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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Association for the Advancement of Medical Instrumentation

When the processes detailed in this part of ISO have been carried out, the probability of misinterpretation of symbols accepted in ISO is reduced. It can also be used by manufacturers and regulators for validating symbols for use with medical devices, where they are not standardized. However, the proliferation of symbols without control and harmonization is undesirable and detracts from the effectiveness of using symbols to convey information for safety. Entwicklung von Symbolen, Auswahl und Bewertung.

This presents problems to device manufacturers and users.


Worldwide Standards 15223-22 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. Click to learn more.

In addition, some users and regulatory authorities have concerns that the unrestricted use of symbols without validation can represent a hazard. 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 15232-2 acceptable unless there is objective evidence to the contrary.


Symbol development, selection and validation BS ISO specifies a process for developing, selecting and validating symbols for inclusion in ISO Symbol development, selection and validation Status: Symbol development, selection and validation.

This standard is in two parts 1522-32, under the general title Medical devices – Symbols to be isp with medical device labels, labelling and information to be supplied: We 115223-2 cookies to make our website easier to use and to better understand your needs. Some of the best practices for symbols development and iao have been translated into normative requirements in ISO BS ISO is not restricted to symbols intended to meet regulatory requirements or specified in regulatory guidelines on labelling.

Establishing need Providing guidance on development of isoo Carrying out testing to make sure that the candidate symbol is suitable for adoption and use. 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.

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. Take the smart route to manage medical device compliance. This website is best viewed with browser version lso up to Microsoft Internet Explorer 8 or Firefox 3. You may experience issues viewing this site in Internet Explorer 9, 10 or Symbols to be used with medical device labels, labelling, and information isso be supplied.


Accept and continue Learn more about the cookies we use and how to change your settings. General requirements Part 2: Please download Chrome or Firefox or view our browser tips. 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. Good clinical practice BS EN Many countries require that their own language be used to present textual information with medical devices.

This part of Isk includes methods for validating those candidate symbols being proposed for inclusion in ISO As with any risk control measure, the manufacturer needs to verify the effectiveness of the information for safety before it can be accepted. ISO proposes solutions to these problems through the use of internationally recognized symbols, with precisely defined meanings, that are independent of language. You may find similar items within these categories by selecting from the choices below:.

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As such, in most regulatory domains the symbols are required to be presented with the device. Bei Aufschriften von Medizinprodukten zu verwendende Symbole, Kennzeichnung und zu liefernde Informationen.

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