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.
|Published (Last):||28 April 2015|
|PDF File Size:||14.77 Mb|
|ePub File Size:||1.50 Mb|
|Price:||Free* [*Free Regsitration Required]|
An item which poses unacceptable risks to the patient, medical staff or other persons within the MR environment.
TC Wrap Up Dec 13, Indicates the manufacturer’s catalog number so that the medical device can be identified NOTE: This is really a catch up for kso rest of devices. FDA has made it clear that manufacturers can continue as usual with currently valid labelling, words and all. The black bar underneath the bin indicates goods that were placed on the market after 13 August Prescription only Requires prescription in the United States.
Indicates the manufacturer’s batch code so that the batch or lot can be identified NOTE: Batch code Indicates the manufacturer’s batch code so that the batch or lot can be identified. Sterilized using irradiation Indicates a medical device that has been sterilized using irradiation.
Indicates the need for the user to consult the instructions for use. The temperature is indicated adjacent to the lower horizontal line. This product contains Di 2-ethlhexyl phthalate DEHP which has sio shown to cause reproductive harm in male neonates, pregnant women carrying male fetuses, and peripubertal males. However the explanations no longer have to appear on labelling next to the symbol.
Codes for the representation of names of countries and their subdivisions — Part 1: Medical device that has been demonstrated to pose no known hazards in dree specified MR environment with specified conditions of use.
EN ISO – Medical devices – Symbols to be used with medical device lab –
To indicate generally elevated, potentially hazardous, levels of nonionizing jso, or to indicate equipment or systems e. Storage humidity range Indicates the range of humidity to which the medical device can be safely exposed.
To indicate that the equipment contains the identified product or substance. In vitro diagnostic medical device Indicates a medical device that is intended to be used as an in vitro diagnostic medical device. Come 13 September, manufacturers bringing forward new regulatory submissions can prepare draft labelling using symbols only as is the new rule. As described in Section 7. General requirements for basic safety and essential performance.
Indicates manufacturer declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation. Non-pyrogenic Indicates a medical device that is non-pyrogenic. To indicate on the rating plate that the equipment is suitable for alternating current only; to identify relevant terminals. Indicates the manufacturer’s serial number so that a specific medical device can be identified.
Symbol Glossary Definitions
ISO Graphical symbols for use on equipment. Atmospheric Pressure Indicates the range of atmospheric pressure to which the medical device can be safely exposed.
Not all products shown on this website may be approved in all regulatory jurisdictions. Indicates a type Fred applied part complying with relevant section of the technical standard IEC for safety of medical electrical equipment. The product information on these websites is intended only for licensed physicians and healthcare professionals.
On Extraction — the vagaries Dec 20, Indicates a medical device that should not be used if the package has been damaged or opened. Protected against solid foreign objects of To identify the location where the package can be opened and to indicate the method of opening it. The insistence on wording was argued to be required in order to avoid doubt as to the meaning of the symbol. Do not use if package is damaged Indicates a medical device that should not be used if the package has been ieo or opened.
Consult with your local Fdee representative, distribution company or customer support center for details. Contact us to discuss how we can help you. Product subjected to a sterilization process Indicates a medical feee that has been subjected to a sterilization process.
Symbol Glossary Definitions
ENClause 6. Electromagnetic compatibility — Requirements and tests. We take a global approach to regulatory compliance and have a track record of successful support to manufacturers and developers to obtain regulatory approvals in the USA, Europe and the Asia Pacific. Indicates the date after which the medical device uso not to be used.
EN ISO 15223-1:2016
Requirements for labelling of medical devices containing phthalates. Indicates a medical device that should not be used if the package has been damaged or opened. Not all products are approved in all regulatory jurisdictions. Protected against the effects of continuous immersion in water.