ISO/TR 18112:2006
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users
15-02-2019
English
13-01-2006
ISO/TR 18112:2006 summarizes regulatory requirements and associated guidance for information supplied by the manufacturer with IVD medical devices intended for professional use.
Information supplied by the manufacturer includes labels on the outer and immediate container as well as instructions for use.
Current labelling regulations and regulatory guidance from Canada, the European Union, Japan and the United States are included.
Labelling guidance from the Global Harmonization Task Force and proposed labelling regulations from Australia are included for comparison.
IVD medical devices for self-testing are excluded.
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