07.080 - Biology. Botany. Zoology

This document specifies process and quality requirements for the biobanking of mammalian (including human) cell lines. It describes requirements for the fundamental procedures of the biobank handling cell lines, such as establishment, reception, identification, propagation, preservation, storage, quality control, and distribution of cell lines. This document can be used by organizations performing biobanking activities with mammalian cell lines used for research and development, biobank users, o...view more

This document specifies requirements for data management and publication in microbial resource centres (MRCs) to enable consistent formatting, and a quality control workflow to improve the overall quality of data. It also provides recommendations for MRCs to improve data sharing and integration of microbial material and associated data. This document is intended to facilitate procedures such as accessioning, acquisition, authentication, preservation, storage, and distribution, and can be used by...view more

This document specifies general requirements for the competence, impartiality and consistent operation of biobanks including quality control requirements to ensure biological material and data collections of appropriate quality.
This document is applicable to all organizations performing biobanking, including biobanking of biological material from multicellular organisms (e.g. human, animal, fungus and plant) and microorganisms for research and development.
Biobank users, regulatory authoritie...view more

This document specifies general requirements and reviews the points to consider for the transportation of cells for therapeutic use, including storage during transportation. Transportation starts from the transfer of the packaged cells by the sender to the transportation service provider and ends when the package is delivered to the receiver at its destination. This document does not apply to transportation of cells within one facility. This document includes the development of a transportation ...view more

This document specifies the validation and verification requirements applicable to a biobank to be able to demonstrate that it operates its processing of biological materials with validated and/or verified methods that are fit for purpose. This document is intended for use in the implementation and validation of processing methods for biological materials. This document covers method validation and verification for the production of all biological materials. This document does not apply to biolo...view more

This document provides guidance to biobanks on how to implement the quality management, management, and technical requirements of ISO 20387. It expands on aspects of ISO 20387 and provides examples for illustration purposes. The aim of this document is to assist biobanks to address competency of personnel and appropriate quality of biological material and data collections. This document is equally applicable to newly established and existing biobanks. This document is applicable to all organizat...view more

This document describes prototypes of the Ontology-Enhanced Thesaurus (OET) and the Keyword Explorer interface to OET. Although their design philosophy is described, this document focuses on their value and how they work.

This document specifies minimum requirements for the production and quality control of synthesized oligonucleotides (nominally up to 250 bases). This document also describes general quality attributes for synthesized oligonucleotides as well as common methods for evaluating quality attributes.

This document provides a method for evaluating aspects of the quality of a cell counting measurement process for a specific cell preparation through a set of quality indicators derived from a dilution series experimental design and statistical analysis. The quality indicators are based on repeatability of the measurement and the degree to which the results conform to an ideal proportional response to dilution. This method is applicable to total, differential, direct and indirect cell counting me...view more

This document provides generic requirements for evaluating the performance and ensuring the quality of methods used for the quantification of specific nucleic acid sequences (targets). This document is applicable to the quantification of DNA (deoxyribonucleic acid) and RNA (ribonucleic acid) target sequences using either digital (dPCR) or quantitative real-time PCR (qPCR) amplification technologies. It applies to target sequences present in nucleic acid molecules including double-stranded DNA (d...view more

This document provides guidance for ancillary material (AM) users. It is applicable to cellular therapeutic products, including those gene therapy products whereby cells form part of the final product. It does not apply to products without cells. This document focuses primarily on ancillary materials (AMs) of biological (human and animal) origin and their potential impurities and contaminants. NOTE 1 The decision chart in Figure 1 illustrates the rationale underlying the scope of this document. ...view more

This document specifies definitions and general requirements for ancillary materials (AMs) used in cell processing of cellular therapeutic products. This document is applicable to cellular therapeutic products, including those gene therapy products whereby cells form part of the final product. It does not apply to products without cells. This document does not cover the selection, assessment or control of starting materials and excipients. NOTE International, regional or national regulations or ...view more

This document provides guidance for ancillary material (AM) suppliers to maintain a high level of lot-to-lot consistency in the aspects of identity, purity, stability, biosafety, performance, as well as the accompanying documentation. This document is applicable to cellular therapeutic products, including gene therapy products whereby cells form part of the final product. It does not apply to products without cells. The AMs described in this document include those of biological origin [e.g. sera...view more

This document specifies general requirements for the competence, impartiality and consistent operation of biobanks including quality control requirements to ensure biological material and data collections of appropriate quality. This document is applicable to all organizations performing biobanking, including biobanking of biological material from multicellular organisms (e.g. human, animal, fungus and plant) and microorganisms for research and development. Biobank users, regulatory authorities,...view more

ISO 20391-1:2018 defines terms related to cell counting for biotechnology. It describes counting of cells in suspension (generally cell concentration) and cells adhered to a substrate (generally area density of cells). It provides key considerations for general counting methods (including total and differential counting, and direct and indirect counting) as well as for method selection, measurement process, and data analysis and reporting. ISO 20391-1:2018 is applicable to the counting of all ce...view more

ISO 18457:2016 provides a framework of biomimetics for the development of materials, structures, surfaces, components, and manufacturing technologies. ISO 18457:2016 specifies the principles of biological systems, and especially the performance of biological materials, structures, surfaces, components, and manufacturing technologies that provide the motivation and reasons for biomimetic approaches. It specifies the methodology based on analysis of biological systems, which lead to analogies, and...view more

This Technical Specification describes a procedure for the use of the passive samplers Sigma-2 and PMF to sample airborne pollen. Both are designed to sample coarse aerosol particles. Collected samples are used to analyze pollen input with regard to pollen type and amount, and input of transgenic pollen. The Sigma-2 passive sampler here provides a standardized sampling method for direct microscopic pollen analysis and quantifying the aerial pollen input at the site. The PMF yields sufficient amo...view more

This Technical Specification describes a procedure through which pollen – in particular pollen of genetically modified organisms (GMO) – can be sampled by means of bee colonies.
Bee colonies, especially the foraging bees, actively roam an area and are therefore area related samplers. Pollen sampling depends on the collection activity of the bees and the availability of pollen sources within the spatial zone according to the bees' preferences (supply of melliferous plants). A colony of bees norm...view more

ISO 18458:2015 provides a framework for the terminology on biomimetics in scientific, industrial, and educational purposes. ISO 18458:2015 is intended to provide a suitable framework for biomimetic applications. The field of biomimetics is classified and defined, numerous terms are described, and a description of the process of applying biomimetic methods from the development of new ideas to the biomimetic product is provided. The limits and potential of biomimetics as an innovation approach or ...view more

ISO 18459:2015 specifies the functions and scopes of biomimetic structural optimization methods. They consider linear structural problems under static and fatigue loads. The methods described in ISO 18459:2015 are illustrated by examples. The purpose of ISO 18459:2015 is to familiarize users with biomimetic optimization methods as effective tools for increasing the lifespan, reducing the weight of components, and promoting the widespread use of these methods in support of sustainable development...view more