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<p>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.</p>
<p>EO-sterilized devices that have no patient contact (e.g., <i>in vitro</i> diagnostic devices) are not covered by ISO 10993-7:2008.</p>
Reģistrācijas numurs (WIID)
84824
Darbības sfēra
<p>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.</p>
<p>EO-sterilized devices that have no patient contact (e.g., <i>in vitro</i> diagnostic devices) are not covered by ISO 10993-7:2008.</p>
