BS-EN-556-2 › Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE'

BS-EN-556-2 - 2015 EDITION - CURRENT
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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

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

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 556-2:2015

Revision Level

2015 EDITION

Status

Current

Publication Date

Sept. 30, 2015

Replaces

BS EN 556-2:2003

Replaced By

BS EN 556-2:2024

Page Count

20

ISBN

9780580809613

International Equivalent

EN 556-2:2015

Committee Number

CH/198