Category Archives: Medical equipment in general

BS EN ISO 11197:2004 – Medical supply units

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

Number of pages – 50 pages, A4

Manufacturer – BSI

Price – GBP 150

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Keywords – Electrical medical equipment, Medical equipment, Fluids handling equipment (medical), Gas supply, Electric power systems, Safety measures, Equipment safety, Design, Marking, Instructions for use, Electrical safety, Impact testing, Classification systems, Fire safety, Earthing, Pipework systems, Leak tests, Pipe connections, Colour codes, Mechanical testing, Performance testing, Testing conditions, Electromagnetic compatibility
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BS EN 60601-1:2006 – Medical electrical equipment. General requirements for basic safety and essential performance

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

Number of pages – 384 pages, A4

Manufacturer – BSI

Price – GBP 280

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Keywords – Medical equipment, Electrical medical equipment, Safety measures, Electrical safety, Performance, Hazards, Protected electrical equipment, Radiation hazards, Fire risks, Type testing, Electrical testing, Environmental testing, Environment (working), Circuits, Classification systems, Marking, Symbols, Testing conditions, Instructions for use, Electrical insulation, Earthing, Leakage currents, Impact testing, Drop tests, Flexible conductors, Leakage paths, Clearance distances, Heating tests, Penet
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PD IEC TR 62296:2003 – Considerations of unaddressed safety aspects in the Second Edition of IEC 60601-1 and proposals for new requirements

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

Number of pages – 70 pages, A4

Manufacturer – BSI

Price – GBP 160

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Keywords – Safety measures, Electrical medical equipment, Electrical safety, Hazards, Protected electrical equipment, Radiation hazards, Fire risks, Electrical protection equipment, Type testing, Electrical testing, Environmental testing, Environment (working), Test equipment
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BS EN 60601-1-6:2004 – Medical electrical equipment. General requirements for safety. Collateral standard. Usability

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

Number of pages – 78 pages, A4

Manufacturer – BSI

Price – GBP 170

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Keywords – Electrical medical equipment, Medical equipment, Electrical equipment, Electronic equipment and components, Equipment safety, Electrical safety, Risk assessment, Ergonomics, Design
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BS EN ISO 389-8:2004 – Acoustics. Reference zero for the calibration of audiometric equipment. Reference equivalent threshold sound pressure levels for pure tones and circumaural earphones

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 – Hearing (auditory perception), Audiometry, Calibration
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BS EN ISO 14155-2:2003 – Clinical investigation of medical devices for human subjects. Clinical investigation plans

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 testing, People, Clinical investigation instruments, Diagnosis (medical), Reproducibility
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BS EN 62304:2006 – Medical device software. Software life-cycle processes

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

Number of pages – 80 pages, A4

Manufacturer – BSI

Price – GBP 170

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Keywords – Electrical medical equipment, Electrical equipment, Medical equipment, Computer software, Life (durability), Design, Maintenance, Equipment safety, Safety measures, Hazards, Software engineering techniques, Computer technology, Quality management, Risk assessment, Identification methods, Quality assurance systems
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BS EN 62353:2008 – Medical electrical equipment. Recurrent test and test after repair of medical electrical equipment

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

Number of pages – 56 pages, A4

Manufacturer – BSI

Price – GBP 160

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Keywords – Electrical medical equipment, Electrical equipment, Medical equipment, Inspection, Installation, Commissioning, Maintenance, Repair, Life (durability), Electrical safety, Safety measures, Visual inspection (testing), Electrical measurement, Leakage currents, Electrical testing, Electrical insulation
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BS EN 62366:2008 – Medical devices. Application of usability engineering to medical devices

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

Number of pages – 104 pages, A4

Manufacturer – BSI

Price – GBP 180

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Keywords – Medical equipment, Medical instruments, Medical technology, Ergonomics, Design, Equipment safety, Hazards, Instructions for use
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BS EN 60601-1-9:2008 – Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Requirements for environmentally conscious design

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

Number of pages – 34 pages, A4

Manufacturer – BSI

Price – GBP 130

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Keywords – Electrical medical equipment, Electrical equipment, Medical equipment, Safety, Environmental engineering, Design, Product design, Energy conservation, Efficiency, Life (durability), Recycling, Packaging, Pollution control, Dangerous materials, Wastes, Noise (environmental), Type testing
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BS EN 61558-2-15:2001 – Safety of power transformers, power supply units and similar. Particular requirements for isolating transformers for the supply of medical locations

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

Number of pages – 20 pages, A4

Manufacturer – BSI

Price – GBP 114

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Keywords – Power transformers, Small-power transformers, Transformers, Electrical safety, Electric power systems, Electrical equipment, Isolating transformers, Electrical medical equipment, Equipment safety
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BS EN 60601-1-2:2002, IEC 60601-1-2:2002 – Medical electrical equipment. General requirements for safety. Collateral standard. Electromagnetic compatibility. Requirements and tests

