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Standard
ISO 20688-2
First edition
Biotechnology — Nucleic acid
2024-03
synthesis —
Part 2:
Requirements for the production
and quality control of synthesized
gene fragments, genes, and
genomes
Reference number
ISO 20688-2:2024(en) © ISO 2024
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ISO 20688-2:2024(en)
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Published in Switzerland
© ISO 2024 – All rights reserved
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ISO 20688-2:2024(en)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements for quality management . 3
4.1 General requirements .3
4.2 Control of documents .4
4.3 Quality management system .5
4.4 Biorisk management and safety control .5
5 Requirements for resource management . 5
5.1 Facilities and environmental condition . .5
5.2 Equipment and instruments.5
5.3 Raw materials .6
5.4 Personnel .6
6 Biosafety and biosecurity requirements . 6
6.1 General .6
6.2 DNA sequence screening mechanism .6
7 Requirements for quality control in production .
...