BS EN 556-1:2001
Superseded
View Superseded by
Sterilization of medical devices. Requirements for medical devices to be designated \'STERILE\' Part 1. Requirements for terminally sterilized medical devices
Hardcopy , PDF
English
30-11-2006
03-07-2024
| Committee |
CH/198
|
| DevelopmentNote |
Supersedes 99/565209 DC and BS EN 556 (12/2001)
|
| DocumentType |
Standard
|
| Pages |
12
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
This European Standard specifies the requirements for a terminally-sterilized medical device to be designated \'STERILE\'. Part2 of this European Standard 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), designation of a medical device as \'STERILE\' is only permissible when a validated sterilization process has been applied. Requirements for validation and routine control of processes for the sterilization of medical devices are specified in EN550 , EN552 , EN554 , EN ISO14160 and EN ISO14937.
| Standards | Relationship |
| NBN EN 556-1 : 2001 COR 2006 | Identical |
| NF EN 556-1 : 2002 | Identical |
| NEN EN 556-1 : 2001 C1 2006 | Identical |
| DIN EN 556-1:2002-03 | Identical |
| NS EN 556-1 : 2002 AC 2006 | Identical |
| I.S. EN 556-1:2002 | Identical |
| EN 556-1:2001 | Identical |
| EN 556-1:2001/AC:2006 | Identical |
| UNE-EN 556-1:2002 | Identical |
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