This document defines a process to identify, assess, control, and monitor the risks associated with hazardous biological materials. This document is applicable to any laboratory or other organization that works with, stores, transports, and/or disposes of hazardous biological materials. This document is intended to complement existing International Standards for laboratories. This document is not intended for laboratories that test for the presence of microorganisms and/or toxins in food or feedstuffs. This document is not intended for the management of risks from the use of genetically modified crops in agriculture.

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This document specifies methods for determining the deterioration of plastics due to the action of fungi and bacteria and soil microorganisms. The aim is not to determine the biodegradability of plastics or the deterioration of natural fibre composites.
The type and extent of deterioration can be determined by
a) visual examination and/or
b) changes in mass and/or
c) changes in other physical properties.
The tests are applicable to all plastics that have an even surface and that can thus be easily cleaned. The exceptions are porous materials, such as plastic foams.
This document uses the same test fungi as IEC 60068-2-10. The IEC method, which uses so-called "assembled specimens", calls for inoculation of the specimens with a spore suspension, incubation of the inoculated specimens and assessment of the fungal growth as well as any physical attack on the specimens.
The volume of testing and the test strains used depend on the application envisaged for the plastic.

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ISO 21528-2:2017 specifies a method for the enumeration of Enterobacteriaceae. It is applicable to - products intended for human consumption and the feeding of animals, and - environmental samples in the area of primary production, food production and food handling. This technique is intended to be used when the number of colonies sought is expected to be more than 100 per millilitre or per gram of the test sample. The most probable number (MPN) technique, as included in ISO 21528‑1, is generally used when the number sought is expected to be below 100 per millilitre or per gram of test sample.

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  • Standard
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ISO 21528-1:2017 specifies a method, with enrichment, for the detection of Enterobacteriaceae. It is applicable to - products intended for human consumption and the feeding of animals, and - environmental samples in the area of primary production, food production and food handling. This method is applicable - when the microorganisms sought are expected to need resuscitation by enrichment, and - when the number sought is expected to be below 100 per millilitre or per gram of test sample. A limitation on the applicability of ISO 21528-1:2017 is imposed by the susceptibility of the method to a large degree of variability (see Clause 11). NOTE Enumeration can be carried out by calculation of the most probable number (MPN) after incubation in liquid medium. See Annex A.

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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 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 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 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 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 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 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 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.

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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 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 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 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 basic requirements for microbiological safety cabinets (MSCs) with respect to safety and hygiene. This European Standard sets the minimum performance criteria for safety cabinets for work with microorganisms and specifies test procedures for microbiological safety cabinets with respect to protection of the worker and the environment, product protection and cross contamination. Mechanical, electrical, chemical or radioactive safety precautions are not covered in the standard but are covered in EN 610101-1, EN 292-1 and EN 292-2 (see Bibliography (1), (2) and (3)).

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This European Standard specifies basic requirements for microbiological safety cabinets (MSCs) with respect to safety and hygiene. This European Standard sets the minimum performance criteria for safety cabinets for work with microorganisms and specifies test procedures for microbiological safety cabinets with respect to protection of the worker and the environment, product protection and cross contamination. Mechanical, electrical, chemical or radioactive safety precautions are not covered in the standard but are covered in EN 610101-1, EN 292-1 and EN 292-2 (see Bibliography (1), (2) and (3)).

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This European Standard specifies performance criteria for filter elements and filtration assemblies used in biotechnological processes with respect to the potential risks of microorganisms in use for the worker and the environment. This European Standard applies where the intended use of the filter elements or filtration assemblies includes hazardous or potentially hazardous microorganisms used in biotechnological processes and/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 off-gas systems used in biotechnological processes with respect to the potential risks of microorganisms in use for the worker and the environment. This European Standard applies where the intended use of the off-gas system includes hazardous or potentially hazardous microorganisms used in biotechnological processes and/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 guidance to the manufacturer of sampling and inoculation devices on providing instructions in the manufacturer's documentation accompanying his products in accordance with prEN 13312-3. It has the purpose of pointing out to him, which hazards can occur during operation, s so that he can take these into account in an adequate way during construction and will be in a positive to formulate information for use giving adequate consideration of safety...

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This European Standard gives guidance on assessment of technical specifications of microorganism based products (MBPs) for product quality evaluation. It is also applicable for purposes of product registration. NOTE 1: In this European Standard, the technical specifications are considered to be purity, biological activity and stability of microorganism based product. This European Standard describes criteria and factors considered for the validity of the assessment of the technical specifications.

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This European Standard specifies performance criteria for cell disrupters used in the biotechnological processes with respect to the potential risks of microorganisms in use for the worker or the environment. This European Standard applies where the intended use of the cell disrupter includes hazardous or potentially hazardous microorganisms used in biotechnological processes and/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 provides guidance concerning the procedures for setting up a valid sampling strategy to meet the objectives of a monitoring strategy for GMMs released into the environment. Since monitoring methods of microorganisms in environmental samples usually require pretreatment of the samples, for example the extraction and isolation of GMMs and/or their nucleic acid, this is included in scope of this European Standard. The sampling is to provide material to which subsequent analytical or biological methods for monitoring of GMMs can be applied.

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This European Standard provides guidance on factors and criteria considered for the determination of the suitability and validity of the design, development and execution of a monitoring strategy for GMM. Monitoring encompasses detection of genotypic and phenotypic properties, as well as detection of viral material and/or symptoms specific for the infected host, for the identification of GMMs in an experimental release.

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This European Standard specifies minimum physical requirements for biological safety for laboratories at four reference physical containment levels which are appropriate for handling microorganisms of different risk groups. This European Standard primarily addresses the containment of microorganisms which can present a risk to human health. It applies to microbiology laboratories where the handling of microorganisms in bacteriology, mycology, virology, parasitology and/or genetic modification is carried out.

