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