AAMI 15223-1 pdf free download

AAMI 15223-1 pdf free download.Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied — Part 1: General requirements.
3.2 description normative text attached to the representation of the symbol original, which defines the purpose, the application, and the use of the symbol original [IEC 8041 6-1 :2001 , definition 3.6] 3.3 iconic presentation pictorial or graphic representation using familiar objects including alphanumeric characters 3.4 label written, printed, or graphic information provided upon the medical device itself NOTE 1 Where physical constraints prevent this happening, this term includes information provided on the packaging of each unit or on the packaging of multiple devices. NOTE 2 Adapted from GHTF/SG1 /N043:2005. 3.5 labeling written, printed, or graphic matter ⎯ affixed to a medical device or any of its containers or wrappers or ⎯ accompanying a medical device, related to identification, technical description and use of the medical device, but excluding shipping documents NOTE Some regional and national regulations refer to “labeling” as “information supplied by the manufacturer.” [ISO 1 3485:2003, definition 3.6]3.6 symbol concept diagrammatic representation of a symbol that conveys the essential elements of the symbol but which is not yet formally translated into the format required for a symbol original 3.7 symbol original drawing of a symbol, prepared in accordance with IEC 8041 6-1 , used for reference or reproduction purposes NOTE Adapted from IEC 8041 6-1 :2001 , definition 3.3. 3.8 symbol used in medical device labeling an object presented on the label and/or associated documentation of a medical device that communicates characteristic information (see 3.1 ) without relying on knowledge of the language of a particular nation or people by the supplier or receiver of the information NOTE The symbol can utilize symbolic or iconic presentation.4 General requirements 4.1 Proposal for symbols for adoption Proposals for symbols for adoption into ISO 1 5223 shall be submitted to the secretariat of ISO/TC 21 0. Symbols being proposed shall be presented following the dimensional criteria and design principles set out in ISO/IEC 8041 6 series. Where the presentation is symbolic, alphanumeric characters shall not be part of the symbol. Alphanumeric characters may be used when appropriate and relevant in a symbol with iconic presentation. Symbols presented for advice on acceptability or procedural details, may be presented as symbol concept (see 3.6). Symbols presented for formal adoption shall be symbol originals (see 3.7). When a symbol is presented for advice or adoption, the details set out in Annex B shall be provided. Any symbol proposed for adoption into this part of ISO 1 5223 shall be applicable to a range of devices and have global applicability. Other standards specify additional symbols that are applicable to particular kinds or groups of devices or to particular situations. Examples of such sources are identified in the Bibliography. This listing is not exhaustive.4.2 Requirements for usage When risk management shows it to be appropriate for symbols to be used to convey information essential for proper use on the medical device, on its package or in associated documentation, the symbols given in Table 1 may be used. In use, the graphical representation of symbols shall comply with that shown in this part of ISO 1 5223, especially with respect to dimensions, including relative line thickness, orientation and the absence or presence of filled or shaded areas. NOTE 1 ISO and IEC jointly maintain an on-line database of Graphical Symbols for Use on Equipment, which contains the complete set of graphical symbols included in ISO 7000 [2] and IEC 6041 7 [8,9] . In that database, each graphical symbol is identified by a reference number and contains a title (in English and French), a graphical representation in GIF and vectorized PDF format, and some additional data as applicable. Various search and navigation facilities allow for easy retrieval of graphical symbols. Information on how to access this database is available through the ISO Store [1 2] , the IEC Web Store [1 3] , or by contacting your local National Standards Body. The symbols and associated information shall be legible when viewed under an illumination of 21 5 lx using normal vision, corrected if necessary. NOTE 2 Colors and minimum dimensions are not specified in this part of ISO 1 5223.AAMI 15223-1 pdf download.