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This European Standard gives guidance on the steps that should be followed during the analysis of the genetic modification of interest: - to analyse and describe the genetic modification of interest as it exists in the GMO (genomic modification); - to detect and/or identify the GMO accurately. This European Standard gives guidance on the factors and criteria considered by the experimenter for the selection of the appropriate method(s) and the validity of experimental results for the analysis of the genetic modification of interest.

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This European Standard gives guidance on methods for handling, inactivating and testing of waste containing organisms arising from biotechnology laboratory activities and processes. It is concerned with methods to reduce the risks arising from exposure to waste derived from laboratory-scale activities which contains organisms hazardous or potentially hazardous to humans, animals, plants or the environment.

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This European Standard, in order to protect the worker and/or the environment, gives guidance on minimum physical biosafety measures for the containment of animals deliberately inoculated with microorganisms, including genetically modified microorganisms, which can present a risk to human or animal health or the environment. This European Standard does not apply to the containment of animals which have not been deliberately inoculated with microorganisms.

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This European Standard gives guidance for practice for biotechnology operations in research, development and analysis laboratories of containment levels 1, 2, 3 and 4 (see EN 12128 and prEN 12738). This European Standard aims at the protection of workers from biological hazards as well as the environment including plants and animals.

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This European Standard specifies performance criteria for cell disrupters used in the biotechnological processes with respect to the potential risks of microorganisms in use for the worker or the environment. This European Standard applies where the intended use of the cell disrupter includes hazardous or potentially hazardous microorganisms used in biotechnological processes and/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 shaft seals in equipment used in biotechnological processes with respect to the potential risks of microorganisms in use for the worker or the environment.

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This European Standard specifies performance criteria for centrifuges used in biotechnological processes with respect to the potential risks of microorganisms in use for the worker or the environment.

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This European Standard gives guidance on assessment of technical specifications of microorganism based products (MBPs) for product quality evaluation. It is also applicable for purposes of product registration. NOTE 1: In this European Standard, the technical specifications are considered to be purity, biological activity and stability of microorganism based product. This European Standard describes criteria and factors considered for the validity of the assessment of the technical specifications.

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This European Standard provides guidance concerning the procedures for setting up a valid sampling strategy to meet the objectives of a monitoring strategy for GMMs released into the environment. Since monitoring methods of microorganisms in environmental samples usually require pretreatment of the samples, for example the extraction and isolation of GMMs and/or their nucleic acid, this is included in scope of this European Standard. The sampling is to provide material to which subsequent analytical or biological methods for monitoring of GMMs can be applied.

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This European Standard provides guidance on factors and criteria considered for the determination of the suitability and validity of the design, development and execution of a monitoring strategy for GMM. Monitoring encompasses detection of genotypic and phenotypic properties, as well as detection of viral material and/or symptoms specific for the infected host, for the identification of GMMs in an experimental release.

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This European Standard specifies minimum physical requirements for biological safety for laboratories at four reference physical containment levels which are appropriate for handling microorganisms of different risk groups. This European Standard primarily addresses the containment of microorganisms which can present a risk to human health. It applies to microbiology laboratories where the handling of microorganisms in bacteriology, mycology, virology, parasitology and/or genetic modification is carried out.

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This European Standard gives guidance on general testing procedures to assess the sterilizability for microorganisms of equipment (components and units of equipment) used in biotechnological processes. This European Standard gives guidance on the assessment of the sterilizability of biotechnological equipment with respect to a release of process microorganisms that can affect the safety of the worker (occupational health) and/or that can have adverse effects to the environment.

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This European Standard gives guidance on general testing procedures to assess the cleanability of equipment (components and units of equipment) used in biotechnological processes. This European Standard applies primarily if the intended use of equipment includes the use of potentially hazardous microorganisms. This European Standard also applies to non-hazardous micro- organisms and/or to residual soil which can adversely affect sterilization processes or which can cause cross-contamination of products or processes.

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This European Standard gives guidance on general testing procedures to assess the leaktightness for microorganisms of equipment (components and units of equipment) used in biotechnological processes. This European Standard gives guidance on the assessment of the leaktightness of biotechnological equipment with respect to a release of process microorganisms that can affect the safety of the worker (occupational health) and/or that can have adverse effects to the environment.

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This CEN Report is designed to give a view of CEN Standards activity containing microbiological aspects.  It takes the form of a register of work items.  The register includes current work items and published Standards from TCs which are working on standards containing microbiological aspects.  The information in this register was produced on February 2001.
The intended audience of this Report is those people working in Standardization who have an interest in microbiological aspects.  It will be particularly useful for those people working on a subject with microbiological aspects, who wish to co-ordinate their efforts and therefore avoid duplication of work. In particular, this report is intended to assist in the evolution of common terms and definitions in standards that involve microbiological aspects.
The register is not exhaustive.  There may be other CEN TCs with microbiological aspects but these are not known at the time of writing this CEN Report.
Not all the information is available for all the work items listed.

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Migrated from Progress Sheet (TC Comment) (2000-07-10): CEN Report BT C 56/1996 (TD: 960911): Approved  BUT Letter to TC on 1996- ++ 09-25 asking him to finalize the CEN Report before publication and that ++ on the basis of comments received from Members! We request him to contact ++ therefore PTE! (T.A.) ++ Approval as CEN Report: RES BT C 56/1996 ++ SB report (AFNOR 96-09-26): Action CR: PM = RM.

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Migrated from Progress Sheet (TC Comment) (2000-07-10): SPP update 1997-10-09. Will be CR. Still in WG. ++ Approval of CEN Report (Res BT C 208/1998) (CC/981020)

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