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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Protected against solid foreign objects of 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 isl packaging of a medical device.

Association for the Advancement of Medical Instrumentation

Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure. Do not reuse Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure.

Indicates the presence of a sterile fluid path within the medical device in cases when other parts of the medical device, including the exterior, might not be supplied sterile.

Read all warnings and precautions in instructions for use Indicates the need for the user free 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. Indicates the range of atmospheric pressure to which the medical device can be safely exposed.

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Non-pyrogenic Indicates a medical device that is non-pyrogenic. 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. ISO Codes for the representation of names of countries and their subdivisions — Part 1: To indicate generally elevated, potentially hazardous, levels of nonionizing radiation, or to indicate equipment or systems e.

fre The insistence on wording was argued to be required in order to avoid doubt as to the meaning of the symbol. To identify a foot switch or the connection kso a foot switch. Catalogue or model number Indicates the manufacturer’s catalogue number so that the medical device can be identified. Indicates the Authorized Representative in the European Community. To identify a type B applied part complying with IEC Complies with Industry Canada Radio communication requirements.

Medical device that has been demonstrated to pose no known hazards in a specified MR environment with specified conditions of use. The temperature is indicated adjacent to the upper horizontal line.

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, Ido and the Asia Pacific.

This is really a catch up for the rest of devices. Indicates the upper and lower limits of temperature to which the medical device can be safely exposed.

iwo ISOMedical Devices – Symbols to be used with medical device labels, labeling and information to be supplied — Part 1: Choose your Region Are you sure you want to proceed? Keep dry Indicates a medical device that needs to be protected from moisture.

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Authorized European representative Indicates the Authorized representative in the European Community.

EN ISO – Medical devices – Symbols to be used with medical device lab –

Indicates a medical device that is non pyrogenic. Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure.

Rfee the manufacturer’s serial number so that a specific medical device can be identified. Protected against the effects of continuous immersion in water. Indicates that the product is ftee medical device as defined in 21 CFR CE marking Signifies European free conformity. Indicates the manufacturer’s serial number so that a specific medical device can be identified.

Date of manufacture Indicates the date when the medical device was manufactured. Indicates the lower limit of temperature to which the medical device can be safely exposed. Indicates the upper limit of temperature to which the medical device can be safely exposed.

FDA has made it clear that manufacturers can continue as usual with currently valid labelling, words and all. Not all products are approved in all regulatory jurisdictions.

IEC Graphical symbols for use on equipment. Sterilized by ethylene oxide treatment Indicates a medical device that has been sterilized using ethylene oxide.

This is no symbolic gesture.