SS-EN-ISO-10993-7 › Historical Revision Information
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10 993-7:1995)
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This part of ISO 10993 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 and guidance also is included in informative annexes. EO-sterilized devices that have no patient contact (e.g. in vitro diagnostic devices) are not covered by this International Standard.
To find similar documents by classification:
11.100.20 (Biological evaluation of medical devices Medical microbiology, see 07.100.10)
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Designation Name
SS-EN ISO 10993-7
Revision Level
EDITION 1
Status
Superseded
Publication Date
Dec. 1, 1995
Language(s)
English
Page Count
48
International Equivalent
EN ISO 10993-7:1995(IDT); ISO 10 993-7:1995(IDT)