Superseded Standard
Historical

DIN EN ISO 18113-5:2013-01

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009); German version EN ISO 18113-5:2011.

Summary

This part of DIN EN ISO 18113 specifies requirements for information supplied by the manufacturer of IVD instruments for self-testing. Furthermore, this part of DIN EN ISO 18113 also applies to apparatus, equipment, calibrator and control materials intended to be used with IVD instruments for self-testing. This part of DIN EN ISO 18113 can also be applied to accessories, where appropriate.

Notes

DIN EN ISO 18113-5 (2010-05) remains valid alongside this standard until 2014-10-31.

Technical characteristics

Publisher Deutsche Institut für Normung e.V. (DIN)
Publication Date 01/01/2013
Page Count 17
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