ISO 15223-1:2021 — Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements

Identifies internationally recognized symbols for use in labelling of medical devices. Includes symbols for manufacturer information, date of manufacture, use-by date, batch code, catalogue number, serial number, sterilization method, single use, temperature limits, humidity limits, and many other regulatory and safety-related label elements. Widely referenced by EU MDR, FDA, and other regulatory frameworks.

Standard Details

• Standard Number: ISO 15223-1:2021
• Type: ISO Standard
• Published by: ISO
• Official Link: https://www.iso.org/standard/77326.html

This standard is referenced in the harmonized standards lists for the EU Medical Device Regulation (MDR) 2017/745, EU In Vitro Diagnostic Regulation (IVDR) 2017/746, and is recognized by regulatory authorities worldwide including the FDA, Health Canada, and TGA.