Standard Swedish standard · SS-EN 556-2:2004

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

Status: Withdrawn · Replaced by: SS-EN 556-2:2015

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 only permissible when a validated sterilization process has been applied. Requirements for validation and routine control of aseptic processes are specified in prEN 13824 (in preparation).


Sterilization and disinfection in general (11.080.01)

Product information

Language: English

Written by: SIS - Hälso- och sjukvård

International title:

Article no: STD-37374

Edition: 1

Approved: 9/24/2004

No of pages: 10

Replaced by: SS-EN 556-2:2015