07.080 - Biology. Botany. Zoology
ICS 07.080 Details
Biology. Botany. Zoology
Biologie. Botanik. Zoologie
Biologie. Botanique. Zoologie
Biologija. Botanika. Zoologija
General Information
Frequently Asked Questions
ICS 07.080 is a classification code in the International Classification for Standards (ICS) system. It covers "Biology. Botany. Zoology". The ICS is a hierarchical classification system used to organize international, regional, and national standards, facilitating the search and identification of standards across different fields.
There are 289 standards classified under ICS 07.080 (Biology. Botany. Zoology). These standards are published by international and regional standardization bodies including ISO, IEC, CEN, CENELEC, and ETSI.
The International Classification for Standards (ICS) is a hierarchical classification system maintained by ISO to organize standards and related documents. It uses a three-level structure with field (2 digits), group (3 digits), and sub-group (2 digits) codes. The ICS helps users find standards by subject area and enables statistical analysis of standards development activities.
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This document defines terms related to gene transfer for mammalian systems, including the use of viral and non-viral gene delivery systems and via mechanical mechanisms. This document is applicable to the development, measurement, and use of gene delivery systems for all applications.
- Standard12 pagesEnglish languagesale 15% off
This document provides a mapping between the ISO/IEC 11179-34 metamodel for computable data registration and the IEEE 2791 standard for bioinformatics analyses generated by high-throughput sequencing (HTS), to facilitate the production of IEEE 2791 objects from instances of ISO/IEC 11179-34 metamodel and the registration of IEEE 2791 objects as computable data within an MDR conforming to ISO/IEC 11179-34. This document is applicable to those who are submitting data to organizations that require metadata submissions in IEEE 2791 compliant format, as well as those aiming to register IEEE 2791 objects into an MDR that conforms to ISO/IEC 11179-34.
- Standard50 pagesEnglish languagesale 15% off
This document specifies requirements for the biobanking of deep-sea biological material including the collection, processing, transportation and storage of deep-sea biological material. This document is applicable only to deep-sea biological material that can be used for biomolecular processing, e.g. nucleic acids, proteins, and metabolites. This document is applicable to all organizations performing research and development on deep-sea biological material. This document does not apply to the collection of deep-sea biological material intended for environmental impact assessment for sea floor mining. NOTE International, national or regional regulations or requirements or a multiple of these can also apply to specific topics covered in this document.
- Standard12 pagesEnglish languagesale 15% off
This document specifies the minimum requirements for BSC with respect to design, construction, safety and hygiene and gives general test methods for their verification.
The requirements for the different classes are given in the respective parts of EN 12469.
- Standard24 pagesEnglish languagee-Library read for1 day
This document gives requirements and recommendations for installation, commissioning and routine testing of BSC.
- Standard16 pagesEnglish languagee-Library read for1 day
This document specifies the specific requirements for class II BSC with respect to design, construction, safety and hygiene.
It sets the specific performance criteria for class II BSC for work with biological agents and specifies test procedures with respect to protection of the worker, the environment and product protection including cross-contamination.
- Standard43 pagesEnglish languagee-Library read for1 day
This document specifies requirements for primary containers intended for the storage of biological materials in biobanks. In addition to general requirements, this document also specifies special requirements depending on the storage conditions, the biological material and the intended use, as well as requirements for documentation and quality control. These requirements establish the framework for ensuring that primary containers meet the necessary quality criteria. This document specifies test criteria and test methods that enable proof of conformity with the requirements. This document is primarily aimed at manufacturers that produce primary containers for the storage of biological materials. Biobanks, submitters and users of biological material, and organizations that monitor or control the work of biobanks can also use this document. NOTE For primary containers intended for biological material for therapeutic use, other requirements can apply.
- Standard16 pagesEnglish languagesale 15% off
This document specifies the minimum requirements for BSC with respect to design, construction, safety and hygiene and gives general test methods for their verification.
The requirements for the different classes are given in the respective parts of prEN 12469.
- Standard24 pagesEnglish languagee-Library read for1 day
This document gives requirements and recommendations for installation, commissioning and routine testing of BSC.
- Standard16 pagesEnglish languagee-Library read for1 day
This document specifies the specific requirements for class II BSC with respect to design, construction, safety and hygiene.
It sets the specific performance criteria for class II BSC for work with biological agents and specifies test procedures with respect to protection of the worker, the environment and product protection including cross-contamination.
