ISO identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices . Partie 1: Exigences générales. STANDARD. ISO. Permission can be requested from either ISO at the address below or ISO’s. ISO Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements.
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BS ENSymbol for use in the labelling of medical devices Requirements for labelling of medical devices containing phthalates as described in Section 4. Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied.
Indicates a medical device that needs io be protected from moisture. General requirements for basic safety and essential performance — Collateral standard: Manufacturer Indicates the medical device manufacturer. The product information on these websites is intended only for licensed physicians and healthcare professionals.
Serial number Indicates the manufacturer’s serial number so that a specific medical device can be identified.
Symbol Glossary Definitions
Indicates the need for the user to consult the instructions for use. This is no symbolic gesture. Indicates the lower limit of temperature to which the medical device can be safely exposed.
Indicates the manufacturer’s catalog number so that the medical device can be identified NOTE: As described in Section 7. Indicates a medical device that should not 51223-1 used if the package has been damage or opened. An item with demonstrated safety in the MR environment within defined conditions.
This symbol is accompanied by a date.
Association for the Advancement of Medical Instrumentation
Requirements for labelling of medical devices containing phthalates. Open here To identify the location where the package can be opened and to indicate the method of opening it. All this is about to change as FDA finally embraces the use of stand alone standardised symbols. 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 which may cause allergic reactions.
Consult with your local Cook representative, distribution company or customer support center for details. Indicates the date after which the medical device is not to be used.
Instead, the explanations may now be provided in a separate glossary of symbols, provided either printed glossary in the user manual or as a separate leaflet with the device or jso an electronic glossary — which could mot easilty be maintained by publication on a web page with a link printed on the labelling.
FDA Final Rule on device label symbols. Jun ido, admin. Protected against the effects of temporary immersion in water. In the US, FDA have insisted that symbols are accompanied by words to describe their meaning, whereas most of the rest of the world has been happy to use symbols alone.
Symbol Glossary Definitions
Indicates a medical device that has not been subjected to a sterilization process. Codes for the representation of names of countries and their subdivisions — Part 1: ISO Graphical symbols 152231- use on equipment. Storage humidity range Indicates the range of humidity to which the medical device can be safely exposed.
Medical electrical equipment — Part CE marking Signifies European technical conformity.
To indicate that the equipment contains the identified product or substance. Click here for the full FDA recognised standards database. FDA has made it clear that manufacturers can continue as usual with currently valid labelling, words and all.
An item which poses unacceptable risks to the patient, medical staff or other persons within the MR environment. Symbol for date of manufacture. This is really a catch up for the rest of devices. To identify a type B applied part complying with IEC Argon’s labeling is designed to meet the following standards: Indicates the lower limit of temperature to which the medical device can be safely exposed. 15232-1