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<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">This document specifies the requirements and test methods for sterilized absorbent points used in endodontic procedures. Absorbent points are marketed sterilized or non-sterilized. The requirements apply to absorbent points which have been sterilized once in a manner approved by the manufacturer. This document specifies numerical systems and a colour-coding system for designating the sizes of absorbent points.</span></p>
<p class="MsoBodyText"><span class="citesec"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">Clause 7</span></span></span><span lang="EN-GB"> specifies the labelling and packaging needed, including the instructions for use. A claim by the manufacturer that the contents of the unopened pack are sterile is the responsibility of the manufacturer (see </span><span class="citetbl"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">Table 2</span></span></span><span lang="EN-GB">). This document does not specify requirements or test methods for sterility.</span></p>
<p class="Note"><span lang="EN-GB">NOTE 1 Reference to applicable national regulations can be made. </span></p>
<p class="MsoBodyText"><span lang="EN-GB">Reference is made to internationally accepted pharmacopoeia. </span></p>
<p class="Note"><span lang="EN-GB">NOTE 2 National requirements can apply.</span></p>
<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">Standards on methods of validating sterilization processes are also available: <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">ISO</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">11137</span></span></span>-<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">1</span></span></span>, <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">ISO</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">11137</span></span></span>-<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">2</span></span></span> and <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">ISO</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">11137</span></span></span>-<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">3</span></span></span>.</span></p>
Reģistrācijas numurs (WIID)
93031
Darbības sfēra
<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">This document specifies the requirements and test methods for sterilized absorbent points used in endodontic procedures. Absorbent points are marketed sterilized or non-sterilized. The requirements apply to absorbent points which have been sterilized once in a manner approved by the manufacturer. This document specifies numerical systems and a colour-coding system for designating the sizes of absorbent points.</span></p>
<p class="MsoBodyText"><span class="citesec"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">Clause 7</span></span></span><span lang="EN-GB"> specifies the labelling and packaging needed, including the instructions for use. A claim by the manufacturer that the contents of the unopened pack are sterile is the responsibility of the manufacturer (see </span><span class="citetbl"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">Table 2</span></span></span><span lang="EN-GB">). This document does not specify requirements or test methods for sterility.</span></p>
<p class="Note"><span lang="EN-GB">NOTE 1 Reference to applicable national regulations can be made. </span></p>
<p class="MsoBodyText"><span lang="EN-GB">Reference is made to internationally accepted pharmacopoeia. </span></p>
<p class="Note"><span lang="EN-GB">NOTE 2 National requirements can apply.</span></p>
<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">Standards on methods of validating sterilization processes are also available: <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">ISO</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">11137</span></span></span>-<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">1</span></span></span>, <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">ISO</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">11137</span></span></span>-<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">2</span></span></span> and <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">ISO</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">11137</span></span></span>-<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">3</span></span></span>.</span></p>
