ISO 20688-2:2024
(Main)Biotechnology — Nucleic acid synthesis — Part 2: Requirements for the production and quality control of synthesized gene fragments, genes, and genomes
Biotechnology — Nucleic acid synthesis — Part 2: Requirements for the production and quality control of synthesized gene fragments, genes, and genomes
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 the 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.
Titre manque — Partie 2: Titre manque
General Information
Buy Standard
Standards Content (Sample)
International
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)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2024
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
© ISO 2024 – All rights reserved
ii
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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 .
...
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 20688-2
ISO/TC 276
Biotechnology — Nucleic acid
Secretariat: DIN
synthesis —
Voting begins on:
2023-12-08
Part 2:
Voting terminates on:
Requirements for the production and
2024-02-02
quality control of synthesized gene
fragments, genes, and genomes
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 20688-2:2023(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. © ISO 2023
---------------------- Page: 1 ----------------------
ISO/FDIS 20688-2:2023(E)
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 20688-2
ISO/TC 276
Biotechnology — Nucleic acid
Secretariat: DIN
synthesis —
Voting begins on:
Part 2:
Voting terminates on:
Requirements for the production and
quality control of synthesized gene
fragments, genes, and genomes
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
RECIPIENTS OF THIS DRAFT ARE INVITED TO
ISO copyright office
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
CP 401 • Ch. de Blandonnet 8
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
CH-1214 Vernier, Geneva
DOCUMENTATION.
Phone: +41 22 749 01 11
IN ADDITION TO THEIR EVALUATION AS
Reference number
Email: copyright@iso.org
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 20688-2:2023(E)
Website: www.iso.org
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
Published in Switzerland
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
ii
© ISO 2023 – All rights reserved
NATIONAL REGULATIONS. © ISO 2023
---------------------- Page: 2 ----------------------
ISO/FDIS 20688-2:2023(E)
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.
...
© ISO 2023 – All rights reserved
ISO/DIS FDIS 20688-2:2023(E)
Date: 2023-05-09
ISO/TC 276/WG 3
Secretariat: DIN
Date: 2023-11-23
Biotechnology — Nucleic acid synthesis — Part 2: Requirements for the
production and quality control of synthesized gene fragments, genes and
genomes
DIS stage
© ISO 2023 – All rights reserved 1
---------------------- Page: 1 ----------------------
ISO/FDIS 20688-2:2023(E)
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no
part of this publication may be reproduced or utilized otherwise in any form or by any means,
electronic or mechanical, including photocopying, or posting on the internet or an intranet, without
prior written permission. Permission can be requested from either ISO at the address below or
ISO’s member body in the country of the requester.
ISO Copyright Office
CP 401 • CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
Email: copyright@iso.org
Email: copyright@iso.org
Website: www.iso.orgwww.iso.org
Published in Switzerland.
ii © ISO 2023 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/FDIS 20688-2:2023(E)
Contents Page
Foreword . viii
Introduction . ix
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements for quality management . 4
4.1 General requirements . 4
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 . 6
5.3 Raw materials . 6
5.4 Personnel . 6
6 Biosafety and biosecurity requirements . 7
6.1 General . 7
6.2 DNA sequence screening mechanism . 7
7 Requirements for quality control in production . 8
7.1 General . 8
7.2 Quality control in synthetic gene fragments production . 8
7.2.1 General . 8
7.2.2 Sequence design . 8
7.2.3 Assembly .
...
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