UNE-EN 556-1:2025
Current
The latest, up-to-date edition.
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
Hardcopy , PDF
Spanish, Castilian, English
22-01-2025
This document specifies the requirements for a terminally sterilized medical device to be designated STERILE . Part 2 of this European standard 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), designation of a medical device as STERILE is only permissible when a validated sterilization process has been applied. Requirements for validation and routine control of processes for the sterilization of medical devices are specified in EN ISO 11135, EN ISO 11137, EN ISO 14160, EN ISO 14937, EN ISO 17665-1, EN ISO 20857, EN ISO 25424 and ISO 22441.
| Committee |
CTN 111
|
| DocumentType |
Standard
|
| Pages |
17
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Current
|
| Standards | Relationship |
| EN 556-1:2024 | 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.