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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Please download Chrome or Firefox or 12523-2 our browser tips. If the symbol validation process detailed in BS ISO has been complied with, then the residual risks oso with the usability of a medical device symbol are presumed to be acceptable unless there is objective evidence to the contrary.
When the processes detailed in ixo part of ISO have been carried out, the probability of misinterpretation of symbols accepted in ISO is reduced. As such, in most regulatory domains the symbols are required to be presented with the device. Entwicklung von Symbolen, Auswahl und Bewertung. 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: The information can be required to be presented on the device itself, as part of the label or provided with the device.
BS ISO is not restricted to symbols intended to meet regulatory requirements or specified in regulatory guidelines on labelling.
Association for the Advancement of Medical Instrumentation
Find Similar Items This product falls into the following categories. This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. You may experience issues viewing this site in Internet Explorer 9, 10 or 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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In addition, some users and regulatory authorities have concerns that the unrestricted use of symbols without validation can represent a hazard.
Many countries require that their own language be used to present textual information with medical devices. Establishing need Providing guidance on development of symbols Carrying out testing to make sure that the candidate symbol is suitable for adoption and use. Symbol development, selection and validation Status: This part of ISO includes methods for validating those candidate symbols being proposed for inclusion in ISO 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.
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.
It can also be used by manufacturers and regulators for validating symbols for use with medical devices, where they are not standardized. Your basket is empty. Worldwide Standards We can source any standard from anywhere in the world.
Click to learn more. 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. Some of the best isoo for symbols development and usage have been translated into normative requirements in ISO Take the smart route to manage medical device compliance.
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.
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. This presents problems to device manufacturers and users. Search all products by. Symbol development, selection and validation BS ISO specifies a process for developing, selecting and validating symbols for inclusion in ISO