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.

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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.

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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.

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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.

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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).

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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.

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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.

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This document specifies the procedure for the determination 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 also applicable to the blends of fertilizing products where plant biostimulants are the main part of the blend. Otherwise, the Technical Specification for the main part of the blend apply.

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This document specifies the methods to be used for the determination of quantity of solid and liquid forms of Plant biostimulants in packages, containers or in bulk.
This document is not applicable to the quantity determination of: Soil improvers, growing media, organic and organo-mineral fertilizers and fertilizing product blends whose main constituent is a growing media or soil improver. The method for quantity determination for these products is given in EN 15761, EN 15238 and EN 12580.

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This document was developed to provide a method for verifying that hexavalent chromium (CrVI) is not present in plant biostimulants in a concentration that exceeds the respective limits outlined in the EU Regulation on Fertilising Products [1].
This document is applicable to all types of plant biostimulants (solid and liquid ) used in agriculture.
The method described is suitable to quantify the chromium(VI) content in plant biostimulants down to 2 mg/kg.
The results obtained from this method are strictly dependent on the extraction conditions. Results obtained by using other extraction procedures (extraction solution, pH, extraction time, etc.) are not comparable with the results produced by the procedure described in this document.

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This document specifies a method for determination of the content of mercury (Hg) in plant biostimulants using (cold) vapour generation apparatus coupled to an atomic absorption spectrophotometer and a method using a direct amalgamation technique. It is applicable to aqua regia digests prepared according to CEN/TS 17701-1.
NOTE    It is also possible to use other suitable methods for the determination of mercury described in Annex A if users prove that the method gives the same results as the methods described in this document.
This document is also applicable to the blends of fertilizing products where plant biostimulants are the main part of the blend. Otherwise, the Technical Specification for the main part of the blend applies.

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This document specifies a method for extraction, separation, and determination of inorganic arsenic (iAs) in plant biostimulants using anion-exchange HPLC or IC coupled to ICP-MS.
This document is also applicable to the blends of fertilizing products where plant biostimulants are the main part of the blend. Otherwise, the Technical Specification for the main part of the blend apply.

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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 also applicable to the blends of fertilizing products where plant biostimulants are the main part of the blend. Otherwise, the Technical Specification for the main part of the blend apply.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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This document describes prototypes of a database for developing biomimetic products with innovative problem-solving methods (TRIZ). The database has a mechanism to obtain the idea of technical problem-solving using the problem- and function-oriented approaches. This document focuses on the use and value of the database, but also describes its design principles.

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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.

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This document specifies the procedure for the determination 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 also applicable to the blends of fertilizing products where plant biostimulants are the main part of the blend. Otherwise, the Technical Specification for the main part of the blend applies.

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This document specifies a method for determination of the content of mercury (Hg) in plant biostimulants using (cold) vapour generation apparatus coupled to an atomic absorption spectrophotometer and a method using a direct amalgamation technique. It is applicable to aqua regia digests prepared according to CEN/TS 17701-1.
NOTE    It is also possible to use other suitable methods for the determination of mercury described in Annex A if users prove that the method gives the same results as the methods described in this document.
This document is also applicable to the blends of fertilizing products where plant biostimulants are the main part of the blend. Otherwise, the Technical Specification for the main part of the blend applies.

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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 also applicable to the blends of fertilizing products where plant biostimulants are the main part of the blend. Otherwise, the Technical Specification for the main part of the blend applies.

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This document was developed to provide a method for verifying that hexavalent chromium (CrVI) is not present in plant biostimulants in a concentration that exceeds the respective limits outlined in the EU Regulation on Fertilising Products [1].
This document is applicable to all types of plant biostimulants (solid and liquid ) used in agriculture.
The method described is suitable to quantify the chromium(VI) content in plant biostimulants down to 2 mg/kg.
The results obtained from this method are strictly dependent on the extraction conditions. Results obtained by using other extraction procedures (extraction solution, pH, extraction time, etc.) are not comparable with the results produced by the procedure described in this document.

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This document specifies a method for extraction, separation, and determination of inorganic arsenic (iAs) in plant biostimulants using anion-exchange high performance liquid chromatography (HPLC) or ion chromatography (IC) coupled to ICP-MS.
This document is also applicable to the blends of fertilizing products where plant biostimulants are the main part of the blend. Otherwise, the Technical Specification for the main part of the blend applies.

