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 manufacturer’s serial number so that a specific medical feee can be identified. Consult with your local Cook representative, distribution company or customer support center for details.

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 as an electronic glossary — which could mot easilty be maintained by publication on a web page with a link printed on the labelling. Indicates the manufacturer’s batch code so that the batch or lot can be identified NOTE: This is no symbolic gesture.

Protected against the effects of continuous immersion in water.

To identify the location where the package can be opened and to indicate the method of opening it. Non sterile Indicates a medical device that has not been subjected to a sterilization process.

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Indicates a medical device that needs protection from light sources. Indicates that the instructions for use contain important cautionary information such as warnings and precautions that cannot, ieo a variety of reasons, be presented on the medical device itself.

Indicates that the product is a medical device as defined in 21 CFR The following procedures have been identified as posing the greatest risk for DEHP exposure: Indicates a medical device that has not been subjected to a sterilization process. Click here for the full FDA recognised standards database.

Do not reuse Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure. You will be leaving the Cook Medical website that you were viewing and going to a Cook Medical website for another region or country.

TC Wrap Up Dec 13, Sterilized by ethylene oxide treatment Indicates a medical device that has been sterilized using ethylene oxide. For years, medical device manufacturers have had to take two approaches to labelling. 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. The requirements for accreditation and market surveillance relating to the marketing of products; Medical Device Directive.

Symbol Glossary Definitions

Indicates a medical device that should not be used if the package has been damaged or opened. The temperature is indicated adjacent to the lower horizontal line. Product subjected to a sterilization process Indicates a isp device that has been subjected to a sterilization process. Indicates a medical device 15223–1 should not be used if the package has been damaged or opened.

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Consult instructions for use Indicates the need for the user to consult the instructions for use. This symbol is accompanied by a date.

Jun 16, admin. Argon’s labeling is designed to meet the following standards: Indicates the manufacturer’s catalogue number so that the medical device can be identified. Indicates manufacturer declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation.

Storage humidity range Indicates the range of humidity to which the medical device can be safely exposed. Synonyms for “catalogue number” are “reference number” and “reorder number”.

ANSI/AAMI/ISO (PDF)

Use by Indicates the date after which the medical device is not to be used. Do not use if package is damaged 1523-1 a medical device that should not be used if the package has been damaged or opened.

Indicates a medical device that should not be used if the package has been damage or opened. Medical electrical equipment — Part Non-pyrogenic Indicates a medical device that is non-pyrogenic.

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