BS EN ISO 10993-7:2008
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Biological evaluation of medical devices Ethylene oxide sterilization residuals
Hardcopy , PDF
English
31-07-2010
26-01-2022
| Committee |
CH/194
|
| DevelopmentNote |
Supersedes 93/500349 DC. (11/2005) Supersedes 06/30097290 DC. (12/2008)
|
| DocumentType |
Standard
|
| Pages |
98
|
| PublisherName |
British Standards Institution
|
| Status |
Withdrawn
|
| Supersedes |
This part of ISO10993 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining compliance so that devices may be released. Additional background, including guidance and a flowchart showing how this document is applied, are also included in the informative annexes.
EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by this part of ISO10993.
NOTE This part of ISO10993 does not specify limits for ethylene glycol (EG).
| Standards | Relationship |
| NS EN ISO 10993-7 : 2008 AC 2009 | Identical |
| NF EN ISO 10993-7 : 2008 | Identical |
| DIN EN ISO 10993-7:2009-02 | Identical |
| NEN EN ISO 10993-7 : 2008 C1 2009 | Identical |
| EN ISO 10993-7 : 2008 COR 2009 | Identical |
| NBN EN ISO 10993-7 : 2008 COR 2009 | Identical |
| I.S. EN ISO 10993-7:2008 | Identical |
| ISO 10993-7:2008/Cor 1:2009 | Identical |
| ISO 10993-7:2008 | Equivalent |
| EN ISO 10993-7:2008 | Equivalent |
| EN ISO 10993-7:2008/AC:2009 | Identical |
| UNE-EN ISO 10993-7:2009 | Identical |
This standard has been withdrawn and is no longer current. No replacement edition is available.
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