scope:

This document specifies the general definitions and requirements for production and quality control of synthesized double-stranded DNA. This document describes the general requirements for quality management, resource management, biosafety and biosecurity, and quality control methods in the production and products, the 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 is intended to be used by synthetic DNA producers during the manufacturing process for quality control to improve the quality of their products, by academic laboratories to evaluate the quality of DNA synthesized in their facilities, and by end users to verify the quality of synthesized gene fragments, genes and genomes provided by manufacturers as required.

For entities handling materials procured and used solely for diagnostic purposes, ISO 15189, ISO 13485 and other clinical and medical devices standards apply first and foremost.