BAS EN 556-1:2003
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
General Information
Status: Published
No. of pages: 8
Language: English
Edition: 1.
Adoption method: Endorsment
Publication date: 18.11.2003
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;
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Abstract
This European Standard 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 550, EN 552, EN 554, EN ISO 14160 and EN ISO 14937.
Lifecycle
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Original document and degree of correspondence
- EN 556-1:2001, identical