ISO 15223-1:2016 pdf free
ISO 15223-1:2016 pdf free.Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied
Symbols proposed for adoption in this document shall be validated in accordance with ISO 15223-2.Any symbol proposed for adoption in this document shall be applicable to a range of medical devices and have global or regional applicability.
When risk management shows it to be appropriate for symbols to be used to convey information essential for proper use on the medical device, its packaging or in associated documentation, the symbols given in Table 1 may be used.
Symbols that are registered in ISO 7000 shall comply with the graphical representation in ISO 7000,especially with respect to relative dimensions, including relative line thickness, orientation and the absence or presence of filled or shaded areas.
NOTE 1 ISO and IEC jointly maintain an online database of graphical symbols for use on equipment, which contains the complete set of graphical symbols included in ISo 7000 and IEC 60417 available at https://www.iso.org/obp/ui/#search. This online collection shows each graphical symbol and identifies it by a reference number and a title (in English and French). The graphical symbols are available in different formats (e.g. AI, DWG,EPS) and some additional data as applicable is provided. Various search and navigation facilities allow for easy retrieval of graphical symbols.
As part of risk management, the manufacturer should determine the appropriate size for the symbol to be legible for its intended function.
NOTE 2 This document does not specify colours or minimum size for the symbols in Table 1 nor does it specify the relative size of symbols and that of indicated information.It is important that symbols be used properly. Guidance on appropriate use of the general prohibition symbol and the negation symbol is given in Annex B.
Before symbols are used, the manufacturer shall carry out a risk assessment that indicates that the use of the symbol does not introduce an unacceptable risk.
NOTE 3 Additional information regarding risk assessment can be found in ISO 14971.Symbols may be used without accompanying text. Where regulations require accompanying text, the title of the symbol given in this document should be considered sufficient. All dates and times presented in association with symbols shall use the conventions set out in ISO 8601.ISO 15223-1 pdf free.
