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 batch code so that the batch or lot can be identified NOTE: 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 lower limit oso temperature to which the medical device can be safely exposed. ASTM F Standard practice for marking medical devices and other items for safety in the magnetic resonance environment.
You will be leaving the Cook Medical website that you were viewing and going to a Cook Medical website for another region or country. Not all products shown on this website may be approved in all regulatory jurisdictions. Non-pyrogenic Indicates a medical device that is non-pyrogenic.
Manufacturer-determined degree of particle and water ingress protection, where Use by Indicates the date after which the medical device is not to be used. Codes for the representation of names of countries and their subdivisions — Part 1: Frde Final Rule on device label symbols.
Association for the Advancement of Medical Instrumentation
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 ido. Consult instructions for use Indicates the need for the user to consult the instructions for use.
The product information on these websites is intended only for licensed physicians and healthcare professionals. Symbol for use in the labelling of medical devices. Indicates a medical device that is not to be resterilized.
FDA has ieo it clear that manufacturers can continue as usual with currently valid labelling, words and all. Instead, the explanations may iao 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 upper limit of temperature to which the medical device can be safely exposed.
This symbol is accompanied by a date.
This is no symbolic gesture. FDA Final Rule on device label symbols – Brandwood:Biomedical
Indicates the temperature limits to which the medical device can be safely exposed. Symbol for date of manufacture. The requirements for accreditation and market surveillance relating to the marketing of products; Medical Device Directive. Indicates that the instructions for use contain important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself. Indicates a type B applied part complying with relevant section of the technical standard IEC for safety of medical electrical equipment.
Synonyms for “batch code” are “lot number” and “batch number”. ISOMedical Devices – Symbols to be used with medical device labels, labeling and information to be supplied — Part 1: Fragile, handle with care Indicates a medical device that can be broken or damaged if not handled carefully.
Indicates the manufacturer’s catalogue number so that the medical device can be identified. To indicate that the equipment contains the identified product or substance. ENClause 4. Indicates a medical device that sio intended for one use, or for use on a single patient during a single procedure.
Symbol Glossary Definitions
Indicates that natural rubber latex was not used in the manufacturing of the product, its container, or its packaging. Indicates the range of atmospheric pressure to which the medical device can be safely exposed. Come 13 September, manufacturers bringing forward new regulatory submissions can prepare draft labelling using symbols only as per the new rule.
Medical device that has been demonstrated to pose no known hazards in a specified MR environment with specified conditions of use. Indicates a medical device that is intended to be used as an in vitro diagnostic medical device.