BS-EN-556-1 › Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE'

BS-EN-556-1 - 2024 EDITION - CURRENT
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BS EN 556-1 is the standard that specifies the requirements for a terminally sterilized medical device to be designated “STERILE”.

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

Marking;Sterile equipment;Medical instruments;Quality assurance;Quality control;Sterilization (hygiene);Medical equipment;Microorganisms

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 556-1:2024

Revision Level

2024 EDITION

Status

Current

Publication Date

July 3, 2024

Replaces

BS EN 556-1:2001

Page Count

20

ISBN

9780539226812

International Equivalent

EN 556-1

Committee Number

CH/198