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BS EN 556-2:2003

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

standard by British-Adopted European Standard , 01/31/2004

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Full Description

BS EN 556-2:2003 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 only permissible when a validated sterilization process has been applied. Requirements for validation and routine control of aseptic processes are specified in prEN 13824 (in preparation).

Cross References:
90/385/EEC
93/42/EEC
98/79/EC
EN 556-1
EN 980
prEN 13824
EN ISO 9001:2000
ISO 9001:2000
EN ISO 13488
ISO 13488:1996
EN ISO 14160:1998
ISO 14160:1998
EN ISO 14937:2000
ISO 14937:2000
EN ISO14971
ISO 14971:2000
European Pharmacopoeia 4
EN 550
EN 552
EN 554
EN ISO 13485
ISO 13485:2003
 

Product Details

Published:
01/31/2004
ISBN(s):
0580432130
Number of Pages:
12
File Size:
1 file , 140 KB
Product Code(s):
30055793, 30055793, 30055793
Note:
This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. BS EN 556-2:2015


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

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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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