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BS EN 556-2:2015

Sterilization of medical devices. Requirements for medical devices to be designated "STERILE"-Requirements for aseptically processed medical devices

standard by British-Adopted European Standard , 09/30/2015

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Full Description

BS EN 556-2:2015 specifies the requirements for an aseptically processed medical device to be designated 'STERILE'.

NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designating that a medical device is 'STERILE' is permissible when a validated manufacturing and sterilization process has been applied. Requirements for validation and routine control of aseptic processes are specified in EN ISO 13408-1. Specific requirements for the aseptic processing of solid medical devices and combination products are specified in ISO 13408-7.


Cross References:
EN ISO 11135:2014
ISO 11135:2014
EN ISO 11137-1:2015
SO 11137-1:2006/Amd 1:2013
EN ISO 13408-2:2011
ISO 13408-2:2003
EN ISO 13408-5:2011
ISO 13408-5:2006
EN ISO 13485:2012
ISO 13485:2003
EN ISO 14160:2011
ISO 14160:2011
EN ISO 14937:2009
ISO 14937:2009
EN ISO 17665-1:2006
ISO 17665-1:2006
EN ISO 20857:2013
ISO 20857:2010
EN ISO 25424:2011
ISO 25424:2009
EN 556-1:2001
EN ISO 9001
ISO 9001
EN ISO 11137-2
ISO 11137-2
EN ISO 11137-3
ISO 11137-3
EN ISO 11737-1
ISO 11737-1
EN ISO 11737-2
ISO 11737-2
EN ISO 13408-1:2015
ISO 13408-1:2008/Amd 1:2013
EN ISO 13408-3
ISO 13408-3
EN ISO 13408-4
ISO 13408-4
EN ISO 13408-6
ISO 13408-6
EN ISO 14971
ISO 14971
EN ISO 15223-1
ISO 15223-1
EN ISO 17664
ISO 17664
ISO 13408-7:2012
ISO/TS 11139:2006
CEN ISO/TS 17665-2
ISO/TS 17665-2
90/385/EEC
93/42/EEC
98/79/EC


All current amendments available at time of purchase are included with the purchase of this document.
 

Product Details

Published:
09/30/2015
ISBN(s):
9780580809613
Number of Pages:
20
File Size:
1 file , 1000 KB
Product Code(s):
30273162, 30273162, 30273162
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This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. BS EN 556-2:2015

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    Sterilization of medical devices. Requirements for medical devices to be designated "STERILE"-Requirements for aseptically processed medical devices

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  2. BS EN 556-2:2003


    Sterilization of medical devices. Requirements for medical devices to be designated "STERILE"-Requirements for aseptically processed medical devices

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