Category Archives: In vitro diagnostic test systems

BS EN 12286:1999 – In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Presentation of reference measurement procedures

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 16 pages, A4

Manufacturer – BSI

Price – GBP 80

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Keywords – Medical equipment, Medical instruments, Clinical investigation instruments, Diagnosis (medical), Biological analysis and testing, Measurement, Samples, Documents, Layout, Safety measures, Terminology, Calibration, Data processing, Statistical methods of analysis, Reliability, Precision, Accuracy, Reproducibility, Quality assurance
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BS EN 591:2001 – Instructions for use for in vitro diagnostic instruments for professional use

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 14 pages, A4

Manufacturer – BSI

Price – GBP 64

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Keywords – Diagnosis (medical), Clinical investigation instruments, Medical sciences, Instructions for use
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BS EN 375:2001 – Information supplied by the manufacturer with in vitro diagnostic reagents for professional use

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 18 pages, A4

Manufacturer – BSI

Price – GBP 80

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Keywords – Diagnosis (medical), Clinical investigation instruments, Reagent solutions, Instructions for use, Reagent bottles, Containers, Medical equipment
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BS EN 14136:2004 – Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 14 pages, A4

Manufacturer – BSI

Price – GBP 64

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Keywords – Diagnostic programs, Diagnosis (medical), Assessed quality
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BS EN 376:2002 – Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 18 pages, A4

Manufacturer – BSI

Price – GBP 80

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Keywords – Medical equipment, Medical instruments, Diagnosis (medical), Clinical investigation instruments, Reagent solutions, Chemical reagents, Instructions for use
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BS EN 592:2002 – Instructions for use for in vitro diagnostic instruments for self-testing

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 14 pages, A4

Manufacturer – BSI

Price – GBP 64

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Keywords – Medical instruments, Medical equipment, Clinical investigation instruments, Diagnosis (medical), Instructions for use
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BS EN 13532:2002 – General requirements for in vitro diagnostic medical devices for self-testing

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 12 pages, A4

Manufacturer – BSI

Price – GBP 64

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Keywords – Medical equipment, Diagnostic testing, Clinical investigation instruments, Diagnosis (medical), Personal health, Health and safety requirements
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BS EN 13975:2003 – Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 16 pages, A4

Manufacturer – BSI

Price – GBP 80

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Keywords – Sampling methods, Approval testing, Acceptance (approval), Clinical investigation instruments, Statistics, Statistical methods of analysis, Medical equipment, Diagnosis (medical), Process control, Homogeneity, Certification (approval), Quality assurance
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BS EN ISO 17511:2003 – In vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of values assigned to calibrators and control materials

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 32 pages, A4

Manufacturer – BSI

Price – GBP 114

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Keywords – Medical instruments, Clinical investigation instruments, Measurement, Control samples
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BS EN ISO 18153:2003 – In vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 20 pages, A4

Manufacturer – BSI

Price – GBP 80

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Keywords – Medical instruments, Clinical investigation instruments, Measurement, Control samples
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BS EN ISO 15197:2003 – In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 46 pages, A4

Manufacturer – BSI

Price – GBP 150

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Keywords – Clinical investigation instruments, Glucose, Blood, Measurement
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BS EN 14254:2004 – In vitro diagnostic medical devices. Single-use receptacles for the collection of specimens, other than blood, from humans

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 22 pages, A4

Manufacturer – BSI

Price – GBP 80

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Keywords – Clinical investigation instruments, Clinical laboratory equipment, Medical equipment, Disposable, Containers, Medical specimens, Patients, Diagnosis (medical), Medical inspection, Performance testing
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BS ISO 15198:2004 – Clinical laboratory medicine. In vitro diagnostic medical devices. Validation of user quality control procedures by the manufacturer

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 18 pages, A4

Manufacturer – BSI

Price – GBP 80

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Keywords – Medical equipment, Clinical laboratory equipment, Clinical investigation instruments, Medical instruments, Quality control, Verification
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BS ISO 17593:2007 – Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 64 pages, A4

Manufacturer – BSI

Price – GBP 142

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Keywords – Diagnosis (medical), Blood, Anticoagulants, Blood coagulation, Patients, Clinical investigation instruments, Medical equipment, Clinical testing, Clinical medicine, Laboratory testing, Performance, Quality assurance, Training, Verification, Performance testing
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BS EN 61326-2-6:2006 – Electrical equipment for measurement, control and laboratory use. EMC requirements. Particular requirements. In vitro diagnostic (IVD) medical equipment

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 14 pages, A4

Manufacturer – BSI

Price – GBP 64

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Keywords – Electrical equipment, Measuring instruments, Electrical measuring instruments, Electric control equipment, Laboratory equipment, Electromagnetic compatibility, Electromagnetic radiation, Electromagnetic fields, Electromagnetism, Type testing, Performance, Testing conditions, Medical equipment
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06/30154803 DC – EN ISO 15193. In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for content and presentation of reference measurement procedures

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 28 pages, A4

Manufacturer – BSI

Price – GBP 20

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Keywords – Medical equipment, Electrical medical equipment, Samples, Testing
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BS EN 13640:2002 – Stability testing of in vitro diagnostic reagents

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 14 pages, A4

Manufacturer – BSI

Price – GBP 64

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Keywords – Diagnosis (medical), Chemical reagents, Stability testing, Stability, Storage, Life (durability), Verification, Medical equipment
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BS EN 13641:2002 – Elimination or reduction of risk of infection related to in vitro diagnostic reagents

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 12 pages, A4

Manufacturer – BSI

Price – GBP 64

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Keywords – Biotechnology, Biochemical methods of analysis, Chemical analysis and testing, Diagnosis (medical), Medical sciences, Biological hazards
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BS EN 13612:2002 – Performance evaluation of in vitro diagnostic medical devices

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 18 pages, A4

Manufacturer – CEN

Price – GBP 80

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Keywords – Medical equipment, Performance testing, Clinical investigation instruments, Diagnosis (medical), Patients, Diagnostic testing
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BS EN 12287:1999 – In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Description of reference materials

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 16 pages, A4

Manufacturer – BSI

Price – GBP 80

CLICK HERE FOR MORE INFORMATION

Keywords – Diagnosis (medical), Biological analysis and testing, Count methods (microbiology), Microbiological analysis, Medical specimens, Test specimens, Control samples, Calibration, Classification systems, Terminology, Identification methods, Components, Reports, Chemical properties, Experimental design, Safety measures, Instructions for use, Marking, Certificates of conformity
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BS EN 12376:1999 – In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 14 pages, A4

Manufacturer – BSI

Price – GBP 64

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Keywords – Medical equipment, Medical laboratory equipment, Biological stains, Dyes, Chemical reagents, Diagnosis (medical), Biological analysis and testing, Natural product chemistry, Marking, Instructions for use, Reproducibility, Bibliography
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BS EN 1658:1997 – Requirements for marking of in vitro diagnostic instruments

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 10 pages, A4

Manufacturer – BSI

Price – GBP 64

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Keywords – Clinical investigation instruments, Clinical laboratory equipment, Medical laboratory equipment, Diagnosis (medical), Marking, Identification methods, Electrical safety, Electrical medical equipment
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