- Standard43 pagesEnglish languagee-Library read for1 day
This document specifies general requirements and guidance for metagenomics-dedicated sample preparation, and generating and analysing metagenomics sequence data obtained from massive parallel sequencing platforms. The specified metagenomics process includes the following stages: a) sampling strategy and process, including type, storage, transportation, extraction, quality; b) nucleic acid library preparation c) design and review process including sequencing strategy and assessment; d) database construction; e) bioinformatics analysis and report f) validation and verification for bioinformatics pipeline, and database This document applies to laboratories and research organizations.
- Standard17 pagesEnglish languagesale 15% off
This document provides an inventory of methods for the detection of microbiological contamination in mammalian cell culture. This document includes considerations for the selection of methods to test the presence of common contaminants such as bacteria, fungi, viruses and mycoplasma. This document is not applicable to prions and protists. This document is intended for use by biomedical researchers, biobank operators and others performing mammalian cell culture.
- Technical report19 pagesEnglish languagesale 15% off
This document specifies requirements for the biobanking of animal germplasm, e.g. semen, embryos, oocytes, gonads and related tissue, including reception, preparation, quality control, storage and distribution. This document is applicable to animal species for food and agriculture. This document is applicable to all organizations performing biobanking of animal biological material and associated data, such as public or private gene banks and germplasm livestock collections centres. NOTE International, national or regional regulations or requirements, or combinations of them, can also apply to specific topics covered in this document.
- Standard12 pagesEnglish languagesale 15% off
This document specifies a method for the extraction and determination of phosphonates (P-PO3) in plant biostimulants using ion chromatography and conductivity detection (IC-CD).
This document is applicable to the blends of fertilizing products where a blend is a mix of at least two of the following component EU fertilising products categories: Fertilizers, Liming Materials, Soil Improvers, Growing Media, Inhibitors, Plant Biostimulants, and where the following category Plant Biostimulants is the highest percentage in the blend by mass or volume, or in the case of liquid form by dry mass. If Plant Biostimulants is not the highest percentage in the blend, the European Standard for the highest percentage of the blend applies. In case a blend of fertilizing products is composed of components in equal quantity or in case the component EU fertilising products used for the blend have identical formulations , the user decides which standard to apply.
- Standard15 pagesEnglish languagee-Library read for1 day
This document specifies the procedure for the determination of dry residue and calculation of the dry matter fraction of plant biostimulants for which the results of performed analysis are to be calculated to the dry matter basis.
This document is applicable to the blends of fertilizing products where a blend is a mix of at least two of the following component EU fertilising products categories: Fertilizers, Liming Materials, Soil Improvers, Growing Media, Inhibitors, Plant Biostimulants, and where the following category Plant Biostimulants is the highest percentage in the blend by mass or volume, or in the case of liquid form by dry mass. If Plant Biostimulants is not the highest percentage in the blend, the European Standard for the highest percentage of the blend applies. In case a blend of fertilizing products is composed of components in equal quantity or in case the component EU fertilising products used for the blend have identical formulations , the user decides which standard to apply.
- Standard12 pagesEnglish languagee-Library read for1 day
This document specifies requirements for the biobanking of human neural stem cells (hPSC-NSCs) derived from human pluripotent stem cells (hPSCs), including the requirements for the differentiaton, culture, characterization, quality control (QC), storage, thawing and transport of hPSC-NSCs. Requirements for the collection of biological source material, the transport to and reception of biological source material and hPSCs at the biobank, as well as the establishment, expansion and QC of hPSCs are covered in ISO 24603. This document is applicable to all organizations performing biobanking of hPSC-NSCs used for research and development in the life sciences. This document does not apply to hPSC-NSCs for the purpose of in vivo application in humans, clinical applications or therapeutic use. NOTE International, national or regional regulations or requirements or multiple of them can also apply to specific topics covered in this document.
- Standard25 pagesEnglish languagesale 15% off
This document specifies a method for the extraction and determination of phosphonates (P-PO3) in plant biostimulants using ion chromatography and conductivity detection (IC-CD).
This document is applicable to the blends of fertilizing products where a blend is a mix of at least two of the following component EU fertilising products categories: Fertilizers, Liming Materials, Soil Improvers, Growing Media, Inhibitors, Plant Biostimulants, and where the following category Plant Biostimulants is the highest percentage in the blend by mass or volume, or in the case of liquid form by dry mass. If Plant Biostimulants is not the highest percentage in the blend, the European Standard for the highest percentage of the blend applies. In case a blend of fertilizing products is composed of components in equal quantity or in case the component EU fertilising products used for the blend have identical formulations , the user decides which standard to apply.
