ISO 15223-1 FREE PDF

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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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Protected against the effects of temporary immersion in water. CE marking Signifies European technical conformity. To indicate that the equipment contains the identified product or substance. Synonyms for “catalogue number” are “reference number” and “reorder number”.

ISO Codes for the representation of names of countries and their subdivisions — Part 1: However the explanations no longer have to appear on labelling next to the symbol. 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.

IEC Part 1: Indicates the range of atmospheric pressure to which the medical device can be safely exposed. 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.

Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure. The primary effect of the change is to allow a manufacturer to use standardised symbols in place of text on product labelling. Degree of Ingress Protection Provided by Enclosure Manufacturer-determined degree of particle and water ingress protection, where Do not resterilize Indicates a medical device that is not to be resterilized.

FDA is introducing a change to its recognised standards list See list below to endorse the international medical devices labelling standard ISO as well as isso product specific labelling standards covering pacemakers, electrical equipment generally and symbols relating to MRI safety. Jun 16, admin. 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.

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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.

Association for the Advancement of Medical Instrumentation

Indicates the temperature limits to which the medical device can be safely exposed. Non-pyrogenic Indicates a medical device that is non-pyrogenic.

Protected against the effects of continuous immersion in water. Non sterile Indicates a medical device that has not been subjected to a sterilization process. 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 the manufacturer’s batch code so that the batch or lot can be identified NOTE: Manufacturer-determined degree of particle and water ingress protection, where The product information on these websites is intended only for licensed physicians and healthcare professionals.

Symbols Glossary

Medical device that has been demonstrated to pose no known hazards in a specified MR environment with specified conditions of use. Complies with Industry Canada Radio communication requirements. Instead, the explanations may now be provided in a separate glossary of symbols, provided either printed glossary in the user manual cree 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.

You will be leaving the Cook Medical website that you were viewing and going to a Cook Medical website for another region or country. IECTable D. Indicates that the product is a medical device as defined in 21 CFR Indicates that frre rubber latex was not used in the manufacturing of the product, its container, or its packaging. Indicates a medical device that needs protection from light sources. Use by Indicates the date after which the medical device is not to be used.

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

FDA Final Rule on device label symbols. Indicates the manufacturing site of the device. FDA has made it clear that manufacturers can continue as usual with currently valid labelling, words and all. Do not reuse Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure.

To identify the location where the package can be opened and to indicate the method of opening it.

Indicates the date after which the medical device is not to be used. ENClause 4. This product contains Di 2-ethlhexyl phthalate DEHP which has been shown to cause reproductive harm in male neonates, pregnant women carrying male fetuses, and peripubertal males. Manufacturers will still have to explain the symbols. The requirements for accreditation and market surveillance relating to the marketing of products; Medical Device Directive.

ios Sterilized using steam or dry heat Indicates a medical device that has been sterilized using steam or dry heat. ISO Graphical symbols for use on equipment.

Product Label Symbols | Cook Medical

An item with demonstrated safety in the MR environment within defined conditions. General requirements for basic safety and essential performance — Collateral standard: TC Wrap Up Dec 13, Indicates a medical device that needs to be protected from moisture.

To identify a type B applied part complying with IEC Indicates the Authorized Representative in the Jso Community. Indicates a medical device that has been subjected to a sterilization process. A manufacturing site is the facility where the product is produced, transformed, or assembled into a medical device.