has undergone a translation which supplements or replaces the original information

LATEX FREE

  • Not Manufactured with Natural Rubber Latex

PHTHALATE FREE

  • Indicates product that does not contain the phthalate plasticizer DEHP

PYROGEN FREE

  • Indicates a medical device that is non-pyrogenic

MR Conditional

  • An item with demonstrated safety in the MR environment within defined conditions including conditions for the static magnetic field, the time-varying gradient magnetic fields and the radiofrequency fields.

MR UNSAFE

  • An item which poses unacceptable risks to the patient, medical staff or other persons within the MR environment

NRFIT PRODUCT

  • Indicates product acc. to ISO 80369-6