Information for safety

Under ISO 14971, information for safety is the last option in the risk control order and cannot replace a safer design that is feasible. Each safety statement in the labeling should trace back to the risk it controls.

information provided to the user or responsible organization as a risk control measure EXAMPLE 1 Warnings, precautions or contraindications. EXAMPLE 2 Instructions for the use of a medical device or accessory to prevent use error or avoid a hazardous situation. EXAMPLE 3 Explanation of a safety feature of a medical device. Note 1 to entry: Information for safety may be found in any or all types of information supplied by the manufacturer. Note 2 to entry: Information for safety can be located on the display of a medical device.

ISO 20417:2021, clause 3.9