- Standard15 pagesEnglish languagee-Library read for1 day
This document specifies the procedure for the determination of dry residue and calculation of the dry matter fraction of plant biostimulants for which the results of performed analysis are to be calculated to the dry matter basis.
This document is applicable to the blends of fertilizing products where a blend is a mix of at least two of the following component EU fertilising products categories: Fertilizers, Liming Materials, Soil Improvers, Growing Media, Inhibitors, Plant Biostimulants, and where the following category Plant Biostimulants is the highest percentage in the blend by mass or volume, or in the case of liquid form by dry mass. If Plant Biostimulants is not the highest percentage in the blend, the European Standard for the highest percentage of the blend applies. In case a blend of fertilizing products is composed of components in equal quantity or in case the component EU fertilising products used for the blend have identical formulations , the user decides which standard to apply.
- Standard12 pagesEnglish languagee-Library read for1 day
This document describes a practical procedure for nucleotide sequence database evaluation and validation. This document describes minimum requirements for the validation of a nucleotide sequence database. This document is applicable only for databases consisting of entries of nucleotide sequences. This document is not applicable to the general evaluation of the entire database quality including the quality of each data entry. EXAMPLE The use of the validated database is for confirming a representative sequence specificity including primers or probes for qualification and quantification of target nucleic acids by conventional polymerase chain reaction (PCR), quantitative polymerase chain reaction (qPCR), digital polymerase chain reaction (dPCR) and microarray technologies.
- Standard24 pagesEnglish languagesale 15% off
This document provides general requirements for cell morphometry to quantify cell morphological features including cell shape, size and texture. This document addresses aspects of cell image capture using optical microscopy and image processing for morphometry. This document does not address the statistics associated with a morphological analysis of a cellular sample. This document also gives terms and definitions corresponding to cell morphological descriptors, and lists examples and their formulae, that represent quantitative cellular morphological features for evaluation of cell morphology in cell analysis. This document primarily applies to morphological analysis of cultured mammalian cells. This document is not intended for imaging used in clinical diagnostics.
- Standard44 pagesEnglish languagesale 15% off
- Amendment4 pagesEnglish languagee-Library read for1 day
This document specifies a method for the taxonomic identification of a single bivalve or piece of bivalve to the genus or species level using DNA barcoding. It allows the identification of a large number of commercially important bivalve species.
This method was validated on raw mussels. Laboratory experience indicates additional applicability to processed bivalve products, e.g. cold smoked, hot smoked, salted, frozen, cooked, fried, and deep-fried samples.
The described method is usually unsuitable for the analysis of highly processed foods, e.g. tins of mussels, with highly degraded DNA where the fragment lengths are not sufficient for amplification of the target. Furthermore, it is not applicable for complex seafood products containing mixtures of two or more bivalve species.
The identification of bivalve species is carried out by PCR amplification of a segment of the mitochondrial 16S rRNA gene, followed by sequencing of the PCR products and subsequent sequence comparison with entries in databases.
- Standard17 pagesEnglish languagee-Library read for1 day
This document specifies a method for the identification of meat derived from mammals and birds to the level of genus or species and allows the identification of a large number of commercially important as well as exotic meat species using DNA barcoding.
This method was validated on DNA isolated from single pieces of raw meat. This method can also be used for the identification of single meat animal species in some processed products.
The described method is unsuitable for the analysis of highly processed foods with highly degraded DNA where the fragment lengths are not sufficient for amplification of the targets. Furthermore, it is not applicable for complex meat products containing mixtures of two or more meat species.
The identification of meat species is carried out by PCR amplification of either a segment of the mitochondrial cytochrome b gene (cytb) or the cytochrome c oxidase I gene (cox1, syn COI) or both, followed by sequencing of the PCR products and subsequent sequence comparison with entries in databases.
- Standard20 pagesEnglish languagee-Library read for1 day
- Standard20 pagesEnglish languagee-Library read for1 day
This document specifies a framework for data interoperability of data systems, such as databases, data management systems, web interfaces, API, etc. that manage stem cell data. It is applicable to all human stem cell types. This document does not apply to other animal stem cells or plant stem cells. This document specifies considerations and requirements of stem cell data for data interoperability, such as cell characteristics, applied technologies, ethical requirements, and data sharing, analysis, and accessibility. This document describes an interoperable framework for stem cell data, which can be used for existing systems or existing architectures. The intended audiences for this document are data generators, implementors of IT infrastructure to handle the data, data providers and data consumers.
