21/30416041 DC

This standard 21/30416041 DC BS EN ISO 18113-4. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) is classified in these ICS categories:

• 11.100.10 In vitro diagnostic test systems

This document specifies requirements for information supplied by the manufacturer of IVD reagents, calibrators, and controls intended for self-testing.

This document can also be applied to accessories.

This document applies to the labels for outer and immediate containers and to the instructions for use.

This document does not apply to:

1. IVD instruments or equipment;

2. IVD reagents for professional use.