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DIN EN ISO 18113-4

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)

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Organization: DIN
Publication Date: 1 January 2013
Status: active
Page Count: 20
ICS Code (In vitro diagnostic test systems): 11.100.10
scope:

This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents for self-testing.

This part of ISO 18113 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing.

This part of ISO 18113 can also be applied to accessories.

This part of ISO 18113 applies to the labels for outer and immediate containers and to the instructions for use.

This part of ISO 18113 does not apply to:

a) IVD instruments or equipment,

b) IVD reagents for professional use.

Document History

September 1, 2021
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO/DIS 18113-4:2021); German and English version prEN ISO 18113-4:2021
A description is not available for this item.
DIN EN ISO 18113-4
January 1, 2013
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents for self-testing. This part of ISO 18113 also applies to information supplied by the...
May 1, 2010
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)
A description is not available for this item.

References

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