Label, Labelling vs Instructions for Use (IFU)? What are the minimum requirements for labeling? The ISO has published many standards applicable to the medical device industry. Some of them are as below: Standard Number Standard Name ISO 18113 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 1, 2, 3, 4 and 5 ISO 28219 Packaging – Labelling and direct product marking with linear bar code and two-dimensional symbols ISO 15223 ...