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EVS-EN 556-2:2015

Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices

General information
Valid from 06.10.2015
Base Documents
EN 556-2:2015

Standard history

Status
Date
Type
Name
Main
prEN 556-2
06.10.2015
Main
04.06.2004
Main
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), 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.
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