ISO 3826-2:2008 人体血液和血液成分用可折叠塑料容器 第2部分：标签和指示单上使用的图形符号
标准编号：ISO 3826-2:2008
中文名称：人体血液和血液成分用可折叠塑料容器 第2部分：标签和指示单上使用的图形符号
英文名称：Plastics collapsible containers for human blood and blood components — Part 2: Graphical symbols for use on labels and instruction leaflets
发布日期：2008-08
标准范围
ISO 3826-2:20 08规定了可用于传达与专用于血液采集过程和储存的医疗设备相关的某些信息项的符号。该信息可能需要在设备本身上、作为标签的一部分或与设备一起提供。许多国家要求使用他们自己的语言来显示医疗设备的文本信息。这给设备制造商和用户带来了问题。ISO 3826-2:20 08中规定的符号不能替代现行国家法规要求。制造商试图通过减少或合理化变体来降低标签成本。当多种语言包含在单个标签或文档中时，这会导致翻译、设计和物流的主要问题。与其他医疗设备一样，以多种不同语言标记的血液医疗设备在定位适当语言时可能会经历混乱和延迟。ISO 3826-2:20 08通过使用具有精确定义含义的国际公认符号提出了这些问题的解决方案。ISO 3826-2:20 08主要供专门用于血液采集、加工储存和配送的医疗器械制造商使用，这些制造商在对医疗器械标签有不同语言要求的国家销售相同的产品。ISO 3826-2:20 08也可能有助于血液供应链的不同阶段，例如:采血设备（手动或自动）的经销商或制造商的其他代表；血液中心和分配中心简化和确保操作程序。这些符号的使用主要用于医疗器械，而不是治疗产品。
ISO 3826-2:2008 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 ISO 3826-2:2008 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. ISO 3826-2:2008 proposes solutions to these problems through the use of internationally recognized symbols with precisely defined meanings.ISO 3826-2:2008 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.ISO 3826-2:2008 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.
标准预览图