- Standard11 pagesEnglish languagesale 15% off
This document specifies a method for the taxonomic identification of a single bivalve or piece of bivalve to the genus or species level using DNA barcoding. It allows the identification of a large number of commercially important bivalve species.
This method was validated on raw mussels. Laboratory experience indicates additional applicability to processed bivalve products, e.g. cold smoked, hot smoked, salted, frozen, cooked, fried, and deep-fried samples.
The described method is usually unsuitable for the analysis of highly processed foods, e.g. tins of mussels, with highly degraded DNA where the fragment lengths are not sufficient for amplification of the target. Furthermore, it is not applicable for complex seafood products containing mixtures of two or more bivalve species.
The identification of bivalve species is carried out by PCR amplification of a segment of the mitochondrial 16S rRNA gene, followed by sequencing of the PCR products and subsequent sequence comparison with entries in databases.
- Standard17 pagesEnglish languagee-Library read for1 day
This document specifies a method for the identification of meat derived from mammals and birds to the level of genus or species and allows the identification of a large number of commercially important as well as exotic meat species using DNA barcoding.
This method was validated on DNA isolated from single pieces of raw meat. This method can also be used for the identification of single meat animal species in some processed products.
The described method is unsuitable for the analysis of highly processed foods with highly degraded DNA where the fragment lengths are not sufficient for amplification of the targets. Furthermore, it is not applicable for complex meat products containing mixtures of two or more meat species.
The identification of meat species is carried out by PCR amplification of either a segment of the mitochondrial cytochrome b gene (cytb) or the cytochrome c oxidase I gene (cox1, syn COI) or both, followed by sequencing of the PCR products and subsequent sequence comparison with entries in databases.
- Standard20 pagesEnglish languagee-Library read for1 day
- Standard20 pagesEnglish languagee-Library read for1 day
- Amendment4 pagesEnglish languagee-Library read for1 day
This document provides requirements for the biobanking of helminths as parasitic resources including the collection, safeguarding, classification, proliferation, preservation, storage and distribution of helminths. This document sets requirements for the quality of helminths and their associated data, the data collection, and safety management when handling the helminths as a source of human disease infection. This document is applicable to all organizations performing biobanking with helminths used for research and development. NOTE International, national or regional regulations or requirements, or multiple of them, can also apply to specific topics covered in this document.
- Standard18 pagesEnglish languagesale 15% off
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.
- Standard29 pagesEnglish languagesale 15% off
This document specifies minimum requirements to support accurate measurement of optical signals in photometric methods used for qualitative or quantitative characterization of biological samples. This document is applicable to optical signals that are generated, for example, by bioluminescence, chemiluminescence and fluorescence, and optical signals that are detected as changes of light due to absorption. This document addresses the verification of optical signal measurement instruments used in photometric methods for measurement of biological samples including considerations for the use of optical references. This document does not provide sector- or application-specific performance criteria for the workflow of measuring biological samples. When applicable, users can also consult existing sector- or application- specific standards, or both.
- Standard35 pagesEnglish languagesale 15% off
SCOPE
1.1 This document is composed of terms, definitions of terms, descriptions of terms, and acronyms used in ASTM documents related to the field of bioenergy and industrial chemicals from biomass. Terms that are adequately defined in a general dictionary are not defined in this terminology standard.
1.2 This standard includes terminology used in areas related to bioenergy and industrial chemicals from biomass, such as, but not limited to: characterization and identification of biomass, aseptic sampling, preservation of biological samples, sustainability, denatured fuel ethanol, cooking fuels and biomass conversion.
1.2.1 The bylaws for Committee E48 allow the definitions approved in current E48 standards to be added to this terminology standard editorially. The definitions will have an attribution to indicate the standard(s) containing the definition. Subcommittee E48.91 can also develop definitions for the terminology standard. Those definitions will be attributed to the subcommittee.
1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Standard2 pagesEnglish languagesale 15% off
- Standard2 pagesEnglish languagesale 15% off
This document specifies requirements and recommendations for the design, development and establishment of predictive computational models for research purposes in the field of personalized medicine. It addresses the set-up, formatting, validation, simulation, storing and sharing of computational models used for personalized medicine. Requirements and recommendations for data used to construct or required for validating such models are also addressed. This includes rules for formatting, descriptions, annotations, interoperability, integration, access and provenance of such data. This document does not apply to computational models used for clinical, diagnostic or therapeutic purposes.
