ISO 15223-1:2021 5.6: Transfusion and infusion devices: replace example values with the device's own

What does 5.6 require?

Transfusion and infusion devices use the sampling site, fluid path, non-pyrogenic and one-way valve symbols (5.6.1 to 5.6.3, 5.6.6) as applicable; in the drops per millilitre symbol (5.6.4) the example figure is replaced by the device's actual drop rate, and in the liquid filter symbol (5.6.5) the example pore size is replaced by the filter's nominal pore size.

Maintained by Gerard Blokdyk

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

5.1a Manufacturer and authorised representative: place the name and address beside the symbol
5.1b Date of manufacture and use-by date: place the date beside the symbol in ISO 8601 form
5.1c Batch code, catalogue number, serial number and model number: place the value beside the symbol
5.1d Importer and distributor: place the name and address beside the symbol
5.1e Country of manufacture: replace the placeholder with the ISO 3166-1 code
5.2a Sterility: use the symbol for the actual sterilisation method and identify what is sterile
5.2b Sterile barrier system symbols: place them with the sterility symbol
5.3 Storage conditions: write the limit values beside the limit lines

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.

MCP endpoint All ISO 15223-1:2021 controls