BS ISO 20417:2021 Medical devices — Information to be supplied by the manufacturer

BS ISO 20417:2021 Medical devices — Information to be supplied by the manufacturer. 6.1.6 Safety signs a) For the purpose of this subclause, where a safety sign is used to convey a warning, prohibition or mandatory action that mitigates a risk that is not obvious to the user, it shall be a safety sign selected from ISO 7010. b) If a safety sign with an established meaning is appropriately used, the use of the general warning safety sign ISO 7010-WOOl is not required. NOTE In this context, warning is used to mean “There is certain danger prohibition is used to mean “You must not…: and mandatory action is used to mean “You must…. c) Where a safety sign is not available to indicate a particular desired meaning, the meaning may be obtained by one of the following methods. 1) Constructing a safety sign according to ISO 3864-1:2011, Clause7, 2) Using the general warning safety sign ISO 7010-WOOl placed together with a supplementary symbol or text. i) The text associated with the general warning safety sign shall be an affirmative statement (i.e., a safety notice) describing the principal risk(s) foreseen (e.g., “Causes burns”, “Risk of explosion”). 3) Using the general prohibition safety sign ISO 7010-POOl placed together with a supplementary symbol or text. i) The text associated with the general prohibition safety sign shall be a statement (i.e., a safety notice) describing what is prohibited (e.g., “Do not open”, “Do not drop”). 4) Using the general mandatory action safety sign ISO 7010-MOOl placed together with a supplementary symbol or text. i) The text associated with the general mandatory action safety sign shall be a command (i.e., a safety notice) describing required action (e.g., “Wear protective gloves”, Scrub before entering”). d) If there is insufficient space to place the affirmative statement together with the safety sign on the medical device or accessory, the affirmative statement may be placed in the instructions for use. NOTE The colours for safety signs specified in ISO 7010 are specified in ISO 3864-1 and It is important to use the specified colour. e) Additionally, a safety notice should include the appropriate precautions or include instructions on how to reduce the risk (e.g., “Do not use for. . . “, “Keep away from…”). 1) Safety signs, including any supplementary symbol or text: 1) shall be explained in the instructions for use; and 2) if colour is not utilized...