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DIN EN ISO 18113-4-2010
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing
适用范围：This part of DIN EN ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents for self-testing. Furthermore, this part of DIN EN ISO 18113 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 DIN EN ISO 18113 can also be applied to accessories, where appropriate. This part of DIN EN ISO 18113 applies to labels for the outer and immediate container and to the instructions for use.
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