ISO 15223-1 FREE PDF

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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Indicates the Authorized Representative in the European Community. Symbol for date of manufacture. This symbol is accompanied by a date.

Product Label Symbols | Cook Medical

Indicates the date after which the medical device is not to be used. Indicates the manufacturer’s batch code so that the batch or lot can be identified NOTE: Synonyms for “batch code” are “lot number” and “batch number”. Indicates the manufacturer’s catalog number so that the medical device can be identified NOTE: Synonyms for “catalogue number” are “reference number” and “reorder number”.

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Indicates the manufacturer’s serial number so that a specific medical device can be identified. Indicates a medical device that has been subjected to a sterilization process.

Indicates a medical device that has been manufactured using accepted aseptic techniques. Indicates a medical device that has been sterilized using ethylene oxide. Indicates a medical device that has been sterilized using irradiation.

Indicates a medical device that is not to be resterilized. Indicates a medical device that has not been subjected to a sterilization process.

Indicates a medical device that should not be used if the package has been damaged or opened. Indicates the presence of a sterile fluid fref within the medical device in cases when other parts of the medical device, including the exterior, might not be supplied sterile.

Indicates a medical device that needs protection from light sources. Indicates a medical device that needs to be protected from moisture. Indicates the lower limit of temperature to which the medical device can be safely exposed. Indicates the upper limit of temperature to which the medical device can be safely exposed.

Indicates the temperature limits to which the medical device can be safely exposed. Indicates the ixo of atmospheric pressure to which the medical device can dree safely exposed. Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure.

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This is no symbolic gesture. FDA Final Rule on device label symbols – Brandwood:Biomedical

Indicates the need for the user to consult the instructions for use. Indicates the need for the user to 1522-1 the instructions for use for important cautionary information such as warnings and precautions that cannot, for a lso of isl, be presented on the medical device itself.

Indicates the presence of natural rubber latex or dry natural rubber latex as a material of construction within the medical device or the packaging of a medical device. Indicates a medical device that is non pyrogenic.

An item with demonstrated safety in the MR environment within defined conditions. An item which poses unacceptable risks to the patient, medical staff or other persons within the MR environment. To indicate that the equipment contains the identified product or substance.

Product Label Symbols

To identify a type B applied part complying with IEC To identify a foot switch or the connection for a foot switch. To identify the switch or switch jso by means of which part of the equipment is switched on in order to bring it into the stand-by condition.

To indicate on the rating plate that the equipment is suitable for alternating current only; to identify relevant terminals.