Source: https://ormco.com/symbols/
Timestamp: 2020-05-29 00:05:18
Document Index: 480596672

Matched Legal Cases: ['art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1']

Symbols Glossary Definition | Ormco Supplies
Symbols Derived from Standards
ISO 15223-1, Reference 5.1.1 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements. Manufacturer Indicates the medical device manufacturer.
ISO 15223-1, Reference 5.1.2 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements. Authorized representative in the European Community Indicates the Authorized representative in the European Community.
ISO 15223-1, Reference 5.1.3 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements. Date of manufacture Indicates the date when the medical device was manufactured.
ISO 15223-1, Reference 5.1.4 Medical devices — Symbols to be used with medical device labels, labelling 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, Reference 5.1.5 Medical devices — Symbols to be used with medical device labels, labelling 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 5.1.6 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements. Catalogue number Indicates the manufacturer's catalogue number so that the medical device can be identified.
ISO 15223-1, Reference 5.1.7 Medical devices — Symbols to be used with medical device labels, labelling 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 5.2.1 Medical devices — Symbols to be used with medical device labels, labelling 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 5.2.3 Medical devices — Symbols to be used with medical device labels, labelling 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 5.2.4 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements. Sterilized using irradiation Indicates a medical device that has been sterilized using irradiation.
ISO 15223-1, Reference 5.2.7 Medical devices — Symbols to be used with medical device labels, labelling 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, Reference 5.2.8 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements. Do not use if package is damaged Indicates a medical device that should not be used if the package has been damaged or opened.
ISO 15223-1, Reference 5.3.2 Medical devices — Symbols to be used with medical device labels, labelling 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 5.3.5 Medical devices — Symbols to be used with medical device labels, labelling 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 5.3.6 Medical devices — Symbols to be used with medical device labels, labelling 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 5.3.7 Medical devices — Symbols to be used with medical device labels, labelling 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 5.4.2 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements. Do not reuse Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure.
ISO 15223-1, Reference 5.4.3 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements. Consult instructions for use Indicates the need for the user to consult the instructions for use.
ISO 15223-1, Reference 5.4.3 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements. Consult electronic instructions for use Indicates the need for the user to consult the electronic instructions for use (eIFU) at the specified website location.
ISO 15223-1, Reference 5.4.4 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements. 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.
ISO 15223-1, Reference 5.4.5 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements. Contains or presence of natural rubber latex Indicates the presence of natural rubber or dry natural rubber latex as a material of construction within the medical device or the packaging of a medical device.
ISO 15223-1, Reference 5.7.1 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements. Patient number Indicates a unique number associated with an individual patient.
ISO 7010, Reference W021 Graphical symbols — Safety colours and safety signs — Registered safety signs Warning; Flammable material To warn of flammable material.
ISO 7010, Reference W023 Graphical symbols — Safety colours and safety signs — Registered safety signs Warning; Corrosive substance To warn of corrosive substance.
Symbols Not Derived from Standards
21 CFR 801.109 Labeling; Prescription devices Prescription use only Caution: Federal law (USA) restricts this device to sale by or on the order of a licensed healthcare practitioner.
MDD 93/42/EEC Annex II; MDR 2017/745 Annex V The requirements for accreditation and market surveillance relating to the marketing of products; Medical Device Directive and Medical Device Regulation. European conformity European conformity (CE) mark for Class I medical devices.
MDD 93/42/EEC Annex II; MDR 2017/745 Annex V The requirements for accreditation and market surveillance relating to the marketing of products; Medical Device Directive and Medical Device Regulation. European conformity European conformity (CE) mark with Notified Body identification number for Class Im, Ir, Is, IIa, IIb, III medical devices Notified Body No. 0086: BSI, United Kingdom
MDD 93/42/EEC Annex II; MDR 2017/745 Annex V The requirements for accreditation and market surveillance relating to the marketing of products; Medical Device Directive and Medical Device Regulation. European conformity European conformity (CE) mark with Notified Body identification number for Class Im, Ir, Is, IIa, IIb, III medical devices Notified Body No. 2797: BSI, Netherlands
MDR 2017/745 Annex 1 23.2(q) The requirements for indicating that a device is a medical device; Medical Device Regulation. Medical device Indicates that the device is a medical device.
N/A N/A Telephone receiver or handset Indicates the telephone contact number.