90/220/EEC - Deliberate release into the environment of genetically modified organisms

This document gives requirements and recommendations for installation, commissioning and routine testing of BSC.

This document specifies the minimum requirements for BSC with respect to design, construction, safety and hygiene and gives general test methods for their verification.
The requirements for the different classes are given in the respective parts of EN 12469.

This document specifies the specific requirements for class II BSC with respect to design, construction, safety and hygiene.
It sets the specific performance criteria for class II BSC for work with biological agents and specifies test procedures with respect to protection of the worker, the environment and product protection including cross-contamination.

This document gives requirements and recommendations for installation, commissioning and routine testing of BSC.

This document specifies the minimum requirements for BSC with respect to design, construction, safety and hygiene and gives general test methods for their verification.
The requirements for the different classes are given in the respective parts of prEN 12469.

This document specifies the specific requirements for class II BSC with respect to design, construction, safety and hygiene.
It sets the specific performance criteria for class II BSC for work with biological agents and specifies test procedures with respect to protection of the worker, the environment and product protection including cross-contamination.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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)).

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.

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)).

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.

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...

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.

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...

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.

This European Standard gives 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 genetically modified plants. Monitoring encompasses detection of genes and traits, as well as the identification of genetically modified plants in an experimental release. This European Standard provides the person conducting a monitoring programme with factors and criteria that should be considered in determining the validity of the proposed monitoring strategy.

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.

This European Standard describes the principles for the assessment and selection of fermentation and downstream operations so that they are carried out in a manner which ensures the safety of personnel and the environment and quality and safety of the product. It is intended for use by those designing and/or operating processes, by regulatory bodies and auditors, and by other interested parties. Unit operations are not described in detail and individual production processes can require specific equipment or unit operations which are not described here.

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.

This European Standard specifies design requirements for plant buildings used for the safe handling of microorganisms and the product itself if it presents a biohazard. Note 1: When applying this European Standard, attention is drawn to the existing national regulations such as regulations concerning genetic engineering, water and environmental emission concerning the design requirements.

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.

This European Standard gives guidance for setting up a valid sampling strategy to meet the objectives of a monitoring strategy for genetically modified plants. The sampling is to provide material to which subsequent analytical methods for monitoring genetically modified plants of interest can be applied. This European Standard deals only with providing statistically valid samples from the experimental field as identified in a field trial design.

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.

This European Standard gives guidance on the assessment and the selection of procedures for treatment of waste process microorganisms from biotechnological plant to ensure the safety of people and environment. This European Standard applies to wastes and effluents (solid, liquid and gaseous) emitted from biotechnological processes which include traditional processes such as brewing or food processing, fermentation of pharmaceutical and chemical products as well as biotechnological processes for environmental and agricultural application.

This European Standard gives guidance on the selection and risk analysis of biotechnological equipment and the subsequent assembly of these into a plant in order to attain the appropriate biosafety containment levels. This includes verification of installation, operation and maintenance. It also applies when a new process or significant changes are introduced into an existing plant.