ISO 15223-2 PDF

Symbols to be used with medical device labels, labelling, and information to be supplied. Symbol development, selection and validation The ISO series of standards addresses symbols that can be used to convey information that is essential for the safe and proper use of medical devices. As such, in most regulatory domains the symbols are required to be presented with the device. The information can be required to be presented on the device itself, as part of the label or provided with the device.

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Tajinn Find Similar Items This product falls into the following categories. As with any risk control measure, the manufacturer needs to verify the effectiveness of the information for safety before it can be accepted.

As such, in most regulatory domains the symbols are required to be presented with the device. Some of ios best practices for symbols development and usage have been translated into normative requirements in ISO The information can be required to be presented on the device itself, as part of the label or provided with the device. Worldwide Standards We can source any standard from anywhere in the world. BS ISO is not restricted to symbols intended to meet regulatory requirements or specified in regulatory guidelines on labelling.

Symbol development, selection and validation The ISO series of standards addresses symbols that can be used to convey information that is essential for the safe and proper use of medical devices. Accept and continue Learn more about the cookies we use and how to change your settings. This website is best viewed with browser version of up Microsoft Internet Explorer 8 or Firefox 3.

General requirements Part 2: This presents problems to device manufacturers and users. Search all products by. Learn more about the cookies we use and how to change your settings. Bei Aufschriften von Medizinprodukten zu verwendende Symbole, Kennzeichnung und zu liefernde Informationen. When the processes detailed in this part of ISO have been carried out, the probability of misinterpretation of symbols accepted in ISO is reduced. In addition, some users and regulatory authorities have concerns that the unrestricted use of symbols without validation can represent a hazard.

You may experience issues viewing this site in Internet Explorer 9, 10 or This standard is in two partsunder the general title Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied: Your basket is empty.

It can also be used by manufacturers and regulators for validating symbols for use with medical devices, where they are not standardized. You may similar items within these categories by selecting from the choices below:. The series of standards addresses symbols that can be used to convey information that is essential for the safe and proper use of medical devices.

Entwicklung von Symbolen, Auswahl und Bewertung. Symbol development, selection and validation. The use of standardized symbols agreed by consensus on an international basis can address the confusion that users can experience when presented with labelling in a number of different languages. Symbols to be used with medical device labels, labelling, and information to be supplied.

If the symbol validation process detailed in BS ISO has been complied with, then the residual risks associated with the usability of a medical device symbol are presumed to be acceptable unless there is objective evidence to the contrary. However, the proliferation of symbols without control and harmonization is undesirable and detracts from the effectiveness of using symbols to convey information for safety.

We use cookies to make our website easier to use and to better understand your needs. ISO proposes solutions to these problems through the use of internationally recognized symbols, with precisely defined meanings, that are independent of language. This part of ISO includes methods for validating those candidate symbols being proposed for inclusion in ISO Take the smart route to manage medical device compliance.

Please download Chrome or Firefox or view our browser tips. Much of the information required on a medical device itself, as part of the label, or provided with the device constitutes information for safety within an integrated approach to risk management. TOP 10 Related.

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