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Standards in development (51)

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Standard TitleStatus
BS EN 556-2 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE'' Part 2: Requirements for aseptically processed medical devicesIdea
BS EN ISO 12779 Lactose - Determination of water content - Karl Fischer methodApproval
Opens a new windowBS EN ISO 16140-2 Microbiology of food and animal feeding stuffs - Method validation Part 2: Protocol for the validation of Alternative (proprietary) methods against a reference methodPublic Comment
BS EN ISO 16649-3 Microbiology of food and animal feeding stuffs - Horizontal method for the enumeration of beta-glucuronidase-positive Escherichia coli Part 3: Detection and most probable number technique using 5-bromo-4-chloro-3-indolyl-beta-D-glucuronidePublic Comment
BS EN ISO 17468 Microbiology of food and animal feeding stuffs - Technical requirements and guidance on establishment or revision of standard methodsPublic Comment
BS EN ISO 4833-1 Microbiology of food and animal feed — Horizontal method for the enumeration of microorganisms — Part 1: Colony count at 30 °C by the pour plate techniqueApproval
BS EN ISO 7218:2007/A1 Microbiology of food and animal feeding stuffs - General requirements and guidance for microbiological examinationsApproval
BS EN ISO 8968-1 Milk and milk products - Determination of nitrogen content Part 1: Determination of nitrogen content and crude protein calculation (Kjeldahl principle)Public Comment
BS EN ISO 8968-3:2007/COR 1 Milk - Determination of nitrogen content Part 3: Block-digestion method (Semi-micro rapid routine method)Accepted
BS EN ISO 8968-4:2002/COR 1 Milk - Determination of nitrogen content Part 4: Determination of non-protein-nitrogen contentAccepted
BS EN ISO 9233-1 Cheese, cheese rind and processed cheese - Determination of natamycin content Part 1: Molecular absorption spectrometric method for cheese rindApproval
BS EN ISO 9233-2 Cheese, cheese rind and processed cheese - Determination of natamycin content Part 2: High performance liquid chromatographic method for cheese, cheese rind and processed cheeseApproval
BS ENISO 11133 Microbiology of food, animal feeding stuffs and water - Preparation, production, storage and performance testing of culture mediaPublic Comment
BS ENISO 11135 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devicesPublic Comment
BS ENISO 11137-1:2006/A1 Sterilization of health care products - Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1Approval
BS ENISO 11137-2 Sterilization of health care products - Radiation Part 2: Establishing the sterilization doseApproval
BS ENISO 11137-3 Sterilization of health care products - Radiation Part 3: Guidance on dosimetric aspectsAccepted
BS ENISO 11607-1:2009/A1 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems - Amendment 1Public Comment
BS ENISO 11607-2:2006/A1 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes - Amendment 1Public Comment
BS ENISO 13408-1:2011/A1 A Aseptic processing of health care products Part 1: General requirementsPublication
BS ENISO 13408-6/A1 A Aseptic processing of health care products Part 6: Isolator systemsPublication
Opens a new windowBS ENISO 16140-1 Microbiology of food and animal feeding stuffs - Method validation Part 1: Terminology of method validationPublic Comment
BS ENISO 18743 Detection of Trichinella Larvae in meat - Physical method by digestionPublic Comment
BS ENISO 4833-2 Microbiology of food and animal feed — Horizontal method for the enumeration of microorganisms — Part 2: Colony count at 30°C by the surface plating techniqueApproval
BS ENISO 5536 Milk fat products - Determination of water content - Karl Fischer methodApproval
BS ISO 10272-1 Microbiology of food and animal feed - Horizontal method for detection and enumeration of Campylobacter Part 1: Detection methodIdea
BS ISO 11140-6 Sterilization of health care products - Chemical indicators Part 6: Class 2 indicators and process challenge devices for use in perf ormance testing for steam sterilizersIdea
BS ISO 11816-1 Milk and milk products - Determination of alkaline phosphatase activity Part 1: Fluorimetric method for milk and milk-based drinksApproval
BS ISO 11816-2 Milk and milk products - Determination of alkaline phosphatase activity Part 2: Fluorometric method for cheeseAccepted
BS ISO 16297 Milk - Bacterial count - Protocol for the evaluation of alternative methodsPublication
BS ISO 16775 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2Accepted
BS ISO 16958 Milk products and infant formulae - Direct determination of labelled fatty acids content - Capillary gas chromatographic methodAccepted
BS ISO 17604 Microbiology of food and animal feeding stuffs - Carcass sampling for microbiological analysisAccepted
BS ISO 17664 Sterilization of medical devices - Information to be provided by the device manufacturer for the processing of reusable medical devicesAccepted
BS ISO 17758 Instant dried milk — Determination of the dispersibility and wettabilityPublic Comment
BS ISO 17997 Milk - Determination of casein-nitrogen content - Reference methodAccepted
BS ISO 18362 Processing of cell-based health care productsIdea
BS ISO 18744 Microbiology of food and animal feed - Detection and enumeration of Cryptosporidium and Giardia in fresh leafy green vegetables and berry fruitsIdea
BS ISO 21528-1 Microbiology of food and animal feeding stuffs - Horizontal methods for the detection and enumeration of Enterobacteriaceae Part 1: Detection and enumeration by MPN techniqueAccepted
BS ISO 8968-4 Milk and milk products - Determination of nitrogen content Part 4: Determination of protein nitrogen content and true protein calculationAccepted
BS ISO 9622 Milk and liquid milk products - Guidance on the application of mid-infrared spectrometryApproval
BS ISO/TS 18083 Processed cheese products - Calculation of content of added phosphate expressed as phosphorusAccepted
PD CEN ISO/TS 15216-1 Microbiology of food and animal feeding stuffs - Horizontal method for detection of hepatitis A virus and norovirus in food using real-time RT-PCR Part 1: Method for quantitative determinationPublication
PD CEN ISO/TS 15216-2 Microbiology of food and animal feeding stuffs - Horizontal method for detection of hepatitis A virus and norovirus in food using real-time RT-PCR Part 2: Method for qualitative detectionPublication
PD CEN ISO/TS 17728 Microbiology of food and animal feed - Sampling techniques for microbiological analysis of food and feed samplesApproval
PD CEN ISO/TS 17919 Microbiology of food and animal feed - Polymerase chain reaction (PCR) for the detection of food-borne pathogens - Detection of botulinum neurotoxin type A, B, E and F - producing clostridiaApproval
PD ISO/TR 6579-3 Microbiology of food and animal feed - Horizontal method for the detection, enumeration and serotyping of Salmonella Part 3: Guidance for serotypingAccepted
PD ISO/TS 11290-1 Microbiology of food and animal feed - Horizontal method for the detection and enumeration of Listeria monocytogenes and other Listeria species Part 1: Detection methodAccepted
PD ISO/TS 11290-2 Microbiology of food and animal feed - Horizontal method for the detection and enumeration of Listeria monocytogenes and other Listeria species Part 2: Enumeration methodAccepted
PD ISO/TS 13305 Microbiology of food, animal feeding stuffs, animal faeces and environmental samples from the primary production stage - Horizontal method for the enumeration of Salmonella by a miniaturized MPN techniqueAccepted
PD ISO/TS 17665-3 Sterilization of health care products - Steam sterilization Part 3: Product familiesApproval