- Technical specification31 pagesEnglish languagesale 15% off
SCOPE
1.1 This terminology document defines terms commonly used in standards developed by ASTM Subcommittee E50.47 on Biological Effects and Environmental Fate. This terminology document is intended to be consistent with the use of terms in ASTM standards related to this field and, to the extent possible, with use by other organizations.
1.1.1 If a specific Subcommittee E50.47 standard uses one of these terms in a different context, then the term should be defined in that standard. A term used only in a specific ASTM standard need not be included in this terminology document.
1.2 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Standard3 pagesEnglish languagesale 15% off
This document provides guidance, a framework and a risk-based approach for the selection and validation of methods for rapid microbial detection in cellular therapeutic product manufacturing. This document provides a flexible risk-based framework for the detection of microbial contamination in cellular therapeutic products and cellular intermediates. This document provides general requirements and risks associated with cellular therapeutic product manufacturing, with flexibility to address differences in specific manufacturing processes of each unique cellular therapeutic product. This document primarily addresses sterility testing in cellular therapeutic product manufacturing. This document is applicable to other cell-derived therapeutic product manufacturing. This document focuses on rapid microbial test methods (RMTMs) used for both in-process and final product testing. Viral testing in cellular therapeutic product manufacturing is not included in this document.
- Standard44 pagesEnglish languagesale 15% off
This document illustrates the workflow of shotgun metagenomic sequence data processing of host-derived microbiome and environmental metagenomes. This document specifies the requirements for quality control of shotgun metagenomic sequence data processing for massively parallel DNA sequencing. This document provides guidelines for data directory, data archive and metadata for shotgun metagenomic sequence data. This document applies to data storage, sharing and interoperability of shotgun metagenomic sequence data. This document applies to shotgun metagenomic sequence data processing and analyses, but excludes functional analysis.
- Technical specification18 pagesEnglish languagesale 15% off
This document defines terms related to cell line authentication in the field of biotechnology. It describes the general principles, detection strategies and analytical methods for cell line authentication. It specifies requirements and key considerations for method selection, quality control parameters, data analysis and reporting. This document is applicable to routine inspection of cell lines in culture and in storage in the fields of basic research, translational studies and product manufacturing. It is also applicable to cell line origin validation in academic and industrial laboratories, cell banks and manufacturing sites. It is primarily applicable to mammalian cells, including human cells. This document does not apply to non-animal cells (e.g. microbial contamination, plant cells), nor to cells in complex matrices (e.g. tissues, organs, organoids, plants).
- Technical specification18 pagesEnglish languagesale 15% off
This document specifies general requirements and considerations for the design of packaging used to contain cells for therapeutic use. This document is applicable to packaging intended to contain the final products of cells for therapeutic use, as well as their starting and intermediate materials. This document does not apply to: a) receptacles used for processing cells in manufacturing processes, e.g. cell culture flask or bag; b) shipping containers containing packages for transportation; c) services that utilize packages, e.g. storage services. NOTE 1 Examples of packaging, packages and shipping containers are illustrated in Annex A. NOTE 2 The design of packaging includes processes to ensure that the designed packaging is manufactured to a required specification through trial manufacturing, testing and implementation of quality management. NOTE 3 International, national or regional regulations or requirements can also apply to specific topics covered in this document.
- Standard19 pagesEnglish languagesale 15% off
This document specifies a general concept for a provenance information model for biological material and data and requirements for provenance data interoperability and serialization. The provenance information model covers any information relevant to the quality and fitness for purpose of the biological material generated throughout the preanalytical phase of the materials life cycle from collection to analysis, data originating from analytical procedures applied to the biological material and results from further mathematical processing of the data. This document is applicable to organizations, authorities and industries that are: a) collecting, processing or distributing biological material for research; b) generating, collecting, analysing or storing data on biological material. This document does not apply to biological material and data used for other than research or in fields that are regulated by national, regional or international laws, such as medical diagnosis and therapy or food production. NOTE International, national, or regional regulations or requirements can also apply to specific topics covered in this document.
- Technical specification7 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
5.1 This procedure can be used to limit the need for screening tests prior to performing a test for estimating the LC50 of a non-reactive and non-electrolytic chemical to the fathead minnow. By eliminating the screening test, fewer fish need be tested. The time used for preparing and performing the screening test can also be saved. The value obtained in this procedure can be used as the preliminary estimate of the LC50 in a full-scale test.
