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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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.

Association for the Advancement of Medical Instrumentation

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: If the symbol validation process detailed in BS ISO has been complied with, then the residual risks iwo with the usability of a medical device symbol are presumed to be acceptable unless there is objective evidence to the contrary.

BS ISO is not restricted to symbols intended to meet regulatory requirements or specified in regulatory guidelines on labelling. Many countries require that their own language be used to present textual information with medical devices. This presents problems to device manufacturers and users.

ISO proposes solutions to these problems through the use of internationally recognized symbols, with precisely defined meanings, that are independent of language.


Some of the best practices for symbols development and usage have been translated into normative requirements in ISO Much of the information required on a medical device itself, as part of the lso, or provided with the device constitutes information for safety within an integrated approach to risk management. As with any risk control measure, the manufacturer needs to verify the effectiveness of the information isoo safety before it can be accepted.

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


This part of ISO includes methods for validating those candidate symbols being proposed for inclusion in ISO It can also be used by manufacturers and regulators for validating symbols for use with medical devices, where they are not standardized. When the processes detailed in this part of ISO have been carried out, the probability of misinterpretation of symbols accepted in ISO is reduced. Worldwide Standards We can source any standard from anywhere in the world.

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You may find similar items within these categories by selecting from the choices below:. 152223-2 to be used with medical device labels, labelling, and information to be supplied. Symbol development, selection and validation Status: Click to learn more. Symbol development, selection and validation The Isl series of standards addresses symbols that can be used to convey information that 15223-2 essential for the iwo and proper use of medical devices.


General requirements Part 2: Symbol development, selection and validation BS ISO specifies a process for developing, selecting and validating symbols for inclusion in ISO Establishing need Providing guidance on development of symbols Carrying out testing to make sure that the candidate symbol is suitable for adoption and use. Bei Aufschriften von Medizinprodukten zu verwendende Symbole, Kennzeichnung und zu liefernde Informationen. Your basket is empty. Take the smart route to manage medical device compliance.

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This website is best viewed with browser version of up to Microsoft Internet Explorer 1522-2 or Firefox 3. We use cookies to make our website easier to use and to better understand your needs. Accept and continue Learn more about the cookies we use and how to change your settings. Symbol development, selection and validation. Entwicklung von Symbolen, Auswahl und Bewertung.