EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of EN ISO 15223-2 testing. EN ISO 15223-2 specifies a process for developing, selecting and validating symbols for inclusion in EN ISO 15223-1. The purpose of EN ISO 15223-2 is to make the symbols in EN ISO 15223-1 easy to understand by the target group.
If the symbol verification process detailed in EN ISO 15223-2 is followed, residual risks as defined in ISO 14971 and IEC 62366 associated with the usability of the medical device symbol are assumed to be acceptable. objective evidence to the contrary.
EN ISO 15223-2 is not limited to symbols intended to meet regulatory requirements or specified in regulatory guidelines for labeling.
The EN ISO 15223 International series of standards deals with symbols that can be used to convey information necessary for the safe and correct use of medical devices. Therefore, in most regulatory areas, symbols must be presented with the device. Information may need to be provided on the device itself, as part of the label, or provided with the device.
Many countries require the use of their own language to present textual information with medical devices. This poses a problem for device manufacturers and users. Faced with the requirement to produce labels in several different languages, manufacturers may have to increase the size of the package or label, potentially increasing packaging waste or compressing information, compromising legibility. Presented with devices labeled in various languages, users may experience confusion and delay in finding required information in an appropriate language. EN ISO 15223-1 proposes solutions to these problems through the use of language-independent, internationally accepted symbols with strictly defined meanings.
EUROLAB assists manufacturers with EN ISO 15223-2 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.
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EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
