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 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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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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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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  • Technical report
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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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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 requirements can also apply to specific topics covered in this document.

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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. However, diverse biological sources, including plants, insects and marine organisms, can also be used in the development of a cellular therapeutic product. Therefore the fundamental principles of risk management also apply for these sources of AMs. This document does not cover the selection, assessment or control of starting materials and excipients. However, it is anticipated that these are still covered by general risk management procedures. This document is applicable for users at all stages of clinical development and supply; however maximum benefits can be gained by the implementation of the recommendations in the early stages of development. NOTE 2 International, regional or national regulations or requirements can also apply to specific topics covered in this document.

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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, media (including media additives), growth factors, and monoclonal antibodies] and chemical origin. This document does not address dimethyl sulfoxide (DMSO) for cryopreservation, beads, scaffolds, feeder cells, apparatus and instruments, or additives used post bioprocessing. This document does not cover the selection, assessment or control of starting materials and excipients. 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 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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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 cell types ? mammalian and non-mammalian (e.g. bacteria, yeast) cells. ISO 20391-1:2018 is not intended for counting of cells while in a tissue section or a biomaterial matrix. Several sector/application-specific international and national standards for cell counting currently exist. When applicable, the user can consult existing standards when operating within their scope (specific measurement techniques and/or applications).

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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 abstractions. The transfer process from biology to technology is described based on examples of biomimetic materials, structures, surfaces, components, and manufacturing technologies. This International Standard describes measurement methods and parameters for the characterization of properties of biomimetic materials. This International Standard provides information on the relevance of biomimetic materials, structures, surfaces, components, and manufacturing technologies for industry. ISO 18457:2016 also links to other subareas in biomimetics because fundamental developments in materials, structures, surfaces, components, and manufacturing technologies often form the basis for a wide variety of additional innovations. It provides guidance and support for all those who develop, design, process, or use biomimetic materials, structures, surfaces, components, and manufacturing technologies. This International Standard can also serve for those who want to learn about and investigate these topics.

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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 normally forages over an area of up to 5 km radius (median 1,6 km, mean 2,2 km), in rare cases some bees may also forage in greater distances up to 10 km and more [26].
Foragers fix the gathered pollen on the outside of their hind legs (pollen loads, also known as pollen pellets). Inside the hive they place these pollen loads into comb cells close to the brood nest (bee bread). Furthermore, foragers gather nectar and honeydew. Nectar contains pollen which fell from the anthers of the blossom into the nectar drop, or pollen which was dispersed by the wind and sticks in the nectar of other blossoms or adheres to the sticky honeydew of plants. Nectar and honeydew are converted to honey and stored by the bees in the beehive.
Honey, pollen load and bee-bread may be used as sample matrices for the subsequent analysis of pollen as it is possible to concentrate sufficient amounts of pollen for microscopic and molecular biological diagnostics.
Microscopic analysis is used to identify the various pollen types and to quantify the exposure to the target pollen types in question. GMO exposure is analyzed by molecular-biological methods: For analysis of pollen DNA quantitative PCR methods are used and described here in this Technical Specification. The analysis of GMO specific proteins and toxins in pollen is possible, too, using ELISA, but to this date the method has not been evaluated enough in pollen matrices for standardization in this Technical Specification.

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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 amounts of pollen to additionally carry out molecular-biological diagnostics for detection of GMO.
Essential background information on performing GMO monitoring is given in Guideline VDI 4330 Part 1 [4], which is based on an integrated assessment of temporal and spatial variation of GMO cultivation (sources of GMO), the exposure in the environment and biological/ecological effects. Ideally, the pollen sampling using technical samplers for GMO monitoring should be undertaken in combination with the biological collection of pollen by bees (FprCEN/TS 16817-2).
The application of technical passive samplers and the use of honey bee colonies as active biological collectors complement each other in a manifold way when monitoring the exposure to GMO pollen. Technical samplers provide results regarding the pollen input at the sampling site in a representative way, whereas with biological sampling by honey bee colonies, pollen from flowering plants in the area is collected according to the bees' collection activity. Thus, this method represents GMO exposure to roaming insects. By combining the two sampling methods these two main principles of exposure are represented. Furthermore, a broad range of pollen species is covered.
The sample design depends on the intended measuring objective. Some examples are given in 6.2.

