Biotechnology — Data publication — Preliminary considerations and concepts

Biotechnology — Genome editing — Part 1: Vocabulary

Biotechnology — Genome editing — Part 1: Vocabulary — Amendment 1

Biotechnology — Data interoperability for Stem Cell — Part 1: Framework

Biotechnology — Recommendations and requirements for predictive computational models in personalized medicine research — Part 1: Guidelines for constructing, verifying and validating models

Biotechnology — Biobanking — General requirements for biobanking

Biotechnology — Biobanking — Requirements for animal biological material

Biotechnology — Cell counting — Part 1: General guidance on cell counting methods

Biotechnology — Cell counting — Part 2: Experimental design and statistical analysis to quantify counting method performance

Biotechnology — Requirements for evaluating the performance of quantification methods for nucleic acid target sequences — qPCR and dPCR

Biotechnology — Massively parallel sequencing — Part 1: Nucleic acid and library preparation

Biotechnology — Massively parallel sequencing — Part 2: Quality evaluation of sequencing data

Biotechnology — Ancillary materials present during the production of cellular therapeutic products — Part 1: General requirements

Biotechnology — Ancillary materials present during the production of cellular therapeutic products — Part 2: Best practice guidance for ancillary material suppliers

Biotechnology — Ancillary materials present during the production of cellular therapeutic products — Part 3: Best practice guidance for ancillary material users

Biotechnology — Ancillary materials present during the production of cellular therapeutic products and gene therapy products

Biotechnology — Bioprocessing — General requirements for the design of packaging to contain cells for therapeutic use

Biotechnology — Nucleic acid synthesis — Part 1: Requirements for the production and quality control of synthesized oligonucleotides

Biotechnology — Nucleic acid synthesis — Part 2: General definitions and requirements for the production and quality control of synthesized gene fragment, gene, and genome

Biotechnology — Requirements for data formatting and description in the life sciences

Biotechnology — Biobanking — Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines

Biotechnology — Biobanking — Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines — Amendment 1

Biotechnology — Specification on data management and publication in microbial resource centers

Biotechnology — Biobanking — General requirements for the validation and verification of processing methods for biological material in biobanks

Biotechnology — General requirements for transportation of cells for therapeutic use

Biotechnology — Biobanking — Implementation guide for ISO 20387

Biotechnology — Biobanking — Requirements for human mesenchymal stromal cells derived from umbilical cord tissue

Biotechnology — Analytical methods — General requirements and considerations for the testing and characterization of cellular therapeutic products

Biotechnology — Biobanking — Requirements for the biobanking of plant biological material for research and development

Biotechnology — Provenance information model for biological material and data — Part 1: Design concepts and general requirements

Biotechnology — General requirements and considerations for cell line authentication

Biotechnology — Bioprocessing — General requirements and considerations for equipment systems used in the manufacturing of cells for therapeutic use

Biotechnology — Biobanking of microorganisms — Part 1: Bacteria and archaea

Biotechnology — Analytical Methods — Risk-based approach for method selection and validation for rapid microbial detection in bioprocesses

Biotechnology — Massively parallel DNA sequencing — General requirements for data processing of shotgun metagenomics

Biotechnology — Minimum requirements for optical signal measurements in photometric methods for biological samples

Biotechnology — Minimum requirements for cellular morphological analysis — Image capture, image processing, and morphometry

Biotechnology — Validation of Database used for nucleotide sequence evaluation

Biotechnology — Biobanking — Requirements for human and mouse pluripotent stem cells

Biotechnology — Biobanking — Requirements for human mesenchymal stromal cells derived from bone marrow