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This document specifies the methods to be used for the determination of quantity of solid and liquid forms of plant biostimulants in packages, containers or in bulk.
This document is not applicable to the quantity determination of: soil improvers, growing media, organic and organo-mineral fertilizers and fertilizing product blends whose main constituent is a growing media or soil improver. The method for quantity determination for these products is given in EN 15761, EN 15238 and EN 12580.

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This document specifies the general requirements for and gives guidance on quality assessments of nucleic acid samples. It specifies general guidelines for library preparations and library quality assessments prior to sequencing and data generation.

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This document provides requirements and recommendations for conducting marine surveys of interstitial biota in marine sediments. It includes the specification of technical methods for the investigation of marine sediments, foraminifera, ostracoda, radiolaria, diatoms, coccoliths, sedimentary sporopollen, benthic viruses, benthic microbes (including bacteria, archaea and fungi), benthic microalgae, benthic protozoa and metazoan meiobenthos. This document is applicable to marine surveys in diverse benthic habitats at any seabed, such as benthic sediments of coastal zones, shallow seas, or deep-sea waters.

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This document specifies requirements for the collection, reception, preparation, preservation, transport, storage, distribution, destruction and disposal of biological materials obtained from animals, excluding humans. Such resources include solid tissues, fluid samples and associated cells, excretory products and associated data. This document is applicable to biological material or associated data, or both, that can be used for research and development and to biomolecules derived from the biological material, e.g. nucleic acids, proteins and metabolites. This document is applicable to all organizations performing biobanking for research and development. This document does not apply to biological material intended for food or feed production, laboratories undertaking analysis for food or feed production, or therapeutic use, or multiple of them. This document does not apply to the establishment of cell lines derived from animal biological material. NOTE International, national or regional regulations or requirements, or multiple of them, can also apply to specific topics covered in this document.

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This document defines terms related to genome editing technology. This document is applicable to general use of genome editing across species.

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This document specifies requirements for the collection, preparation, preservation, transportation, storage, distribution and disposal of plant biological materials and associated data. This document is applicable only to biological material that can be used for further processing of biomolecules, e.g. nucleic acids, proteins and metabolites. This document is applicable to all organizations performing plant biobanking for research and development.

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This document specifies minimum requirements and general considerations for equipment, consisting of hardware, software and consumables, used in the manufacturing of cells for therapeutic use. This includes equipment for processing cells for therapeutic use starting from cell isolation/selection, expansion, washing and volume reduction, from cell finish through to cryopreservation for the storage of cells for therapeutic use. This document gives guidance on the design, use and maintenance of equipment and equipment systems to both suppliers and users from aspects including the target parties, i.e. supplier or user, and phase of involved task, i.e. design, use or maintenance. This document is applicable to any unit operation system that is used, alone or in combination, for the manufacturing of cells for therapeutic use, meeting user requirements. It is applicable to devices used for the purpose of monitoring equipment status. It does not apply to: processing equipment for cells for therapeutic use used at the point of care; devices used for analytical purposes; biosafety cabinets, general cell culture equipment (such as CO2 incubators, etc.), and software to control multiple equipment systems or multiple unit operations.

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This document provides general requirements for the testing of cellular therapeutic products intended for human use. This document also provides considerations for the characterization of cellular therapeutic products, including approaches to select and design analytical methods that are fit for purpose. Such considerations can be used to establish critical quality attributes for a cellular therapeutic product. This document is applicable to cellular starting materials (including those for tissue engineered products) and intermediates of cellular therapeutic products. This document is not applicable to tissues used in transplantation.

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  • Standard
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    35 pages
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This document reviews best practices that: a) respect the existing standardization efforts of life sciences research communities; b) normalize key aspects of data description particularly at the level of the biology being studied (and shared) across the life sciences communities; c) ensure that data are “findable” and useable by other researchers; and d) provide guidance and metrics for assessing the applicability of a particular data sharing plan. This document is applicable to domains in life sciences including biotechnology, genomics (including massively parallel nucleotide sequencing, metagenomics, epigenomics and functional genomics), transcriptomics, translatomics, proteomics, metabolomics, lipidomics, glycomics, enzymology, immunochemistry, life science imaging, synthetic biology, systems biology, systems medicine and related fields.

