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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Click to learn more. You may find similar items within these categories by selecting from the choices below:. BS ISO is not restricted to symbols intended to meet regulatory requirements or specified in regulatory guidelines on labelling. 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.
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. Establishing need Providing guidance on development of symbols Carrying out testing to make sure that the candidate symbol is suitable for 1522-32 and use.
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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. As with any risk control measure, the manufacturer needs to verify the effectiveness of the information for safety before it can be accepted. Find Similar Items This product falls into the following categories.
When the processes detailed in this part of ISO have been carried out, the probability of misinterpretation of symbols accepted in ISO is reduced. Symbol development, selection and validation.
The information can be required to be presented on the device itself, as part of the label or provided with the device. Search all products by. Worldwide Standards We can source any standard from anywhere in the world. 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: 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.
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.
ios This part of ISO includes methods for validating those candidate symbols being proposed for inclusion in ISO Your basket is empty. It can also be used by manufacturers and regulators for validating symbols for use with medical devices, where they are not standardized. Accept and continue Learn more about the cookies we use and how to change your settings.
This presents problems to device manufacturers and users. Take the smart route to manage medical device compliance. Please download Chrome or Firefox or view our browser tips. General requirements Part 2: Good clinical practice BS EN Symbol development, selection and validation The ISO series of standards addresses symbols that can be used to convey information that ido essential for the safe and proper use of medical devices.
Symbol development, selection and validation Status: This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. Learn more about the cookies we use and how to change your settings.
Bei Aufschriften von Medizinprodukten zu verwendende Symbole, Kennzeichnung und zu liefernde Informationen. Many countries require that their own is be used to present textual information with medical devices. Symbols to be used with medical device labels, labelling, and information to iao supplied. However, the proliferation of symbols without control and harmonization is undesirable and detracts from the effectiveness of using symbols to convey information for safety.
BS ISO 15223-2:2010
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 Symbol development, selection and validation BS ISO specifies a process for developing, selecting and validating symbols for inclusion in ISO As such, in most regulatory domains the symbols are required to be presented with the device.