5.2 Estimates can be used to set testing priority of groups of non-reactive and non-electrolytic chemicals.
5.3 If the estimated value is more than 0.3 times the experimental value, the mechanism of action is probably narcosis. If less, the effect concentration is considered to reflect a different mechanism of action.
5.4 This practice estimates a maximum LC50, that is, non-reactive and non-electrolytic chemicals are at least as toxic as the practice predicts, but may have a lower LC50 if acting by a more specific mechanism. Data on a chemical indicating a lower toxicity than predicted should be considered suspect or an artifact because of limited solubility of the test material.
SCOPE
1.1 This practice covers a procedure for estimating the fathead minnow (Pimephales promelas) 96-h LC50 of nonreactive (that is, covalently bonded without unsaturated residues) and nonelectrolytic (that is, require vigorous reagents to facilitate substitution, addition, replacement reactions and are non-ionic, non-dissociating in aqueous solutions) organic chemicals acting solely by narcosis, also referred to as Meyer-Overton toxicity relationship.2
1.2 This procedure is accurate for organic chemicals that are toxic due to narcosis and are non-reactive and non-electrolytic. Examples of appropriate chemicals are: alcohols, ketones, ethers, simple halogenated aliphatics, aromatics, and aliphatic substituted aromatics. It is not appropriate for chemicals whose structures include a potential toxiphore (that structural component of a chemical molecule that has been identified to show mammalian toxicity, for example CN is known to be reponsible for inactivation of enzymes, NO2 for decoupling of oxidative phosphorylation, both leading to mammalian toxicity). Examples of chemicals inappropriate for this practice are: carbamates, organophosphates, phenols, beta-gamma unsaturated alcohols, electrophiles, and quaternary ammonium salts.
1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Standard2 pagesEnglish languagesale 15% off
- Standard2 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
5.1 An acute toxicity test is conducted to obtain information concerning the immediate effects on test organisms of a short-term exposure to a test material under specific experimental conditions. An acute toxicity test does not provide information about whether delayed effects will occur, although a post-exposure observation period, with appropriate feeding, if necessary, might provide such information. Bioavailability of the test substance may also differ between real-world exposures and laboratory exposures due to site-specific water quality conditions (see Guides E1192, E1563, and E2455).
5.2 Results of acute toxicity tests might be used to predict acute effects likely to occur on aquatic organisms in field situations as a result of exposure under comparable conditions, except that (1) motile organisms might avoid exposure when possible, and (2) toxicity to benthic organisms might be dependent on sorption or settling of the test material onto the substrate.
5.3 Results of acute tests might be used to compare the acute sensitivities of different species and the acute toxicities of different test materials, and to study the effects of various environmental factors on results of such tests.
5.4 Results of acute toxicity tests might be an important consideration when assessing the hazards of materials to aquatic organisms (see Guide E1023) or when deriving water quality criteria for aquatic organisms (3).
5.5 Results of acute toxicity tests might be useful for studying the biological availability of, and structure-activity relationships between, test materials.
5.6 Results of acute toxicity tests will depend on the temperature, composition of the dilution water, condition of the test organisms, exposure technique, and other factors.
SCOPE
1.1 This guide (1)2 describes procedures for obtaining laboratory data concerning the adverse effects (for example, lethality and immobility) of a test material added to dilution water, but not to food, on certain species of freshwater and saltwater fishes, macroinvertebrates, and amphibians, usually during 2 to 4-day exposures, depending on the species. These procedures will probably be useful for conducting acute toxicity tests with many other aquatic species, although modifications might be necessary.
1.2 Other modifications of these procedures might be justified by special needs or circumstances such as meeting specific study goals, regulatory needs, or to accommodate specific test organism life stages. Although using appropriate procedures is more important than following prescribed procedures, results of tests conducted using unusual or novel procedures are not likely to be comparable to results of many other tests. Comparison of results obtained using modified and unmodified versions of these procedures might provide useful information concerning new concepts and procedures for conducting acute tests.
