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Proposed standard (1)

ReferenceTitle
ISO/TC 276 N 236Inventory of biotechnology-related termsComment deadline: 10/3/2016

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Standards in development (73)

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Standard TitleStatus
BS EN 868-2 Packaging for terminally sterilized medical devices Part 2: Sterilization wrap - Requirements and test methodsApproval
BS EN 868-3 Packaging for terminally sterilized medical devices Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methodsApproval
BS EN 868-4 Packaging for terminally sterilized medical devices Part 4: Paper bags - Requirements and test methodsApproval
BS EN 868-6 Packaging for terminally sterilized medical devices Part 6: Paper for low temperature sterilization processes - Requirements and test methodsApproval
BS EN 868-7 Packaging for terminally sterilized medical devices Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methodsApproval
BS EN ISO 11138-6 Sterilization of health care products - Biological Indicators Part 6: Biological indicators for hydrogen peroxide vapour sterilization processes (ISO/NP 11138-6:2008)Accepted
Opens a new windowBS ENISO 11133:2014/Amd 1 Microbiology of food, animal feed and water - Preparation, production, storage and performance testing of culture media - Amendment 1Public Comment
BS ENISO 10272-1 Horizontal method for detection and enumeration of Campylobacter Part 1: Detection methodPublic Comment
BS ENISO 10272-2 Horizontal method for detection and enumeration of Campylobacter Part 2: Colony-count techniquePublic Comment
BS ENISO 10273 Microbiology of the food chain - Horizontal method for the detection of pathogenic Yersinia enterocoliticaPublic Comment
BS ENISO 11137-3 Sterilization of health care products - Radiation Part 3: Guidance on dosimetric aspectsPublic Comment
BS ENISO 11138-1 Biological indicators Part 1: General requirementsApproval
BS ENISO 11138-2 Biological indicators Part 2: Biological indicators for ethylene oxide sterilization processesApproval
BS ENISO 11138-3 Biological indicators Part 3: Biological indicators for moist heat sterilization processesApproval
BS ENISO 11138-4 Biological indicators Part 4: Biological indicators for dry heat sterilization processesTechnical Review
BS ENISO 11138-4 Sterilization of health care products - Biological indicators Part 4: Biological indicators for dry heat sterilization processesApproval
BS ENISO 11138-5 Biological indicators Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processesApproval
BS ENISO 11140-6 Sterilization of health care products – Chemical indicators – Part 6: Class 2 indicators and process challenge devices for use in performance testing for small steam sterilizers (remark: publication as EN ISO 11140-6 (VA), replacement of EN 867-5:200Accepted
Opens a new windowBS ENISO 11737-1 Sterilization of medical devices - Microbiological methods Part 1: Determination of a population of microorganisms on productsPublic Comment
BS ENISO 11737-2 Sterilization of medical devices - Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization processIdea
BS ENISO 13408-2 Aseptic processing of health care products Part 2: FiltrationAccepted
BS ENISO 14161 Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of resultsAccepted
BS ENISO 15216-1 Microbiology of the food chain - Horizontal method for determination of hepatitis A virus and norovirus in food using real-time RT-PCR Part 1: Method for quantificationPublic Comment
BS ENISO 15883-1 Washer-disinfectors Part 1: General requirements, terms and definitions and testsIdea
BS ENISO 15883-4 Washer-disinfectors Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopesPublic Comment
BS ENISO 15883-5 Washer disinfectors Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacyIdea
BS ENISO 16140-3 Microbiology of the food chain - Method validation Part 3: Protocol for the verification of reference and alternative methods implemented in a single laboratoryAccepted
BS ENISO 16140-4 Microbiology of the food chain - Method validation Part 4: Protocol for in-house (single) laboratory method validationAccepted
BS ENISO 16140-5 Microbiology of the food chain Method validation Part 5: Protocol for factorial interlaboratory method validationIdea
BS ENISO 16140-6 Microbiology of the food chain Method validation Part 6: Protocol for the validation of microbiological confirmation methodsAccepted
BS ENISO 16654:2001 Amd 1/Amd 1 animal feeding stuffs - Horizontal method for the detection of Escherichia coli O157 - Amendment 1Public Comment
BS ENISO 17664 Information to be provided by the device manufacturer for the processing of reusable medical devicesPublic Comment
BS ENISO 17665-1 Sterilization of health care products - Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devicesIdea
BS ENISO 18465 Horizontal method for the quantification of Bacillus cereus emetic toxin (Cereulide) using LC-MS/MSApproval
BS ENISO 18472 Biological and chemical indicators - Test equipmentAccepted
BS ENISO 18593 Horizontal methods for sampling techniques from surfaces using contact plates and swabsPublic Comment
Opens a new windowBS ENISO 19020 Horizontal method for the detection of staphylococcal enterotoxins in foodPublic Comment
BS ENISO 19343 Detection and quantification of histamine by HPLC methodPublic Comment