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

Number of pages – 106 pages, A4

Manufacturer – BSI

Price – GBP 180

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Keywords – Medical equipment, Electrical medical equipment, Electrical equipment, Electronic equipment and components, Electrical safety, Electromagnetic radiation, Safety measures, Noise (spurious signals), Radio disturbances, Electromagnetic compatibility
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BS EN ISO 14971:2007 – Medical devices. Application of risk management to medical devices

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

Number of pages – 94 pages, A4

Manufacturer – BSI

Price – GBP 154

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Keywords – Medical equipment, Medical instruments, Risk assessment, Risk analysis, Management, Hazards, Clinical investigation instruments, Safety measures, Diagnosis (medical)
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BS EN ISO 14155-1:2003 – Clinical investigation of medical devices for human subjects. General requirements

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

Number of pages – 34 pages, A4

Manufacturer – BSI

Price – GBP 130

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Keywords – Medical equipment, Clinical testing, People, Performance, Performance testing, Equipment safety, Risk assessment, Documents
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BS EN ISO 389-7:2005 – Acoustics. Reference zero for the calibration of audiometric equipment. Reference threshold of hearing under free-field and diffuse-field listening conditions

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 – Audiometers, Hearing (auditory perception), Auditory threshold, Audiometry, Audiology, Calibration, Acoustic measurement, Acoustoelectric devices, Acoustic equipment, Audiofrequencies, Testing conditions, Test equipment, Sound intensity, Control samples, Thresholds
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BS EN 13718-1:2008 – Medical vehicles and their equipment. Air ambulances. Requirements for medical devices used in air ambulances

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 – Ambulances, Air transport, Aircraft, Patient transport equipment, Emergency vehicles, Ambulance services, Medical equipment, Medical instruments, Interfaces, Performance, Environment (working)
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BS EN 13718-2:2008 – Medical vehicles and their equipment. Air ambulances. Operational and technical requirements of air ambulances

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

Number of pages – 34 pages, A4

Manufacturer – BSI

Price – GBP 130

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Keywords – Ambulances, Air transport, Aircraft, Patient transport equipment, Emergency vehicles, Ambulance services, Helicopters, Fixed-wing aircraft, Aircraft components, Environment (working), Medical equipment, Gas pipelines, Emergency equipment, Medical breathing apparatus, Personnel
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PD ISO/TR 16142:2006 – Medical devices. Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices

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

Number of pages – 26 pages, A4

Manufacturer – BSI

Price – GBP 114

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Keywords – Medical equipment, Medical technology, Electrical medical equipment, Equipment safety, Safety measures, Performance, Selection, Standards, Acceptance (approval)
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BS EN 60601-1-8:2007 – Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard. General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

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

Number of pages – 82 pages, A4

Manufacturer – BSI

Price – GBP 154

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Keywords – Medical equipment, Electrical medical equipment, Electrical equipment, Electronic equipment and components, Hospital equipment, Warning devices, Signals, Acoustic signals, Visual signals, Indicator lights, Flashing lights, Alarm systems, Legibility, Grades (quality), Colour, Harmonics, Sound intensity, Frequencies
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BS EN 60601-1:1990, BS 5724-1:1989 – Medical electrical equipment. General requirements for safety

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

Number of pages – 200 pages, A4

Manufacturer – BSI

Price – GBP 216

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Keywords – Medical equipment, Safety measures, Electrical medical equipment, Electrical safety, Hazards, Protected electrical equipment, Radiation hazards, Fire risks, Electrical protection equipment, Type testing, Electrical testing, Environmental testing, Environment (working), Test equipment, Circuits, Classification systems, Marking, Symbols, Testing conditions, Instructions for use, Electrical insulation, Earthing, Leakage currents, Impact testing, Mechanical testing, Drop tests, Flexible conductors,
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BS 5724-1:1979 – Medical electrical equipment. Specification for general safety requirements

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

Number of pages – 220 pages, A4

Manufacturer – BSI

Price – GBP 180

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Keywords – Medical equipment, Safety measures, Electrical medical equipment, Electrical safety, Marking, Symbols, Protected electrical equipment, Explosions, Radiation hazards, Fire risks, Electrical protection equipment, Type testing, Electric shocks
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PD 6573:1994, IEC TR 60513:1994 – Fundamental aspects of safety standards for medical electrical equipment

