BAS EN 556-2:2007
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
General Information
Status: Withdrawn
No. of pages: 12
Language: English
Edition: 1.
Adoption method: Endorsment
Publication date: 03.07.2007
Technical committee:
Directive:
90/385/EEC, Active implantable medical devices
93/42/EEC, Medical devices;
98/79/EC, In vitro diagnostic medical devices;
93/42/EEC, Medical devices;
98/79/EC, In vitro diagnostic medical devices;
...
Abstract
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).
Lifecycle
...
Original document and degree of correspondence
- EN 556-2:2003, identical