<p><span lang="EN-GB">This document specifies allowable limits (AL) for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining conformity so that devices can be released. Additional background, including guidance and a flowchart showing how this document is applied, are also included in </span>Annexes A<span lang="EN-GB">, </span>B<span lang="EN-GB">, </span>C<span lang="EN-GB">, </span>D<span lang="EN-GB">, </span>E<span lang="EN-GB">, </span>F<span lang="EN-GB">, </span>G<span lang="EN-GB">, </span>H<span lang="EN-GB">, </span>I<span lang="EN-GB">, </span>J<span lang="EN-GB"> and </span>K<span lang="EN-GB">.</span></p>
<p><span lang="EN-GB">EO-sterilized devices or components that have neither direct nor indirect body or user contact (e.g. in vitro diagnostic devices) are out of scope of this document. This document does not apply to devices that have been demonstrated to not absorb or retain EO or its degradation product ECH, such as medical devices made exclusively of metal alloys and glass, see </span>Clause C.5<sup>[228]</sup><span lang="EN-GB">.</span></p>
<p><span lang="EN-GB">NOTE This document does not specify limits for ethylene glycol (EG). No device limits are specified for EG because the risk assessment in </span>Annex F<span lang="EN-GB"> indicates that calculated allowable levels are higher than those likely to occur in a medical device.</span></p>
Registration number (WIID)
84824
Scope
<p><span lang="EN-GB">This document specifies allowable limits (AL) for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining conformity so that devices can be released. Additional background, including guidance and a flowchart showing how this document is applied, are also included in </span>Annexes A<span lang="EN-GB">, </span>B<span lang="EN-GB">, </span>C<span lang="EN-GB">, </span>D<span lang="EN-GB">, </span>E<span lang="EN-GB">, </span>F<span lang="EN-GB">, </span>G<span lang="EN-GB">, </span>H<span lang="EN-GB">, </span>I<span lang="EN-GB">, </span>J<span lang="EN-GB"> and </span>K<span lang="EN-GB">.</span></p>
<p><span lang="EN-GB">EO-sterilized devices or components that have neither direct nor indirect body or user contact (e.g. in vitro diagnostic devices) are out of scope of this document. This document does not apply to devices that have been demonstrated to not absorb or retain EO or its degradation product ECH, such as medical devices made exclusively of metal alloys and glass, see </span>Clause C.5<sup>[228]</sup><span lang="EN-GB">.</span></p>
<p><span lang="EN-GB">NOTE This document does not specify limits for ethylene glycol (EG). No device limits are specified for EG because the risk assessment in </span>Annex F<span lang="EN-GB"> indicates that calculated allowable levels are higher than those likely to occur in a medical device.</span></p>
