3. Normative framework

Sterilization and traceability of multi-use surgical instruments

Standard XP S94-467: 2006 specified the requirements for identifying each surgical instrument uniquely and univocally by a registration number. This registration number is one of the elements required to ensure the traceability of surgical instruments. This standard applied to surgical instruments used in healthcare establishments and private practices, from receipt to disposal.

The number consists of a manufacturer identifier, the product reference and a unique serial number. Surgical instruments whose configuration does not permit state-of-the-art identification support...