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

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

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.)

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

This document is available in either Paper or PDF format.

 

Customers who bought this document also bought:

ASTM-D4169
Standard Practice for Performance Testing of Shipping Containers and Systems

ASTM-F88
Standard Test Method for Seal Strength of Flexible Barrier Materials

BS-EN-980
Symbols for use in the labelling of medical devices

ORDER

Price:

$143.00        


Want this as a site license?



Document Number

BS EN 556-1:2001

Revision Level

2001 EDITION

Status

Current

Publication Date

Nov. 30, 2006

Replaces

BS EN 556:1995

Page Count

12

ISBN

0580383113

International Equivalent

EN 556-1:2001/AC:2006

Committee Number

CH/198