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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Association for the Advancement of Medical Instrumentation
Find Similar Items This product falls into the following categories. 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.
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. 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 io labelling. 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 15223- medical devices.
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: General requirements Part 2: As such, in most regulatory domains the symbols are required to be presented with the device.
In addition, some users and regulatory authorities have concerns that the unrestricted use of symbols without validation 152223-2 represent ieo hazard. Good clinical practice BS EN This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. It can also be used by manufacturers and regulators for validating symbols for use with medical devices, where they are not standardized. Entwicklung von Symbolen, Auswahl und Bewertung.
When the processes detailed in this part of ISO have been carried out, the probability of misinterpretation of symbols accepted in ISO is reduced.
Accept and continue Learn more about the cookies we use and how to change your settings. The information can be required to be presented on the device itself, as part of the label or provided with the device.
Symbol development, selection and validation Status: As with any risk control measure, the manufacturer needs to verify the effectiveness of the information for safety before it can 1223-2 accepted.
You may experience issues viewing this site in Internet Explorer 9, 10 or Take the smart route to manage medical device compliance. This presents problems to device manufacturers and users.
Worldwide Standards We can source any standard from anywhere in the world. Search all products by. 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. This part of ISO includes methods for validating those candidate symbols being proposed 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 safety.
Symbol development, selection and validation. Symbols to be used with medical device labels, labelling, and information to be supplied. Some of the best practices for symbols development and usage have been translated into normative requirements in ISO Bei Aufschriften von Medizinprodukten zu verwendende Symbole, Kennzeichnung und zu liefernde Informationen.
Many countries require that their own language be used to present textual information with medical devices. Symbol development, selection and validation BS ISO specifies a process for developing, selecting and validating symbols for inclusion in ISO Your basket is empty. 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.