In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) - In vitro diagnostic reagents for self-testing Ingestion-build-181247 1 This document specifies the

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In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) - In vitro diagnostic reagents for self-testing Ingestion-build-181247 1 This document specifies the1 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