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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Electromagnetic compatibility — Requirements and tests.

CE marking Signifies European technical conformity. TC Wrap Up Dec 13, IEC Graphical symbols for use on equipment. Sterilized by ethylene oxide treatment Indicates a medical device that has been sterilized using ethylene oxide. Indicates 152223-1 manufacturer’s catalog number so that the medical device can be identified NOTE: Medical device that has been ixo to pose no known hazards in a specified MR environment with specified conditions of use.

If all goes to plan the rule will be come effective in 90 days — on 13 September, Synonyms for “catalogue number” are “reference number” and “reorder number”. Indicates the manufacturer’s serial number so that a specific medical device can be identified. Batch code Indicates the manufacturer’s batch code so that the batch or lot fre be identified. Choose your Region Are you sure you want to proceed?

Storage humidity range Indicates the range of humidity to which the medical device can be safely exposed. Contact us to discuss how we can help you. Consult with your local Cook representative, distribution company or customer support center for details. To identify the switch or switch position by means of which part of the equipment is switched on in order to bring it into the stand-by condition.

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To identify a type B applied part complying with IEC Keep dry Indicates a medical device that needs to be protected from moisture. Indicates the range of atmospheric pressure to which the medical device can be safely exposed. Indicates a medical device that is intended for one use or for use on a single patient during a single procedure.

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

Do not reuse Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure. Protected against the effects of temporary immersion in water. The temperature is indicated adjacent to the upper horizontal line. Argon’s labeling is designed to meet the following standards: An item which poses unacceptable risks to the patient, medical staff or other persons within the MR environment.

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

Indicates the lower limit of temperature to which the medical device can be safely exposed.

Product Label Symbols | Cook Medical

ENClause 4. Need help developing product labelling or FDA or other regulatory submissions. The temperature is indicated adjacent to the horizontal lines. EN Graphical symbols for use on equipment. Cruciallly 15232-1 goes further than this.

Catalogue or model number Indicates the manufacturer’s catalogue number so that the medical device can be identified. The black bar underneath the bin indicates goods that were placed on the market after 13 August Indicates a medical device that is non pyrogenic.

Symbol Glossary Definitions

ISO Graphical symbols for use on equipment. All this is about to change as FDA finally frew the use of stand alone standardised symbols. ENClause 6. 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.

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Requirements for labelling of medical devices containing phthalates. Fragile, handle with care Indicates a medical device that can be broken or damaged if not handled carefully. The primary effect of the change is to allow a ffree to use standardised symbols in place of text on product labelling. IECTable D. Sterilized using irradiation Indicates a medical device that has been sterilized using irradiation.

Product subjected to a sterilization process Indicates a medical device that has been subjected to a sterilization process. Indicates the manufacturing site of the device. Synonyms for “batch code” are “lot number” and “batch number”. ASTM F Standard practice for marking medical devices and other items for safety in the magnetic resonance environment.

Indicates a medical device that needs protection from light sources. Indicates a medical device that has not been subjected to a sterilization process. Indicates the need for the user to consult the instructions for use. IEC Graphical symbols for electrical equipment in medical practice.

Symbol for date of manufacture. Indicates a medical device that has been sterilized using irradiation. 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.