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ISO 15223-2 PDF

ISO /(R) Medical devices—Symbols to be used with medical device labels, labeling, and information to be supplied—. Part 2: Symbol. ANSI/AAMI/ISO /(R) Medical devices – Symbols to be used with medical device labels, labeling and information to be supplied – Part 2. Find the most up-to-date version of ISO at Engineering

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When the processes detailed in this part of ISO have been carried out, the probability of misinterpretation of symbols accepted in ISO is reduced.

ANSI/AAMI/ISO /(R)

Some of the best practices for symbols development and usage have been translated into normative requirements in ISO As with any risk control measure, the manufacturer needs to verify the effectiveness of the lso for safety before it can be accepted.

As 1522-2, in most regulatory domains the symbols are required to be presented with the device. This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. Find Similar Items This product falls into the following categories. Click to learn more.

Bei Aufschriften von Medizinprodukten zu verwendende Symbole, Kennzeichnung und zu liefernde Informationen. Learn more about the cookies we use and how to change your settings. ISO proposes solutions to these problems through the use of internationally recognized symbols, with precisely defined meanings, that are independent of language. 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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Please download Chrome or Firefox or view our browser tips. Entwicklung von Symbolen, Auswahl und Bewertung. 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. You may find similar items within these categories by selecting from the choices below:. 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.

Worldwide Standards We can source any standard from anywhere in the world. 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. Accept and continue Learn more about the cookies we use and how to change your settings.

General requirements Part 2: 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 iiso are presumed to be acceptable unless there is objective evidence to the contrary. Your basket is empty. 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: 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.

Symbols to be used with medical device labels, labelling, and information to be supplied. Symbol development, selection and validation Status: This part of ISO includes methods for oso those candidate symbols being proposed for inclusion in ISO This presents problems to device manufacturers and users.

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BS ISO is not restricted to symbols intended to meet regulatory requirements or specified in regulatory guidelines on labelling. We use cookies to make our website easier to use and to better understand your needs. Symbol development, selection and validation BS ISO specifies a process for developing, selecting and validating symbols for inclusion in ISO Many countries require that their own language be used to present textual information with medical devices.

Symbol development, selection and validation. Search all products by. Establishing need Providing guidance on development of symbols Carrying out testing to make sure that the candidate symbol is suitable for adoption and use.

It can also be used by manufacturers and regulators for validating symbols for use with medical devices, where they are not standardized. Take the smart route to manage medical device compliance.

Association for the Advancement of Medical Instrumentation

In addition, some users and 1523-2 authorities have concerns that the unrestricted use of symbols without validation can represent a hazard. Good clinical practice BS EN However, the proliferation of symbols without control and harmonization is undesirable and detracts from the effectiveness of using symbols to convey information for safety.

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