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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Symbols to be used with medical device labels, labelling, and information to be supplied. Please download Chrome or Firefox or view our browser tips. Many countries require that their own language be used to present textual information with medical devices.
Search all products by. The ISO series of standards addresses symbols io can be used to convey information that is essential for the oso and proper use of medical devices. As with any risk control measure, the manufacturer needs lso verify the effectiveness of the information for safety before it can be accepted.
Symbol development, selection and validation BS ISO specifies a process for developing, selecting and validating symbols for inclusion in ISO You may find similar items within these categories by selecting from the choices below:. 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.
As such, in most regulatory domains the symbols are required to be presented with the device.
Entwicklung von Symbolen, Auswahl und Bewertung. The information can be required to be presented on the device itself, as part of the label or provided with the device.
This part isso ISO includes methods for validating those candidate symbols being proposed for inclusion in ISO 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.
ISO proposes solutions to these problems through the use of internationally recognized symbols, with precisely defined meanings, that are independent of language. BS ISO is not restricted to symbols intended to meet regulatory requirements or specified in regulatory guidelines on 15223.
General requirements Part 2: You may experience issues viewing this site in Ido Explorer 9, 10 or Bei Aufschriften von Medizinprodukten zu verwendende Symbole, Kennzeichnung und zu 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.
Learn more about the cookies we use and how to change your settings. This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. 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
In addition, some users and regulatory authorities have concerns that the unrestricted use of symbols without validation can represent a hazard. This presents problems to device manufacturers and users.
Your basket is empty. Accept and continue Learn more about the cookies we use and how to change your settings. Symbol development, selection and validation Status: Symbol development, selection and validation. Establishing need Providing guidance on development of symbols Carrying out testing to make sure that the candidate symbol is suitable for adoption and use.