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

Number of pages – 68 pages, A4

Manufacturer – BSI

Price – GBP 150

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Keywords – Electrical medical equipment, Medical equipment, Safety measures, Standards, Specifications, Electrical safety, Hazards, Occupational safety, Safety engineering, Safety, Defects, Patients, Radiation hazards, Electrical faults, Equipment safety, Classification systems, Design, Operators (personnel), Consumer-supplier relations, Quality assurance, Electrical insulation, Earthing, Leakage currents, Legislation, Accidents, Document maintenance, Performance, Safety devices, Marking, Signs, Clinical t
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DC94/506771 – BS EN 1441. Medical devices. Risk analysis (draft prEN 1441)

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

Number of pages –

Manufacturer – BSI

Price – GBP 13

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Keywords – Medical equipment in general
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BS EN ISO 389-4:1999 – Acoustics. Reference zero for the calibration of audiometric equipment. Reference levels for narrow-band masking noise

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 – Audiometry, Acoustic measurement, Bandwidths, Frequencies, Audiofrequencies, Hearing (auditory perception), Auditory threshold, Acoustic signals, Audibility
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BS EN 60601-1-1:2001 – Medical electrical equipment. General requirements for safety. Collateral standard. Safety requirements for medical electrical systems. Section 1.1 Collateral standard: Safety requirements for medical electrical systems

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

Number of pages – 34 pages, A4

Manufacturer – BSI

Price – GBP 130

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Keywords – Medical equipment, Electrical medical equipment, Electrical equipment, Electronic equipment and components, Risk assessment, Health and safety requirements, Safety measures, Safety devices
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BS EN ISO 389-3:1999 – Acoustics. Reference zero for the calibration of audiometric equipment. Reference equivalent threshold force levels for pure tones and bone vibrators

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 – Audiometers, Acoustic equipment, Calibration, Audiometry, Ears, Datum, Hearing (auditory perception), Bones, Auditory threshold, Acoustoelectric devices, Acoustic measurement
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BS ISO 17166:1999 – Erythema reference action spectrum and standard erythema dose

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 – Dermatology, Skin (body), Radiation, Ultraviolet radiation, Dose limits, Spectral emittance, Spectroscopy
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BS EN ISO 389-1:2000 – Acoustics. Reference zero for the calibration of audiometric equipment. Reference equivalent threshold sound pressure levels for pure tones and supra-aural earphones

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 – Acoustics, Acoustic engineering, Reference conditions, Calibration, Measuring instruments, Acoustic equipment, Audiometry, Sound intensity, Single, Frequencies, Earphones, Hearing (auditory perception), Auditory threshold, Airborne noise, Acoustic measurement, Couplers, Artificial ears
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BS EN 60601-1-4:1997, BS 5724-1.4:1997,IEC 60601-1-4:1996 – Medical electrical equipment. General requirements for safety. Collateral standard. General requirements for programmable electrical medical systems

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 equipment, Electrical medical equipment, Electrical equipment, Electronic equipment and components, Computerized control, Hazards, Occupational safety, Electrical safety
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BS EN 60601-1-2:2007 – Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests

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

Number of pages – 128 pages, A4

Manufacturer – BSI

Price – GBP 176

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Keywords – Medical equipment, Electrical medical equipment, Electrical equipment, Electronic equipment and components, Electrical safety, Electromagnetic radiation, Safety measures, Noise (spurious signals), Radio disturbances, Electromagnetic compatibility, Performance, Performance testing
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BS EN 60601-1-8:2004 – Medical electrical equipment. General requirements for safety. Collateral standard. General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

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

Number of pages – 76 pages, A4

Manufacturer – BSI

Price – GBP 170

CLICK HERE FOR MORE INFORMATION

Keywords – Medical equipment, Electrical medical equipment, Electrical equipment, Electronic equipment and components, Hospital equipment, Warning devices, Signals, Acoustic signals, Visual signals, Indicator lights, Flashing lights, Alarm systems, Legibility, Grades (quality), Colour, Harmonics, Sound intensity, Frequencies
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BS EN 60601-1-6:2007 – Medical electrical equipment. General requirements for basic safety and essential Performance. Collateral standard. Usability

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

Number of pages – 78 pages, A4

Manufacturer – BSI

Price – GBP 170

CLICK HERE FOR MORE INFORMATION

Keywords – Electrical medical equipment, Medical equipment, Electrical equipment, Electronic equipment and components, Equipment safety, Electrical safety, Risk assessment, Ergonomics, Design
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BS EN ISO 389-2:1997 – Acoustics. Reference zero for the calibration of audiometric equipment. Reference equivalent threshold sound pressure levels for pure tones and insert earphones

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

Number of pages – 20 pages, A4

Manufacturer – BSI

Price – GBP 80

CLICK HERE FOR MORE INFORMATION

Keywords – Acoustics, Audiometers, Auditory threshold, Calibration, Datum, Earphones, Sound intensity, Horizontal, Measurement
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