ISO/PWI 20688-3

Biotechnology — Nucleic acid synthesis — Part 3: Screening requirements for ensuring biosafety and biosecurity

Апстракт

This standard provides implementation guidance for the biosafety and biosecurity requirements for the safe production and quality control of synthesized nucleic acids including fragments, genes and genomes. It describes recommended approaches and implementation considerations for nucleic acid sequence screening and associated biosecurity measures intended to reduce the risk of the intentional or inadvertent misuse of nucleic acid synthesis technologies and products.
It applies to producers of synthetic nucleic acids, including DNA (single stranded and double-stranded) and RNA, covering organizations using in-house (including benchtop) or third-party production systems. It covers practical considerations relating to sequence screening, customer verification, and confirming intended end use, as well as procedures and practices for escalation and reporting, recordkeeping and traceability, cybersecurity and information security, assurance and oversight, and the governance of implementation over time.
This document also covers implementation considerations related to the identification and handling of sequences of concern, including function-based and beyond-list approaches, translated screening, minimum screening length, treatment of fragmented or distributed orders, exempted sequences, third parties and intermediaries, user responsibilities, and benchtop nucleic acid synthesis equipment.
It is intended for use by nucleic acid synthesis providers, screening service providers, auditors, biosafety and biosecurity practitioners, standards bodies, and competent authorities in research, commercial, industrial, and academic settings.