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.
This document is applicable to synthetic gene fragments, genes and genomes with a length below 10 Mbp (base pairs) in forms of non-clonal fragments (linear) and clonal genes in plasmids (circular).
This document does not provide specific requirements for materials used solely for diagnostic purposes.
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.