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


Document Center Inc. is an authorized dealer of BSI standards.
The following bibliographic material is provided to assist you with your purchasing decision:

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.)

This document comes with our free Notification Service, good for the life of the document.

This document is available in Paper format.

ORDER

Price:

$137.80




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