1.3 This guide describes tests using three basic exposure techniques: static, renewal, and flow-through. Selection of the technique to use in a specific situation will depend on the needs of the investigator and on available resources. Tests using the static technique provide the most easily obtained measure of acute toxicity, but conditions often change substantially during static tests; therefore, static tests should not last longer than 96 h, and test organisms should not be fed during such tests unless the test organisms are severely stressed without feeding over 48 h. Static tests should probably not be conducted on materials that have a high oxygen demand, are highly volatile, are rapidly transformed biologically or chemically in aqueous solution, or are removed from test solutions in substantial quantities by the test chambers or organisms during the test. Because the pH and concentrations of dissolved oxygen and test material are maintained at desired levels and degradation and metabolic products are removed, tests using ren...
- Guide23 pagesEnglish languagesale 15% off
This document specifies requirements and gives guidance to suppliers and users of ancillary materials (AMs) to improve the consistency and quality of AMs of biological (human and animal) and chemical origin used in the production of cellular therapeutic products and gene therapy products for human use. This document is applicable to materials that are used for cell processing and that come into contact with the active substance and that do not intentionally form part of the final cell and gene therapy product. EXAMPLE 1 Reagents, anticoagulants, cytokines, growth factors, enzymes, antibodies, serum (human or bovine), buffered solutions, culture media, dishes (coated with biological material), beads (coated with biological material), cryoprotectants (agents for cryopreservation), activation agents/reagents, non-mammalian cell (e.g. insect cell, bacterial cell), plasmid, viral vector. This document does not apply to materials that are not used for cell processing, materials that do not come into contact with the active substance, or materials that intentionally form part of the final cell and gene therapy product. EXAMPLE 2 Cells that are either starting materials, intermediates or final form of a cellular therapeutic product, feeder cells, additives used post bioprocessing, scaffolds, non-biological consumables (e.g. beads, dishes, tissue culture flasks, bags, tubing, pipettes, needles), other plasticware that come into contact with the cell or tissue, apparatus, instruments. A decision flowchart is given in Annex A. NOTE International, regional or national regulations or requirements can also apply to specific topics covered in this document.
- Standard32 pagesEnglish languagesale 15% off
This document specifies requirements for the consistent formatting and documentation of data and corresponding metadata (i.e. data describing the data and its context) in the life sciences, including biotechnology, and biomedical, as well as non-human biological research and development. It provides guidance on rendering data in the life sciences findable, accessible, interoperable and reusable (F-A-I-R). This document is applicable to manual or computational workflows that systematically capture, record or integrate data and corresponding metadata in the life sciences for other purposes. This document provides formatting requirements for both primary experimental or procedural data obtained manually and machine derived data. This document also describes requirements for storing, sharing, accessing, interoperability and reuse of data and corresponding metadata in the life sciences. This document specifies requirements for large quantities of data systematically obtained from automated high throughput workflows in the life sciences, as well as requirements for large-scale and small-scale data sets obtained by other life science technologies and manual data capture. This document is applicable to many domains in biotechnology and the life sciences including, but not limited to: basic/applied research in all domains of the life sciences, and industrial, medical, agricultural, or environmental biotechnology (excluding for diagnostic or therapeutic purposes), as well as methodology-driven domains, such as genomics (including massive parallel sequencing, metagenomics, epigenomics and functional genomics), transcriptomics, translatomics, proteomics, metabolomics, lipidomics, glycomics, enzymology, immunochemistry, synthetic biology, systems biology, systems medicine and related fields.
- Standard54 pagesEnglish languagesale 15% off
SCOPE
1.1 This terminology is a repository for the terms, and their standardized definitions, as relates to the technical standards generated by Committee E62 on Industrial Biotechnology and Synthetic Biology. The meanings and explanations of the technical terms have been written for both the nonexpert and the expert user.