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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, organizations and schemes using peer-assessment, accreditation bodies, and others can also use this document in confirming or recognizing the competence of biobanks.
This document does not apply to biological material intended for food/feed production, laboratories undertaking analysis for food/feed production, and/or therapeutic use.
NOTE 1    International, national or regional regulations or requirements can also apply to specific topics covered in this document.
NOTE 2    For entities handling human materials procured and used for diagnostic and treatment purposes ISO 15189 and other clinical standards are intended to apply first and foremost.

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This document specifies general requirements and recommendations for quality assessments and control of massively parallel sequencing (MPS) data. It covers post raw data generation procedures, sequencing alignments, and variant calling. This document also gives general guidelines for validation and documentation of MPS data. This document does not apply to any processes related to de novo assembly.

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    21 pages
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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, organizations and schemes using peer-assessment and accreditation bodies. This document does not apply to biological material intended for therapeutic use. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

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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 MRCs, regulatory authorities, organizations, and schemes using peer-assessment to confirm or recognize the competence of MRCs in data management and publication NOTE International, national and/or regional regulations or requirements can also apply to specific topics covered in this document.

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    25 pages
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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, organizations and schemes using peer-assessment, accreditation bodies, and others can also use this document in confirming or recognizing the competence of biobanks.
This document does not apply to biological material intended for food/feed production, laboratories undertaking analysis for food/feed production, and/or therapeutic use.
NOTE 1 International, national or regional regulations or requirements can also apply to specific topics covered in this document.
NOTE 2 For entities handling human materials procured and used for diagnostic and treatment purposes ISO 15189 and other clinical standards are intended to apply first and foremost.

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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 plan including verification and validation, communication between the client and the transportation service provider, and associated documentation. This document does not specify particular conditions for transportation such as specification for shipping container, ambient temperature control, etc.

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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 biological material intended for food/feed production, laboratories undertaking food/feed analysis, and/or therapeutic use. Reference material production is not covered in this document. For the production requirements for reference materials, see ISO 17034.

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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 organizations performing biobanking, including biobanking of biological material from multicellular organisms (e.g., human, animal, fungus and plant) and microorganisms for research and development. This document does not apply to biological material intended for feed/food production, laboratories undertaking analysis for food/feed production and/or therapeutic use.

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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.

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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.

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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 measurement processes, provided that the measurement process meets the criteria of the experimental design (e.g. cells are suspended in a solution). This method is most suitable during cell counting method development, optimization, validation, evaluation and/or verification of cell counting measurement processes. This method is especially applicable in cases where an appropriate reference material to assess accuracy is not readily available. This method does not directly provide the accuracy of the cell count. This method is primarily applicable to eukaryotic cells. NOTE Several sector/application specific international and national standards for cell counting exist. Where applicable, consulting existing standards when operating within their scope can be helpful.

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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 (dsDNA) such as genomic DNA (gDNA) and plasmid DNA, single stranded DNA (ssDNA), complementary DNA (cDNA), and single stranded RNA (ssRNA) including ribosomal RNA (rRNA), messenger RNA (mRNA), and long and short non-coding RNA [microRNAs (miRNAs) and short interfering RNAs (siRNAs)], as well as double-stranded RNA (dsRNA). This document applies to nucleic acids derived from biological sources such as viruses, prokaryotic and eukaryotic cells, cell-free biological fluids (e.g. plasma or cell media) or in vitro sources [e.g. oligonucleotides, synthetic gene constructs and in vitro transcribed (IVT) RNA]. This document is not applicable to quantification of very short DNA oligonucleotides ( This document covers: — analytical design including quantification strategies (nucleic acid copy number quantification using a calibration curve as in qPCR or through molecular counting as in dPCR, quantification relative to an independent sample and ratio measurements) and use of controls; — quantification of total nucleic acid mass concentration and quality control of a nucleic acid sample including assessment of nucleic acid quality (purity and integrity); — PCR assay design, optimization, in silico and in vitro specificity testing; — data quality control and analysis including acceptance criteria, threshold setting and normalization; — method validation (precision, linearity, limit of quantification, limit of detection, trueness and robustness) with specific requirements for qPCR and dPCR; — approaches to establishing metrological traceability and estimating measurement uncertainty. This document does not provide requirements or acceptance criteria for the sampling of biological materials or processing of biological samples (i.e. collection, preservation, transportation, storage, treatment and nucleic acid extraction). Nor does it provide requirements and acceptance criteria for specific applications (e.g. food or clinical applications where specific matrix issues can arise).

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