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

BS-EN-556-1 - 2001 EDITION - CURRENT


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Included in this current edition are the following subparts:

 2001 EDITION - Dec. 11, 2001
 AMD 16728 - Oct. 31, 2006

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

Medical equipment, Medical instruments, Sterile equipment, Sterilization (hygiene), Quality assurance, Quality control, Marking, 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 556-1:2001

Revision Level

2001 EDITION

Status

Current

Publication Date

Dec. 11, 2001

Replaces

BS EN 556:1995

Page Count

12

ISBN

0580383113

International Equivalent

EN 556-1:2001

Committee Number

CH/198