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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This symbol is accompanied by a date. However the explanations no longer have to appear on labelling next to the symbol.
Sterilized using steam or dry heat Indicates a medical device that has been sterilized using steam or dry heat. Indicates a medical device that is intended for one use or for use on a single patient during a single procedure.
Atmospheric Pressure Indicates the range of atmospheric pressure to which the medical device can be safely exposed.
Complies with Industry Canada Radio communication requirements. Cruciallly FDA goes further than this. The black bar underneath the bin indicates goods that were placed on the market after 13 August To indicate on the rating plate that the equipment is suitable for alternating current only; to identify relevant terminals.
Indicates the lower limit of temperature to which the medical device can be safely exposed. To identify a foot switch or the connection for a foot switch. Symbol for date of manufacture. Codes for the representation of names of countries and their subdivisions — Part 1: ISO Codes for the representation of names of countries and their subdivisions — Part 1: Need help developing product labelling or FDA or other regulatory submissions.
Requirements for labelling of medical devices containing phthalates.
Fragile, handle with care Indicates a medical device that can be broken or damaged if not handled carefully. Indicates a medical device that has been subjected to a sterilization process. The requirements for accreditation and market surveillance relating to the marketing of products; Medical Device Directive.
All this is about to change as FDA finally embraces the use of stand alone standardised symbols. Authorized European representative Indicates the Authorized representative in the European Community. 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. Protected against the effects of temporary immersion in water.
Indicates a medical device that has been sterilized using irradiation.
Product Label Symbols
isk In vitro diagnostic medical device Indicates a medical device that is intended to be used as an in vitro diagnostic medical device. Indicates the lower limit of temperature to which the medical device can be safely exposed. ISOClause 5. Do not reuse Indicates a medical device fres is intended for one use, or for use on a single patient during a single procedure. Indicates a medical device that is non pyrogenic.
Medical electrical equipment — Part Synonyms for “catalogue number” are “reference number” and “reorder number”.
General requirements for basic safety and essential performance — Collateral standard: ISOMedical Devices – Symbols to be used with medical device labels, labeling and information to be supplied — Part 1: Indicates the range of atmospheric pressure to which the medical device can be safely exposed.
Indicates the manufacturer’s serial number so that a specific medical device can be identified. Storage humidity range Indicates the range of 1523-1 to which the medical device can be safely exposed. Sterilized by ethylene oxide treatment Indicates a medical device that has been sterilized using ethylene oxide.
Indicates a medical device that should 152233-1 be used if the package has been damaged or opened. Consult with your local Cook 1523-1, distribution company or customer support center for details.
Symbol Glossary Definitions
In the US, FDA have insisted that symbols are accompanied by words to describe their meaning, whereas most of the rest of the world 152223-1 been happy to use symbols alone.
An item with demonstrated safety in the MR environment within defined conditions. The insistence on wording was argued to be required in order to avoid doubt as to the meaning of the symbol. Catalogue or model number Indicates the manufacturer’s catalogue number so that the medical device can be identified.
ASTM F Standard practice for marking medical devices and other items for safety in the magnetic resonance environment. 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.
Jun 16, admin. Protected against solid foreign objects of 1. Not all products are approved in all regulatory jurisdictions. FDA has made it clear that manufacturers can continue as usual with currently valid labelling, words and all. Manufacturer Indicates the medical device manufacturer.