1.2 At a minimum, this terminology is updated annually (at a time corresponding to the publication of the Annual Book of ASTM Standards containing this terminology standard) to include editorially any terms approved in the committee’s technical standards.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Standard3 pagesEnglish languagesale 15% off
- Standard3 pagesEnglish languagesale 15% off
1.1 This document outlines dosimetric procedures to be followed for the radiation-induced reproductive sterilization of live insects for use in pest management programs. The primary use of such insects is in the Sterile Insect Technique, where large numbers of reproductively sterile insects are released into the field to mate with and thus control pest populations of the same species. A secondary use of sterile insects is as benign hosts for rearing insect parasitoids. A third use is for testing detection traps for fruit flies and moths, and testing mating disruption products for moths. The procedures outlined in this document will help ensure that insects processed with ionizing radiation from gamma, electron, or X-ray sources receive absorbed doses within a predetermined range. Information on effective dose ranges for specific applications of insect sterilization, or on methodology for determining effective dose ranges, is not within the scope of this document. NOTE 1—Dosimetry is only one component of a total quality assurance program to ensure that irradiated insects are adequately sterilized and fully competitive or otherwise suitable for their intended purpose. 1.2 This document provides information on dosimetry for the irradiation of insects for these types of irradiators: selfcontained dry-storage 137Cs or 60Co irradiators, self-contained low-energy X-ray irradiators (maximum processing energies from 150 keV to 300 keV), large-scale gamma irradiators, and electron accelerators (electron and X-ray modes). NOTE 2—Additional, detailed information on dosimetric procedures to be followed in installation qualification, operational qualification, performance qualification, and routine product processing can be found in ISO/ASTM Practices 51608 (X-ray [bremsstrahlung] facilities processing at energies over 300 keV), 51649 (electron beam facilities), 51702 (large-scale gamma facilities), and 52116 (self-contained dry-storage gamma facilities), and in Ref (1)2 (self-contained X-ray facilities). 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard except for the non-SI units of minute (min) hour (h) and day (d). These non-SI units are accepted for use within the SI system. 1.4 This document is one of a set of standards that provides recommendations for properly implementing and utilizing radiation processing. It is intended to be read in conjunction with ISO/ASTM Practice 52628. 1.5 The absorbed dose for insect sterilization is typically within the range of 20 Gy to 600 Gy. 1.6 This document refers, throughout the text, specifically to reproductive sterilization of insects. It is equally applicable to radiation sterilization of invertebrates from other taxa (for example, Acarina, Gastropoda) and to irradiation of live insects or other invertebrates for other purposes (for example, inducing mutations), provided the absorbed dose is within the range specified in 1.5. 1.7 This document also covers the use of radiation-sensitive indicators for the visual and qualitative indication that the insects have been irradiated (see ISO/ASTM Guide 51539). 1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.9 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Standard12 pagesEnglish languagesale 15% off
This document specifies requirements for the biobanking of human and mouse pluripotent stem cells (PSCs), including the collection of biological source material and associated data, establishment, expansion, characterization, quality control (QC), maintenance, preservation, storage, thawing, disposal, distribution and transport. This document is applicable to all organizations performing biobanking with human and mouse PSCs used for research and development. This document does not apply to cell lines used for in vivo application in humans, clinical applications or therapeutic use. NOTE International, national or regional regulations or requirements, or multiple of them, can also apply to specific topics covered in this document.
- Standard28 pagesEnglish languagesale 15% off
This document specifies requirements for the biobanking of human mesenchymal stromal cells derived from bone marrow (hBM-MSCs), including the collection of bone marrow and associated data, isolation, culture, characterization, quality control, cryopreservation, storage, thawing, disposal, distribution and transport. This document is applicable to all organizations performing biobanking with hBM-MSCs used for research. This document does not apply to hBM-MSCs for the purpose of in vivo application in humans, cell therapy, clinical applications, tissue engineering or therapeutic use. NOTE International, national or regional regulations or requirements, or multiple of them, can also apply to specific topics covered in this document.
- Standard27 pagesEnglish languagesale 15% off
This document specifies requirements for the biobanking of bacteria and archaea. It includes management of microbial material associated data as well as biosafety and biosecurity requirements. This document is applicable to all organizations performing biobanking with bacteria and archaea used for research and development. This document does not apply to processing methods for microbial materials intended for food/feed production, laboratories undertaking food/feed analysis or therapeutic use. NOTE International, national or regional regulations or requirements, or multiple of them, can also apply to specific topics covered in this document.
- Standard18 pagesEnglish languagesale 15% off
- Standard1 pageEnglish languagesale 15% off
This document specifies requirements for the biobanking of human mesenchymal stromal cells derived from umbilical cord tissue (i.e. Wharton’s jelly), further referred to as hUC-MSCs, including the collection of umbilical cord tissue and associated data, isolation, culture characterization, quality control, cryopreservation, storage, thawing, disposal, distribution and transport. This document is applicable to all organizations performing biobanking of hUC-MSCs used for research and development. This document does not apply to hUC-MSCs for the purpose of in vivo application in humans, clinical applications or therapeutic use. NOTE International, national or regional regulations or requirements, or multiple of them, can also apply to specific topics covered in this document.
- Technical specification35 pagesEnglish languagesale 15% off
This document describes prototypes of the image search engine (ISE). It focuses on the use and value of ISE, but also describes its design principles.
- Technical report9 pagesEnglish languagesale 15% off
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