ISO 10993-7:2008
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
Hardcopy , PDF
13-10-2008
20-04-2026
ISO 10993-7:2008 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 the standard is applied are also included in informative annexes.
EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by ISO 10993-7:2008.
| Committee |
ISO/TC 194
|
| DevelopmentNote |
Supersedes ISO/DIS 10993-7. (10/2008) NEW CHILD AMD 1 2019 IS NOW ADDED.
|
| DocumentType |
Standard
|
| Pages |
86
|
| ProductNote |
NEW CHILD AMD 1 2019 IS NOW ADDED.
|
| PublisherName |
International Organization for Standardization
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NEN-EN-ISO 10993-7 : 2008 | Identical |
| DIN EN ISO 10993-7:2009-02 | Identical |
| NF EN ISO 10993-7 : 2008 | Identical |
| GOST ISO 10993-7 : 2011 | Identical |
| SS-EN ISO 10993-7:2008 | Identical |
| PN-EN ISO 10993-7: 2009 | Identical |
| I.S. EN ISO 10993-7:2008 | Identical |
| GOST R ISO 10993-7 : 2009 | Identical |
| NS EN ISO 10993-7 : 2008 AC 2009 | Identical |
| EN ISO 10993-7 : 2008 COR 2009 | Identical |
| NBN EN ISO 10993-7 : 2008 COR 2009 | Identical |
| IS/ISO 10993 : Part 7 : 2008 | Identical |
| JIS T 0993-7:2012 | Identical |
| EN ISO 10993-7:2008 | Identical |
| BS EN ISO 10993-7:2008 | Equivalent |
| IS 17932 : Part 5 : 2024 | Identical |
| AAMI ISO 10993-7 : 2008 | Identical |
| AAMI TIR19 : 1998 | Identical |
| NBR ISO 10993-7 : 2005 | Identical |
| CSA ISO 10993-7 : 1998 | Identical |
| AAMI ISO 10993-7:2008(R2012) | Identical |
| UNE-EN ISO 10993-7:2009 | Identical |
| SAC GB/T 16886.7 : 2001 | Identical |
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