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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Establishing need Providing guidance on development of symbols Carrying out testing to make sure that the candidate symbol is suitable for adoption and use.
Find Similar Items This product falls into the following categories. 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. 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 isk integrated approach iao risk management. 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.
Association for the Advancement of Medical Instrumentation
This jso is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. This part of ISO includes methods for validating those candidate symbols being proposed for inclusion in ISO Symbol development, selection and sio Status: Learn more about the cookies we use and how to change your settings. Izo proposes solutions to these problems through the use of internationally recognized symbols, with precisely defined meanings, that are independent of language.
Search all products by. As such, in most regulatory domains the symbols are required to be presented with the device. 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.
In addition, some users and regulatory authorities have concerns that the unrestricted use of symbols without validation can represent a hazard. Sio countries require that their own language be used to present textual information with medical devices. This standard is isso two partsunder the general title Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied: Take the smart route to manage medical device compliance.
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BS ISO 15223-2:2010
Worldwide Standards We can source any standard from anywhere in the world. It can also be used by manufacturers and regulators for validating symbols for use with medical devices, where they are not standardized. Symbol development, selection and validation BS ISO specifies a process for developing, selecting and validating symbols for inclusion in ISO When the processes detailed in this part of ISO have been carried out, the probability of misinterpretation of symbols accepted in Is is reduced.
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.
You may find similar items within these categories by selecting from the choices below:. Bei Aufschriften von Medizinprodukten zu verwendende Symbole, Kennzeichnung und 152233-2 liefernde Informationen.
However, the proliferation of symbols without control and harmonization is undesirable and detracts from the effectiveness of using symbols to convey information for safety. Some of the best practices for symbols development and usage have been translated into normative requirements in ISO This presents problems to device manufacturers and users. As with any risk control measure, the manufacturer needs to verify the effectiveness of the information for safety before it can be accepted.
BS ISO is not restricted to symbols intended to meet regulatory requirements ieo specified in regulatory guidelines on labelling.
Symbol development, selection and validation. Please download Chrome or Firefox or view our browser tips.
You may experience issues viewing this site in Internet Explorer 9, 10 or The information can be required to be presented on the device itself, as part of the label or provided with the device.