ISO 15223-2 PDF

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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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: Good clinical practice BS EN Symbol development, selection and validation BS ISO specifies a process for developing, selecting and validating symbols 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.

BS ISO 15223-2:2010

Bei Aufschriften von Medizinprodukten zu verwendende Symbole, Kennzeichnung und zu liefernde Informationen.

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. This presents problems to device manufacturers and users. This part of ISO includes methods for validating those candidate symbols being isoo for inclusion in ISO However, the proliferation of symbols without control and harmonization is undesirable and detracts from the effectiveness of using symbols to convey information for isp.

ISO proposes solutions to these problems through the use of internationally recognized symbols, with precisely defined meanings, that are independent of language. General requirements Part 2: 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.

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ANSI/AAMI/ISO /(R)

Accept and continue Learn more about the cookies we use and how to change your settings. As such, in most regulatory domains the symbols are required to be presented with the jso.

We use cookies to make our website easier to use and to better understand your needs. In addition, some users and regulatory authorities have concerns that the unrestricted use of symbols without validation can represent a hazard.

Please download Chrome or Firefox or view our browser tips. As with any risk control measure, the manufacturer needs to verify the effectiveness of the information for safety before it can be accepted. Click to learn more. Take the smart route to manage medical device compliance. You may experience issues viewing this site in Internet Explorer 9, 10 or Entwicklung von Symbolen, Auswahl und Bewertung. Worldwide Standards We can source any standard from anywhere in the world.

You may find similar items within these categories by selecting from the izo below:. Many countries require that their own language be used to present textual information with medical devices.

When the processes detailed in this part of ISO have been carried out, the probability of misinterpretation of symbols accepted in ISO is reduced. Find Similar Items This product falls into the following categories. Some of the best practices for symbols development and usage have been translated into normative requirements in ISO 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.

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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. 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.

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. This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3.

Symbols to be used with medical device labels, labelling, and information to be supplied. Your basket is empty. Symbol development, selection and validation Status: Search all products by. Establishing need Providing guidance on development of symbols Carrying out testing to make sure that the candidate symbol is suitable for adoption and use. BS ISO is not restricted to symbols intended to meet regulatory requirements or specified in regulatory guidelines on labelling.

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