EN-980 pdf free download

EN-980 pdf free download. Graphical symbols for use in the labelling of medical devices.
3 General requirements Graphical symbols used to convey the information given in 4.2 to 4.11 and 5.2 to 5.9 are given in this standard. NOTE 1 Other symbols can be used to convey other information. Where graphical symbols are not taken from a Harmonized Standard, their meaning should be described in the documentation supplied with the device. Many other standards specity symbols for particular purposes and/or for particular kinds of device. The Bibliography lists some of these standards. Enclosures shown in 4.2, 4.4, 4.7, 4.8.1, 4.8.2, 4.8.3, 4.10, 4.11, 5.3, 5.4, 5.6 and 5.8 shall be included as part of these symbols. NOTE 2 The use of similar enclosures around other symbols is not precluded (e.g. 4.5 and 4.9). All symbols and accompanying information shall be legible when viewed under an ilumination of 215 Ix using normal vision, corrected if necessary, at a distance which takes into account the specifics and size of the individual medical device. NOTE 3 Colours and minimum dimensions are not specified in this standard. 4 Symbols already in use 4.1 General This clause presents symbols that are well-understood and already in use and are recognised to be suitable without need for further explanation. This symbol shall be accompanied by the manufacturer’s batch code. The batch code shall be adjacent to the symbol. NOTE 1 Synonyms for “batch code” are “Iot number”, “batch number”. NOTE 2 The relative size of the symbol and the batch code is not specified. NOTE 3 The symbol No. 3.14 in ISO 15223 corresponds to this symbol. NOTE 4 See the Council Directive 90/385/EEC relating to active implantable medical devices, Annex I, 11, Council Directive 93/42/EEC concerning medical devices, Annex I, 13.3 (d) and Council Directive 98/79/EC on in vitro diagnostic medical devices, Annex I, B.8.4. (d). For active implantable medical devices, the symbol shall be adjacent to the date expressed as four digits for the year and two digits for the month. For active devices the symbol shall be accompanied by the year. The year shall be expressed as four digits in accordance with 5.2.1.2 a) of EN 28601:1992. NOTE 1 The relative size of the symbol and the date is not specified. NOTE 2 The symbol No. 3.13 in ISO 15223 corresponds to this symbol. NOTE 3 See Council Directive 90/385/EEC relating to active implantable medical devices, Annex 1, 14.1. and Council Directive 93/42/EEC concerning medical devices, Annex I, 13.3.(). 4.7 Symbol for “STERILE” This symbol is for terminlly-sterilized medical devices only. Subclause 4.1 (including its associated Note) of EN 556-1:2001 applies. NOTE1 The symbol No. 3.20 in ISO 15223 corresponds to this symbol. NOTE 2 See the Council Directive 90/385/EEC relating to active implantable medical devices, Annex I, 14.1, Council Directive 93/42/EEC concerning medical devices, Annex I, 13.3 (c) and Council Directive 98/79/EC on in vitro diagnostic medical devices, Annex I, B.8.4. (C). 4.8 Symbols for “STERILE”, including the “METHOD OF STERILIZATION” These symbols are for terminlly-sterilied medical devices only. Subclause 4.1 (including its associated Note) of EN 556-1 :2001 applies. NOTE 1 If any of the symbols given in 4.8.1 to 4.8.3 are used, it is not necessary in addition to use the symbol for sterile as shown in 4.7. NOTE 2 See the Council Directive 90/385/EEC relating to active implantable medical devices, Annex I, 14.1, Council Directive 93/42/EEC concerning medical devices, Annex I, 13.3 (C), (m) and the Council Directive 98/79/EC on in vitro diagnostic medical devices, Annex I, B.8.4. (C).EN-980  pdf download.