Opens a new windowBS ENISO 20976-1 Microbiology of the food chain - Guidelines for conducting challenge tests of food and feed products Part 1: Challenge tests to study the growth potential, lag time and the maximum growth ratePublic Comment
BS ENISO 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 techniquePublic Comment
BS ENISO 21528-2 Horizontal methods for the detection and enumeration of Enterobacteriaceae Part 2: Colony-count methodPublic Comment
BS ENISO 21872 stuffs - Detection of species of vibrio parahaemolyticus - Vibrio cholerae and vibrio vulnificusPublic Comment
BS ENISO 22964 Horizontal method for the detection of Cronobacter spp.Public Comment
BS ENISO 6579-1 Horizontal method for the detection, enumeration and serotyping of Salmonella Part 1: Detection methodPublication
BS ENISO 6887-1 Preparation of test samples, initial suspension and decimal dilutions for microbiological examination Part 1: General rules for the preparation of the initial suspension and decimal dilutionsApproval
BS ENISO 6887-2 Preparation of test samples, initial suspension and decimal dilutions for microbiological examination Part 2: Specific rules for the preparation of meat and meat productsApproval
BS ENISO 6887-3 Preparation of test samples, initial suspension and decimal dilutions for microbiological examination Part 3: Specific rules for the preparation of fish and fishery productsApproval
BS ENISO 6887-4 Preparation of test samples, initial suspension and decimal dilutions for microbiological examination Part 4: Specific rules for the preparation of products other than milk and milk products, meat and meat products, and fish and fishery productsApproval
BS ISO 20391-1 Biotechnology - Cell Counting Part 1: General guidance on cell counting methodsAccepted
BS ISO 20391-2 Biotechnology - Cell Counting Part 2: Experimental design and statistical analysis to quantify counting method performanceAccepted
BS ISO 11133:2014/Amd 1 Microbiology of food, animal feed and water - Preparation, production, storage and performance testing of culture media - Amendment 1Accepted
BS ISO 11135:2014/Amd 1 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1Accepted
BS ISO 13722 Microbiology of the food chain - Enumeration of Brochothrix spp. - Colony-count techniquePublic Comment
BS ISO 15216-2 Microbiology of the food chain - Horizontal method for determination of hepatitis A virus and norovirus in food using real-time RT-PCR - Part 2: Method for qualitative detectionnull
BS ISO 16342 Sterilization of health care products - Method for validation of a biological indicator incubation periodAccepted
BS ISO 16649-1 Microbiology of the food chain - Horizontal method for the enumeration of beta-glucuronidase-positive Escherichia coli Part 1: Colony-count technique at 44 degrees C using membranes and 5-bromo-4-chloro-3-indolyl beta-D-glucuronideAccepted
BS ISO 17410 Microbiology of food and animal feeding stuffs - Horizontal method for the enumeration of psychrotrophic microorganismsAccepted
BS ISO 17997 Milk - Determination of casein-nitrogen content - Reference methodAccepted
BS ISO 19660 Cream - Determination of fat content - Acido-butyrometric method (Routine Method)Public Comment
BS ISO 19662 Milk - Determination of fat content - Acido-butyrometric Method (Gerber method)Public Comment
BS ISO 20395 Quality considerations for targeted nucleic acid quantification methodsIdea
BS ISO 25424 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devicesAccepted
BS ISO 6888-1:1999/Amd 2 Microbiology of food and animal feeding stuffs - Horizontal method for the enumeration of coagulase-positive staphylococci (Staphylococcus aureus and other species) Part 1: Technique using Baird-Parker agar medium - Amendment 2: Confirmation test using RPFA stab methodAccepted
BS ISO 6888-3 Microbiology of the food chain - Horizontal method for the enumeration of coagulase-positive staphylococci (Staphylococcus aureus and other species) Part 3: Detection and MPN technique for low numbersAccepted
BS ISO/TS 19046-1 acid by chromatography Part 1: Reference methodApproval
BS ISO/TS 19046-2 acid by chromatography Part 2: Routine methodApproval
PD EN ISO 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 ENISO 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 11139 Sterilization of health care products - VocabularyAccepted
PD ISO/TS 20399-1 Raw materials control for bioprocessing Part 1: General definitions and requirements for quality controlIdea
PD ISO/TS 20399-2 Raw materials control for bioprocessing Part 2: Best practice guide for suppliesIdea
PD ISO/TS 20399-3 Raw materials control for bioprocessing Part 3: Best practice guide for developersIdea
PD ISO/TS 19930 Guidance on aspects of a risk-based approach to assuring sterility of terminally-sterilized, single-use health care productsAccepted

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Published standards (24)

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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 13312-5:2001Biotechnology. Performance criteria for piping and instrumentation - ValvesCurrent
BS EN 13312-6:2001Biotechnology. Performance criteria for piping and instrumentation - Equipment probesCurrent
BS EN 13312-4:2001Biotechnology. Performance criteria for piping and instrumentation - Tubes and pipesCurrent
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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