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UNE EN 556-2:2025
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
Esterilización de productos sanitarios. Requisitos de los productos sanitarios para ser designados "ESTÉRIL". Parte 2: Requisitos de los productos sanitarios procesados asépticamente.
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| Standard number: | UNE EN 556-2:2025 |
| Pages: | 20 |
| Released: | 2025-06-18 |
| Status: | Standard |
DESCRIPTION
UNE EN 556-2:2025
This document specifies the requirements for an aseptically processed medical device to be designated 'STERILE'. NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designating that a medical device is 'STERILE' is permissible when a validated manufacturing and sterilization process has been applied. Requirements for validation and routine control of aseptic processes are specified in EN ISO 13408-1. Specific requirements for the aseptic processing of solid medical devices and combination products are specified in ISO 13408-7.