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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Storage temperature range Indicates the temperature limits to which the medical device can be safely exposed. IECTable D. Read all warnings and precautions in instructions for use 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. Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure.

Manufacturers will still have to explain the symbols. The temperature is indicated adjacent to the horizontal lines. The insistence on wording was argued to be required in order to avoid doubt as to the meaning of the symbol. Contains natural rubber or 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. Protected against solid foreign objects of 1.

Manufacturer-determined degree of particle and water ingress protection, where BS ENSymbol for use in the labelling of medical devices Requirements for labelling of medical devices containing phthalates as described in Section 4.

A manufacturing site is the facility where the product is produced, transformed, or assembled into a medical device. Indicates the manufacturing site of the device. This symbol is accompanied by a date.

ISOMedical Devices – Symbols to be used with medical device labels, labeling and information to be supplied — Part 1: Indicates the lower limit of temperature to which the medical device can be safely exposed.

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Indicates the presence of freee 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.

Jun 16, admin. Do not use if package is damaged Indicates a medical device that should not be used if the package has been damaged or opened. Come 13 September, manufacturers bringing forward new regulatory submissions can prepare draft labelling using symbols only as per the new rule.

Indicates a medical device that needs to be protected from moisture. A complete listing of the symbols used by Argon is below.

Indicates a medical device that has been manufactured using accepted aseptic techniques. Indicates the manufacturer’s catalogue number so that the medical device can be identified. Indicates a medical device that has been sterilized using ethylene oxide.

Use by Indicates the date after which the medical device is not to be used. 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 continuous immersion in water.

Indicates the upper and lower limits of temperature to which the medical device can be safely exposed. To identify a type B applied part complying with IEC Consult instructions for use Indicates the need for the user to consult the instructions for use. As described in Section 7.

EN ISO 15223-1:2016

ENClause 5. Indicates a medical device that should not be used if the package has been damage or opened. Instead, the explanations may now be provided in a separate glossary isp symbols, provided either printed glossary in the user manual or as a separate leaflet with the device or as an electronic glossary — which could mot easilty be maintained by publication on a web page with a link printed on the labelling.

TC Wrap Up Dec 13, Indicates the need for the user to consult the instructions for use. IEC Graphical symbols for electrical equipment in medical practice. All this is about to change as FDA finally embraces the use of stand alone standardised symbols.

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Indicates the manufacturer’s batch code so that the batch or 15223-1 can be identified NOTE: Indicates a medical device that should not be used if the package has been damaged or opened. 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. ASTM F Standard practice for marking medical devices and other items for safety 1522-31 the magnetic resonance environment.

ANSI/AAMI/ISO (PDF)

Indicates a medical device that should not be used if the package has been damaged or opened. The black bar underneath the bin indicates goods that were placed on the market after 13 August Sterilized using steam or dry heat Indicates a medical device that has been sterilized using steam or dry heat. Indicates the manufacturer’s serial number so that a specific medical device can be identified.

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 Graphical symbols for use on Equipment.

Keep dry Indicates a medical device that needs to be protected from moisture. Sterilized by ethylene oxide treatment Indicates a medical device that has been sterilized using ethylene oxide. The temperature is indicated adjacent to the upper horizontal line.

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. However the explanations no longer have to appear on labelling next to the symbol. Indicates the range of atmospheric pressure to which the medical device can be safely exposed.

Degree of Ingress Protection Provided by Enclosure Manufacturer-determined degree of particle and water ingress protection, where