ISO 15223-1:2021
Clause 5 and Table 1: Symbols and their requirements of use – ISO 15223-1:2021

ISO 15223-1:2021 5.5: IVD devices: use the IVD symbols and state the number of tests and the evaluation restriction

What does 5.5 require?

In vitro diagnostic devices carry the IVD symbol (5.5.1) and, for controls, the control, negative control and positive control symbols (5.5.2 to 5.5.4); the symbol for the number of tests (5.5.5) has the actual number of tests the device can perform written next to it; and a device intended only for performance evaluation carries the symbol in 5.5.6, which is distinct from the investigational use wording that may apply elsewhere.

Maintained by Gerard Blokdyk

Other controls in Clause 5 and Table 1: Symbols and their requirements of use – ISO 15223-1:2021

Query this from an agent

The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.