TS EN ISO 3826-2
Plastics collapsible containers for human blood and blood components - Part 2: Graphical symbols for use on labels and instruction leaflets
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. The use of these symbols is primarily intended for the medical device rather than the therapeutic product.
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About This Item
TS EN ISO 3826-2 addresses graphical symbols for labels and instruction leaflets used with plastic collapsible containers for human blood and blood components. It focuses on symbols that can carry information for blood collection and storage devices, helping standardise meanings where text alone can be difficult to manage across multiple languages.
From a general technical perspective, standardised symbols make medical-device information easier to recognise quickly and more consistently in international supply chains. In blood services, manufacturing, distribution and handling environments, the distinction between information shown on the device itself, on the label, or in a separate leaflet matters because each channel serves a different practical purpose. This part of ISO 3826 does not replace national language or regulatory requirements; it supports clearer labelling by giving internationally recognised symbols defined meanings.
Why symbol standardisation matters for blood bag labelling
Plastic blood bags are not just containers; they are part of a medical workflow where correct identification and traceable information are essential. A shared symbol system helps reduce translation complexity, layout conflicts and the risk of inconsistent product presentation when the same device is marketed in different countries. In that sense, the standard supports communication efficiency for manufacturers and for organisations working along the blood supply chain.
- Covers graphical symbols for labels and instruction leaflets.
- Applies to medical devices dedicated to blood collection, processing, storage and distribution.
- Supports internationally recognised meanings for device information.
- Does not override national language or regulatory labelling obligations.
- Primarily intended for the device and the information supplied with it.
- Publication Date: 9.04.2009
- Standard Status: U (Yürürlükteki Standard/Standard)
- Publisher: TSE
- Document Language: en
- ICS Classification: 01.080.20 Özel Ekipmanlarda Kullanılan Grafik Semboller ; 11.040.20 Transfüzyon, Infüzyon ve Enjeksiyon Ekipmanları *Kan torbaları dahil
- Pages: 24
- Source Standard: EN ISO 3826-2:2008
- International Equivalents: ISO 3826-2-EQV; EN ISO 3826-2-EQV
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