BS-EN-556-2 › Historical Revision Information
Sterilization of medical devices. Requirements for medical devices to be designated STERILE. Requirements for aseptically processed medical devices

BS-EN-556-2 - 2003 EDITION - SUPERSEDED
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Part 2 of BS EN 556 specifies the requirements for an aseptically processed medical device to be designated “STERILE”.

Designation of a medical device as “STERILE” is only permissible when a validated sterilization process has been applied.


Keywords

Sterile equipment;Contamination;Microorganisms;Sterilization (hygiene);Controlled-atmosphere rooms;Particulate materials;Medical instruments;Medical equipment;Environment (working);Quality control;Contaminants

To find similar documents by classification:

11.080.01 (Sterilization and disinfection in general Including sterilization methods, air quality of surgery rooms, etc.)

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Document Number

BS EN 556-2:2003

Revision Level

2003 EDITION

Status

Superseded

Publication Date

Jan. 31, 2004

Replaced By

BS EN 556-2:2015

Page Count

12

ISBN

0580432130

International Equivalent

EN 556-2:2003

Committee Number

CH/198