ISO 15223-1:2021 5.7b: Translation and repackaging: name the responsible entity and use the symbols only when another party acted

What does 5.7b require?

The translation symbol (5.7.8) and the repackaging symbol (5.7.9) are accompanied by the name and address of the entity that translated the information or repackaged the device, and each is used only when that activity was performed by someone other than the original manufacturer.

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