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<p class="MsoBodyText"><span lang="EN-GB">This document specifies the requirements for the production and quality control of synthesized double-stranded DNA. It describes requirements for quality management, resource management, biosafety and biosecurity, quality control in production, product quality, and delivered product specifications for synthesized gene fragments, genes and genomes.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document is applicable to synthetic gene fragments, genes and genomes with a length below 10 Mbp (base pairs) in the forms of non-clonal fragments (linear) and clonal genes in plasmids (circular).</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document does not provide specific requirements for materials used solely for diagnostic purposes.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">When the synthesized nucleic acids are procured and used for diagnostic purposes, the user can take ISO 15189, ISO 13485 and other related clinical standards into account.</span></p>
Reģistrācijas numurs (WIID)
75852
Darbības sfēra
<p class="MsoBodyText"><span lang="EN-GB">This document specifies the requirements for the production and quality control of synthesized double-stranded DNA. It describes requirements for quality management, resource management, biosafety and biosecurity, quality control in production, product quality, and delivered product specifications for synthesized gene fragments, genes and genomes.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document is applicable to synthetic gene fragments, genes and genomes with a length below 10 Mbp (base pairs) in the forms of non-clonal fragments (linear) and clonal genes in plasmids (circular).</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document does not provide specific requirements for materials used solely for diagnostic purposes.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">When the synthesized nucleic acids are procured and used for diagnostic purposes, the user can take ISO 15189, ISO 13485 and other related clinical standards into account.</span></p>
