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

ISO 15223-1:2021 5.2a: Sterility: use the symbol for the actual sterilisation method and identify what is sterile

What does 5.2a require?

A device supplied sterile is marked with the sterility symbol that matches how it was sterilised (aseptic processing, ethylene oxide, irradiation, steam or dry heat, vaporised hydrogen peroxide: clauses 5.2.2 through 5.2.5 plus 5.2.10), or with the general sterile symbol (5.2.1); non-sterile devices and devices not to be resterilised carry the matching symbols (5.2.6, 5.2.7), and a damaged-package warning (5.2.8) is used where the sterile barrier must be checked. Where only a fluid path is sterile (5.2.9), the sterilisation method is written in the empty part of that symbol as appropriate, and the manufacturer identifies in the supplied information which part of the device is sterile.

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.