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<p class="MsoBodyText"><span lang="EN-GB">This document specifies the general principle and the technical protocol for the validation of identification methods of microorganisms for microbiology in the food chain. As there is no reference method, no method comparison study can be run. Therefore, this document provides a protocol to evaluate the performance characteristics and validate the method workflow using well-defined strains. When required, an additional identification method can be used.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document is applicable to the validation of identification methods of microorganisms that are used for the analysis of isolated colonies from:</span></p>
<p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="EN-GB">products intended for human consumption;</span></p>
<p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="EN-GB">products for feeding animals;</span></p>
<p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="EN-GB">environmental samples in the area of food and feed production and handling;</span></p>
<p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="EN-GB">samples from the primary production stage.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">Identification methods only validated in accordance with this document cannot be used instead of confirmation described in:</span></p>
<p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="EN-GB">the reference method;</span></p>
<p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="EN-GB">an alternative method validated in accordance with ISO 16140-2;</span></p>
<p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="EN-GB">an alternative method validated in accordance with ISO 16140-6.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">In these instances, the identification method is validated in accordance with ISO 16140-6 method that is used as a confirmation method.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document is applicable to bacteria and fungi. Some clauses can be applicable to other (micro)organisms, which can be determined on a case-by-case basis.</span></p>
Reģistrācijas numurs (WIID)
79100
Darbības sfēra
<p class="MsoBodyText"><span lang="EN-GB">This document specifies the general principle and the technical protocol for the validation of identification methods of microorganisms for microbiology in the food chain. As there is no reference method, no method comparison study can be run. Therefore, this document provides a protocol to evaluate the performance characteristics and validate the method workflow using well-defined strains. When required, an additional identification method can be used.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document is applicable to the validation of identification methods of microorganisms that are used for the analysis of isolated colonies from:</span></p>
<p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="EN-GB">products intended for human consumption;</span></p>
<p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="EN-GB">products for feeding animals;</span></p>
<p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="EN-GB">environmental samples in the area of food and feed production and handling;</span></p>
<p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="EN-GB">samples from the primary production stage.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">Identification methods only validated in accordance with this document cannot be used instead of confirmation described in:</span></p>
<p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="EN-GB">the reference method;</span></p>
<p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="EN-GB">an alternative method validated in accordance with ISO 16140-2;</span></p>
<p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="EN-GB">an alternative method validated in accordance with ISO 16140-6.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">In these instances, the identification method is validated in accordance with ISO 16140-6 method that is used as a confirmation method.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document is applicable to bacteria and fungi. Some clauses can be applicable to other (micro)organisms, which can be determined on a case-by-case basis.</span></p>
