標準號：BS EN ISO 3826-2-2008
中文標準名稱：人類血液及血液成分用塑料可折疊容器.用于標簽和說明手冊上的圖形符號
英文標準名稱：Plastics collapsible containers for human blood and blood components - Part 2: Graphical symbols for use on labels and instruction leaflets
標準類型：C47
發(fā)布日期：2008/12/31 12:00:00
實施日期：2008/12/31 12:00:00
中國標準分類號：C47
國際標準分類號：01.080.20;11.040.20
引用標準：ISO 15223-1
適用范圍：This part of ISO 3826 addresses symbols that may be used to convey certain items of information related tomedical devices dedicated to blood collection processes and storage. The information may be required on thedevice itself, as part of the label, or provided with the device. Many countries require that their own languagebe used to display textual information with medical devices. This raises problems to device manufacturers andusers.The symbols specified in this part of ISO 3826 do not replace current national regulatory requirements.Manufacturers seek to take costs out of labelling by reducing or rationalizing variants. This results in a majorproblem of translation, design and logistics when multiple languages are included on a single label or piece ofdocumentation. As other medical devices, blood medical devices, labelled in a number of different languages,can experience confusion and delay in locating the appropriate language. This part of ISO 3826 proposessolutions to these problems through the use of internationally recognized symbols with precisely definedmeanings.This part of ISO 3826 is primarily intended to be used by manufacturers of medical devices dedicated to theblood collection, process storage and distribution, who market identical products in countries having differentlanguage requirements for medical device labelling.This part of ISO 3826 may also be of assistance to different stages of the blood supply chain, e.g.:- distributors of blood collection devices (manual or automated) or other representatives of manufacturers;- blood centres and distribution centres to simplify and secure the operating procedures.The use of these symbols is primarily intended for the medical device rather than the therapeutic product.This part of ISO 3826 does not specify requirements relating to the size and colour of symbols although thesymbols specified have been specially designed so as to be clearly legible when reproduced in the spacetypically available on the labels of blood treatment and transfusion devices, and also so as to be suitable foron-line printing.Several of the symbols specified in this part of ISO 3826 may be suitable for application in other areas ofmedical technology.