Symbols Glossary

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SYMBOLS GLOSSARY

SYMBOL STANDARD REFERENCE STANDARD TITLE SYMBOL TITLE EXPLANATORY TEXT
ISO 15223- 1 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 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 20417 Reference no. 6.1.2 d Swissmedic’s Medical Device Ordinance (MedDO)  Authorised representative for Switzerland Swiss authorised representative Indicates the authorised representative in Switzerland
ISO 15223- 1 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
SO 15223- 1 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 Use-by date iso_grs_7000_2607 Use by date
ISO 15223- 1 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 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 so that the medical device can be identified ISO 15223 Catalogue number ISO 7000 Catalog number
ISO 15223- 1 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 Reference no. 5.1.8. (ISO 7000-3725) 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. 5.1.10 (IEC 60417-6050) Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements. Model number To identify the model number or type number of a product. In the application of this symbol, the model number or type number of the product should be accompanied with this symbol
ISO 15223-1 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 reuse 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 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. Operator's manual; operating instructions Indicates the need for the user to consult the instructions for use iso_15223 Consult instructions for use iso_grs_7000_1641 Operator's manual; operating instructions
ISO 7000 Reference no. 2794 Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements. Packaging unit To indicate the number of pieces in the package.
ISO 15223-1, Reference no. 5.7.7 EU MDR GSPR 23.2 (q) Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied Medical Device Regulation Annex 1 - General safety and performance requirements Medical device Indicates the item is a medical device.
ISO 15223-1 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 27185 -2011-05-09 ISO 7000 / IEC 60417 (ISO 7000-3079) Graphical symbols for use on equipment. Open here To identify the location where the package can be opened and to indicate the method of opening it.
N/A N/A Open with Hand Symbol
EU 2017-745 EU 2017-746 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 CE marking (43) ‘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.
UK Conformity assessed UK MDR 2002 N/A UKCA marking
Code of Federal Regulations, Title 21, Part 801 21 CFR Part 801.1(c)(1)(i)F 21 CFR Part 801.109 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 15223-1 Reference no. 5.3.1. (ISO 7000-0621) Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements. Fragile, handle with care Indicates a medical device that can be broken or damaged if not handled carefully
ISO 15223-1 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 needs protection from light sources
ISO 15223-1 Reference no. 5.3.4. (ISO 7000-0626) Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements. Keep away from rain Indicates a medical device that needs protection from moisture ISO 15223 Keep dry ISO 7000 Keep away from rain
ISO 15223-1 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 the lower limit of temperature to which the medical device can be safely exposed
ISO 15223-1 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 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 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 Reference no. 5.2.2. (ISO 7000-2500) Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements. Sterilized using aseptic processing techniques Indicates a medical device that has been manufactured using accepted aseptic techniques
ISO 15223-1 Reference no. 5.2.3. (ISO 7000-2501) Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements. Sterilized using ethylene oxide Indicates a medical device that has been sterilized using ethylene oxide.
ISO 15223-1 Reference no. 5.2.4 (ISO 7000-2502) Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements. Sterilized using irradiation To indicate that the device is provided sterile and has been sterilized using irradiation.
ISO 15223-1 Reference no. 5.2.5 (ISO 7000-2503) Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements. Sterilized using steam or dry heat To indicate that the device is provided sterile and has been sterilized using steam or dry heat.
ISO 15223-1 Reference no. 5.2.9 (ISO 7000-3084) Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements. Sterile fluid path To identify the presence of a sterile fluid path within the medical device when other parts of the medical device are not necessarily supplied sterile.
ISO 15223-1 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 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 To indicate that the device that is normally provided sterile in the same or similar packaging has not been sterilized.
ISO 15223-1 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 To indicate that the device must not be used if the package holding the device is damaged, for example on packaging of medical devices.
ISO 15223-1 Reference no. 5.2.11. (ISO 7000-3707) Medical Devices — Symbols to be used with medical device labels, labeling, and information to be supplied — Part 1: General requirements. Single sterile barrier system Indicates a single sterile barrier system.
ISO 15223-1 Reference no. (ISO 7000-3704) Medical Devices — Symbols to be used with medical device labels, labeling, and information to be supplied — Part 1: General requirements. Double sterile barrier system Indicates two sterile barrier systems.
ISO 15223-1 Reference no. 5.2.13. (ISO 7000-3708) Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements. Single sterile barrier system with protective packaging inside Indicates a single sterile barrier system with protective packaging inside.
ISO 15223-1 Reference no. (ISO 7000-3709) Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements. Single sterile barrier system with protective packaging outside To indicate that there is a single sterile barrier system with protective packaging outside.
ISO 7000 / IEC 60417 (ISO 7000-6043) IEC 60417 — Graphical Symbols for Use on Equipment Caution, sharp edges To indicate that the marked item contains sharp edges and should not be touched without taking care
ISO 15223-1 Reference no. 5.4.1. (ISO 7000-0659) 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)
IEC 60601-1 Ref no. Table D.2, Symbol 20 (ISO 7000 / IEC 60417-5333) IEC 60417 — Graphical Symbols for Use on Equipment Type BF applied part To identify a type BF applied part complying with IEC 60601-1.
ISO 7000 / IEC 60417 (ISO 7000-6414) IEC 60417 — Graphical Symbols for Use on Equipment WEEE; waste electrical and electronic equipment; crossed-out wheeled bin To indicate that separate collection for waste electric and electronic equipment (WEEE) is required.
ISO 15223-1 Ref no. 5.4.5. Contains XXX (ISO 7000- 2025) Medical devices ‐ Symbols to be used with medical device labels, labeling and information to be supplied Contains or presence of XXX On medical devices: to indicate that the equipment contains the identified product or substance.
ISO 7000 / IEC 60417 (ISO 7000 - 0622) Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied — Part 1: General requirements. Use no hooks To indicate that hooks shall not be used for handling the transport package.
ISO 15223-1 Reference no. 5.7.8. (ISO 7000-3728) Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied — Part 1: General requirements. Translation To identify that the original medical device information has undergone a translation which supplements or replaces the original information.
ISO 15223-1 Reference no. 5.7.9. (ISO 7000-3727) Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied — Part 1: General requirements. Repackaging To identify that a modification to the original medical device packaging configuration has occurred.
EC 60601-1 Reference no. Table D.2, Safety sign 10 (ISO 7010-M002) Medical electrical equipment — Part 1: General requirements. for basic safety and essential performance Refer to instruction manual/booklet To signify that the instruction manual/booklet must be read.
ISO 780:1997 Reference no. 0623 (ISO 7000-0623) Graphical symbols for use on equipment - registered symbols This way up To indicate correct upright position of the transport package.
IEC-TR-60878 Reference no. 1135 ISO 7000-1135 Graphic symbols for use on electrical equipment in a medical practice General symbol for recover/recyclable To indicate that the marked item or its material is part of a recovery or recycling process
N/A N/A Canadian and US Certification mark Products bearing this mark have been tested and certified in accordance with applicable US and Canadian electrical safety and performance standards
N/A N/A Prop 65 Warning Intended to help Californians make informed decisions about their exposures to specific chemicals
SIMBOLO TITOLO REFERENZA DESCRIZIONE
ISO 15223-1: 5.1. Fabbricazione
Produttore 5.1.1. Indica il produttore del dispositivo medico.
Simbolo 2 Rappresentante autorizzato nella Comunità europea 5.1.2. Indica il rappresentante autorizzato nella Comunità Europea / Unione Europea.