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labelling

written, printed or graphic matter

affixed to an IVD medical device or any of its containers or wrappers or

provided for use with an IVD medical device,

 related to identification and use, and giving a technical description, of the IVD medical device, but excluding shipping documents

Note 1

In IEC standards, documents provided with a medical device and containing important information for the responsible organization or operator, particularly regarding safety, are called “accompanying documents”.

Note 2

Catalogues and material safety data sheets are not considered labelling of IVD medical devices.

Note 3

Adapted from ISO 13485:2003, definition 3.6.

Norm
NEN-EN-ISO 18113-1:2011 en
Titel
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements
Paragraaf
3.29
Terug

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