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Published standards (24)

Sort by: Reference | Title | Status

Standard referenceNameStatus
BS EN 12296:1998Biotechnology. Equipment. Guidance on testing procedures for cleanabilityCurrent
BS EN 12298:1998Biotechnology. Equipment. Guidance on testing procedures for leaktightnessCurrent
BS EN 12297:1998Biotechnology. Equipment. Guidance on testing procedures for sterilizabilityCurrent
BS EN 12689:1998Biotechnology. Guidance on assessment of the purity, biological activity and stability of micro-organism based productsCurrent
BS EN 13092:2000Biotechnology. Guidance on sampling and inoculation proceduresCurrent
BS EN 12128:1998Biotechnology. Laboratories for research, development and analysis. Containment levels of microbiology laboratories, areas of risk, localities and physical safety requirementsCurrent
BS EN 12741:1999Biotechnology. Laboratories for research, development and analysis. Guidance for biotechnology laboratory operationsCurrent
BS EN 12738:1999Biotechnology. Laboratories for research, development and analysis. Guidance for containment of animals inoculated with microorganisms in experimentsCurrent
BS EN 12740:1999Biotechnology. Laboratories for research, development and analysis. Guidance for handling, inactivating and testing of wasteCurrent
PD 6632:1998Biotechnology. Laboratories for research, development and analysis. Guidance on the selection of equipment needed for biotechnology laboratories according to the degree of hazardCurrent
BS EN 12685:1998Biotechnology. Modified organisms for application in the environment. Guidance for the monitoring strategies for deliberate release of genetically modified micro-organisms, including virusesCurrent
BS EN 12686:1998Biotechnology. Modified organisms for application in the environment. Guidance for the sampling strategies for deliberate releases of genetically modified micro-organisms, including virusesCurrent
BS EN 13091:2000Biotechnology. Performance criteria for filter elements and filtration assembliesCurrent
BS EN 12469:2000Biotechnology. Performance criteria for microbiological safety cabinetsCurrent
BS EN 13095:2000Biotechnology. Performance criteria for off-gas systemsCurrent
BS EN 13312-1:2001Biotechnology. Performance criteria for piping and instrumentation - General performance criteriaCurrent
BS EN 13312-2:2001Biotechnology. Performance criteria for piping and instrumentation - CouplingsCurrent
BS EN 13312-3:2001Biotechnology. Performance criteria for piping and instrumentation - Sampling and inoculation devicesCurrent
BS EN 13312-4:2001Biotechnology. Performance criteria for piping and instrumentation - Tubes and pipesCurrent
BS EN 13312-5:2001Biotechnology. Performance criteria for piping and instrumentation - ValvesCurrent
BS EN 13312-6:2001Biotechnology. Performance criteria for piping and instrumentation - Equipment probesCurrent
BS EN 12462:1998Biotechnology. Performance criteria for pumpsCurrent
BS EN 12690:1999Biotechnology. Performance criteria for shaft sealsCurrent
BS 5763-16:1995Methods for microbiological examination of food and animal feeding stuffs - Detection of presumptive pathogenic Yersinia enterocoliticaWithdrawn

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