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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 as a sustainability strategy are also illustrated. In addition, ISO 18458:2015 provides an overview of the various areas of application and describes how biomimetic methods differ from classic forms of research and development. If a technical system is subjected to a development process according to ISO 18458:2015, then it is allowed to be referred to as a "biomimetic" system. ISO 18458:2015 provides guidance and support for developers, designers, and users who want to learn about the biomimetic development process and integrate biomimetic methods into their work aiming at a common language for scientists and engineers working in the field of biomimetics. It can be applied wherever nature has produced a biological system sufficiently similar to the technical target system that can be used to develop a technical equivalent.

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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. ISO 18459:2015 is intended primarily for designers, developers, engineers, and technicians, but also for all persons entrusted with the design and evaluation of load-bearing structures.

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ISO/ASTM 51940:2013 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. The procedures outlined in this guide 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 guide. 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.

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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 European Standard gives biological, physical and procedural containment measures for work with genetically modified plants including plants where the transferred genetic material is derived from a non-plant source. It defines measures to minimize hazards identified by risk analysis.
Containment may be provided in a greenhouse or in a growthroom, laboratory or other containment facility.
Containment of genetically modified microorganisms and/or small animals associated with plants is not included in this standard. Containment of microorganisms in laboratories is covered in EN 12128.

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This European Standard specifies performance criteria for equipment probes used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of the equipment probes includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

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This European Standard specifies performance criteria for sampling and inoculation devices used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of the sampling and inoculation device includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

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This European Standard specifies performance criteria for glass pressure vessels used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of glass pressure vessels includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

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This European Standard specifies performance criteria for vessels used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of the equipment includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

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This European Standard specifies performance criteria for valves used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of the valve includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

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This European Standard specifies performance criteria for bioreactors used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of bioreactors includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

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This European Standard specifies performance criteria for pressure protection devices used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of pressure protection devices includes hazardous or potentially hazardous microorganisms used in biotechnological processes.

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This European Standard specifies performance criteria for couplings used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of the coupling includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

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This European Standard specifies performance criteria for piping and instrumentation used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of the equipment includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

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This European Standard specifies performance criteria for chromatography columns used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of chromatography columns includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

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This European Standard specifies performance criteria for kill tanks used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of kill tanks includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

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This European Standard specifies performance criteria for tubes and pipes used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use. This European Standard applies where the intended use of the tubes and pipes includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

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This European Standard gives biological, physical and procedural containment measures for work with genetically modified plants including plants where the transferred genetic material is derived from a non-plant source. It defines measures to minimize hazards identified by risk analysis.
Containment may be provided in a greenhouse or in a growthroom, laboratory or other containment facility.
Containment of genetically modified microorganisms and/or small animals associated with plants is not included in this standard. Containment of microorganisms in laboratories is covered in EN 12128.

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This European Standard specifies performance criteria for glass pressure vessels used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of glass pressure vessels includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

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This European Standard specifies performance criteria for pressure protection devices used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of pressure protection devices includes hazardous or potentially hazardous microorganisms used in biotechnological processes.

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This European Standard specifies performance criteria for bioreactors used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of bioreactors includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

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This European Standard specifies performance criteria for vessels used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of the equipment includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

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This European Standard specifies performance criteria for chromatography columns used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of chromatography columns includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

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This European Standard specifies performance criteria for kill tanks used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of kill tanks includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

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This European Standard specifies performance criteria for couplings used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of the coupling includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

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This European Standard specifies performance criteria for piping and instrumentation used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of the equipment includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

  • Standard
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This European Standard specifies performance criteria for sampling and inoculation devices used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of the sampling and inoculation device includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

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This European Standard specifies performance criteria for equipment probes used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of the equipment probes includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

  • Standard
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