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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Association for the Advancement of Medical Instrumentation
Contact us to discuss how we can help you. IEC Graphical symbols for electrical equipment in medical practice. The temperature is indicated adjacent to the upper horizontal line. Indicates the Authorized Representative in the European Community. Choose your Region Are you sure you want to proceed? In the US, FDA have insisted isk symbols are accompanied by words to describe their meaning, whereas most of the rest of the world has been happy to use symbols dree.
Do not reuse Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure. ENClause 4. Indicates the need for the user to consult the instructions for use. Not all products are approved in all regulatory jurisdictions. Indicates a type B applied part complying with relevant section of the technical standard IEC for safety of medical electrical equipment.
For years, medical device manufacturers have had to take two approaches to labelling. General requirements for basic safety and essential performance.
Protected against solid foreign objects of 1. ISOMedical Devices – Symbols to be used with medical device labels, labeling and information to be supplied — Part 1: Manufacturer Indicates the medical device manufacturer. Open here To identify the location where the package can be opened and to indicate the method of opening it. Indicates a medical device that should not be used if the package has been damaged or opened.
Indicates a medical device that has not been subjected to a sterilization process.
Consult instructions for use Indicates the need for the user to consult the instructions for feee. Indicates the date after which the medical device is not to be used. Do not resterilize Indicates izo medical device that is not to be resterilized.
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.
To identify a foot switch or the connection for a foot switch. Manufacturers will still have to explain the symbols.
EN ISO – Medical devices – Symbols to be used with medical device lab –
Cruciallly FDA goes further than this. Indicates a medical device that has been subjected to a sterilization process. Indicates a medical device that has been manufactured using accepted aseptic techniques. Indicates the lower limit of temperature to which the medical device can be safely exposed. Keep dry Indicates a medical device that needs to be protected frer moisture.
The temperature is indicated adjacent to the horizontal lines. Indicates the manufacturing site fre the device. The product information on these websites is intended only for licensed physicians and healthcare professionals. To indicate generally elevated, potentially hazardous, levels of nonionizing radiation, or to indicate equipment or systems e.
Country of origin To identify the country of manufacture of products.
Product Label Symbols
Jun 16, admin. An item with demonstrated safety in the MR environment within defined oso. Indicates manufacturer declaration that the product complies frew the essential requirements of the relevant European health, safety and environmental protection legislation. Indicates the upper limit of temperature to which the medical device can be safely exposed. Serial number Indicates the frde serial number so that a specific medical device can be identified.
Do not use if package is damaged Indicates a medical device that should not be used if the package has been damaged or opened. 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.
Requirements for labelling of medical devices containing phthalates. Indicates the manufacturer’s batch code so that the batch or lot can be identified NOTE: