July 6th, 2021, the 4th edition of the ISO 15223-1:2021 Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements was published. This new addition includes 20 newly validated symbols and 5 symbols previously published in ISO 7000, ISO 7001 and IEC 60417 as well as including defined terms from ISO 20417, ISO 13485 and ISO 14971.
The newly added symbols in the 4th edition include symbols for:
- Importer
- Distributor
- Model number
- Country of manufacture
- Sterilized using vaporized hydrogen peroxide
- Single sterile barrier system
- Double sterile barrier system
- Single sterile barrier system with protective packaging inside
- Single sterile barrier system with protective packaging outside
- Contains human blood or plasma derivatives
- Contains a medicinal substance
- Contains biological material of animal origin
- Contains biological material of human origin
- Contains hazardous substances
- Contains nano materials
- Single patient multiple use
- Patient name
- Patient identification
- Patient information website
- Health care centre or doctor
- Date
- Medical Device
- Translation
- Repackaging
- Unique Device Identifier
These symbols provide a means of conforming to the information to be provided on medical devices in the General Safety and Performance Requirements (GSPRs) of the Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostics Regulation (IVDR 2017/746) and address information required for patient implant cards and unique device identification.
What does this mean to you?
This new edition provides new symbols that will allow you to more easily conform with specific GSPR requirements and will ensure consistency and uniformity across the industry. The ISO organisation does not foresee a transitional period, the standards takes immediate effect.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.
