Standard

SN EN ISO 3826-2:2008

Current

Existing or new amendments and versions must be purchased separately.

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Abstract

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 i

Products specifications

  • Standard from INB
  • Published:
  • Effective:
  • Document type: EN
  • Pages
  • ICS: 11.040.20
  • ICS: 01.080.20
  • Publisher: SNV
  • Distributor: SNV
  • National Committee: INB/NK 2205

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