risk control measure

action taken to reduce or maintain risks within specified levels

Note 1

Risk control measures based on labelling are called information for safety in ISO 14971 and are considered the least effective risk control option in order of risk management priority. Labelling intended as information for safety includes—

instructions for use (see 3.30),

—

limitations of the procedure (see 3.35),

—

precautions (see 3.53),

—

warnings (see 3.74).

Note 2

General guidance on providing information for safety is provided in Annex J of ISO 14971:2007. General guidance for evaluating information for safety as a risk control measure, including review of warnings and review of the operating instructions, is provided in D.7 of ISO 14971:2007.

Note 3

Specific guidance pertaining to information for safety of IVD medical devices is provided in Annex H of ISO 14971:2007.

Note 4

Derived from ISO 14971:2007, definition 2.19.

Norm

NEN-EN-ISO 18113-1:2011 en

Titel

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements

Paragraaf

3.62

risk control measure

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