DIN EN ISO 3826-2:2008
人类血液及血液成分用塑料可折叠容器.第2部分:用于标签和说明手册上的图形符号

Plastics collapsible containers for human blood and blood components - Part 2: Graphical symbols for use on labels and instruction leaflets (ISO 3826-2:2008); English version of DIN EN ISO 3826-2:2008-11

被代替

标准号

DIN EN ISO 3826-2:2008

发布

2008年

发布单位

德国标准化学会

替代标准

DIN EN ISO 3826-2:2008-11

当前最新

DIN EN ISO 3826-2:2008-11

 

 

引用标准

ISO 15223-1

被代替标准

DIN EN ISO 3826-2:2007

适用范围

This part of ISO 3826 addresses symbols that may be used to convey certain items of information related to medical devices dedicated to blood collection processes and storage. The information may be required on the device itself, as part of the label, or provided with the device. Many countries require that their own language be used to display textual information with medical devices. This raises problems to device manufacturers and users. 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 major problem of translation, design and logistics when multiple languages are included on a single label or piece of documentation. 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 proposes solutions to these problems through the use of internationally recognized symbols with precisely defined meanings. This part of ISO 3826 is primarily intended to be used by manufacturers of medical devices dedicated to the blood collection, process storage and distribution, who market identical products in countries having different language 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 the symbols specified have been specially designed so as to be clearly legible when reproduced in the space typically available on the labels of blood treatment and transfusion devices, and also so as to be suitable for on-line printing. Several of the symbols specified in this part of ISO 3826 may be suitable for application in other areas of medical technology.

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