UNE-EN 556-2:2025
Current
The latest, up-to-date edition.
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
Hardcopy , PDF
Spanish, Castilian, English
18-06-2025
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.
| Committee |
CTN 111
|
| DocumentType |
Standard
|
| Pages |
20
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN 556-2:2024 | Identical |
Access your standards online with a subscription
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.
Important note : Users cannot be edited or removed once added to your Multi user PDF.