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Medical equipment

Key standards:

StandardsDescription
BS EN ISO 14971:2019 Medical devices. Application of risk management to medical devices
BS EN ISO 5356-1:2015 Anaesthetic and respiratory equipment. Conical connectors. Cones and sockets
BS EN ISO 23747:2015 Anaesthetic and respiratory equipment. Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans
BS EN ISO 5360:2016 Anaesthetic vaporizers. Agent-specific filling systems
BS EN ISO 5364:2016 Anaesthetic and respiratory equipment. Oropharyngeal airways
BS EN ISO 5366:2016 Anaesthetic and respiratory equipment. Tracheostomy tubes and connectors
BS EN ISO 389-3:2016 Acoustics. Reference zero for the calibration of audiometric equipment. Reference equivalent threshold vibratory force levels for pure tones and bone vibrators
BS ISO 14117:2019 Active implantable medical devices. Electromagnetic compatibility. EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
PD ISO/TS 10974:2018 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
BS EN ISO 9999:2016 Assistive products for persons with disability. Classification and terminology
BS EN ISO 10993-6:2016 Biological evaluation of medical devices.  Tests for local effects after implantation
PD ISO/TR 15499:2016 Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process
BS EN ISO 5840-2:2015 Cardiovascular implants. Cardiac valve prostheses. Surgically implanted heart valve substitutes
PD ISO/TS 17137:2019 Cardiovascular implants and extracorporeal systems. Cardiovascular absorbable implants
BS EN ISO 7199:2017 Cardiovascular implants and artificial organs. Blood-gas exchangers (oxygenators)
BS ISO 15675:2016 Cardiovascular implants and artificial organs. Cardiopulmonary bypass systems. Arterial blood line filters
BS EN ISO 7439:2015 Copper-bearing contraceptive intrauterine devices. Requirements and tests
BS 5682:2015 Dimensions of probes and terminal units for medical gas supply systems. Requirements
BS EN ISO 8871-5:2016 Elastomeric parts for parenterals and for devices for pharmaceutical use
BS EN ISO 8637-2:2018 Extracorporeal systems for blood purification. Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
BS ISO 11195:2018 Gas mixers for medical use. Stand-alone gas mixers
BS EN ISO 6009:2016 Hypodermic needles for single use. Colour coding for identification
BS ISO 13779-2:2018 Implants for surgery. Hydroxyapatite. Thermally sprayed coatings of hydroxyapatite
BS ISO 13779-3:2018 Implants for surgery. Hydroxyapatite. Chemical analysis and characterization of crystallinity ratio and phase purity
BS ISO 13779-4:2018 Implants for surgery. Hydroxyapatite. Determination of coating adhesion strength
BS ISO 14242-2:2016 Implants for surgery. Wear of total hip-joint prostheses. Methods of measurement
BS ISO 5832-12:2019 Implants for surgery. Metallic materials. Wrought cobalt-chromium-molybdenum alloy
BS ISO 5832-9:2019 Implants for surgery. Metallic materials. Wrought high nitrogen stainless steel
BS ISO 5834-2:2019 Implants for surgery. Ultra-high-molecular-weight polyethylene. Moulded forms
BS ISO 5834-5:2019 Implants for surgery. Ultra-high-molecular-weight polyethylene. Morphology assessment method
BS ISO 6474-2:2019 Implants for surgery. Ceramic materials. Composite materials based on a high-purity alumina matrix with zirconia reinforcement
BS EN 45502-1:2015 Implants for surgery. Active implantable medical devices. General requirements for safety, marking and for information to be provided by the manufacturer
BS EN ISO 13356:2015 Implants for surgery. Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)
BS ISO 7206-10:2018 Implants for surgery. Partial and total hip-joint prostheses. Determination of resistance to static load of modular femoral heads
BS EN ISO 16054:2019 Implants for surgery. Minimum data sets for surgical implants
BS ISO 14243-2:2016 Implants for surgery. Wear of total knee-joint prostheses. Methods of measurement
BS ISO 6474-1:2019 Implants for surgery. Ceramic materials. Ceramic materials based on high purity alumina
BS ISO 18835:2015 Inhalational anaesthesia systems. Draw-over anaesthetic systems
BS EN ISO 8536-11:2015 Infusion equipment for medical use.  Infusion filters for single use with pressure infusion equipment
BS EN ISO 8536-8:2015 Infusion equipment for medical use. Infusion sets for single use with pressure infusion apparatus
BS EN ISO 8536-9:2015 Infusion equipment for medical use. Fluid lines for single use with pressure infusion equipment
BS EN ISO 8536-10:2015 Infusion equipment for medical use. Accessories for fluid lines for single use with pressure infusion equipment
BS EN ISO 8362-2:2015 Injection containers and accessories. Closures for injection vials
BS EN ISO 15197:2015 In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
BS EN ISO 23640:2015 In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
BS EN ISO 16061:2015 Instrumentation for use in association with non-active surgical implants. General requirements
BS EN ISO 15195:2019 Laboratory medicine. Requirements for the competence of calibration laboratories using reference measurement procedures
BS ISO 16038:2017 Male condoms. Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms
BS EN ISO 15223-1:2016 – TC Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements
BS EN 455-2:2015 Medical gloves for single use. Requirements and testing for physical properties
BS EN ISO 4074:2015 Natural rubber latex male condoms. Requirements and test methods
BS EN ISO 11608-1:2015 Needle-based injection systems for medical use. Requirements and test methods. Needle-based injection systems
PD IEC TR 61948-4:2019 Nuclear medicine instrumentation. Routine tests. Radionuclide calibrators
PD IEC/TR 61948-3:2018 Nuclear medicine instrumentation. Routine tests. Positron emission tomographs
BS EN ISO 21987:2017 Ophthalmic optics. Mounted spectacle lenses
BS EN ISO 10939:2017 Ophthalmic instruments. Slit-lamp microscopes
BS EN ISO 11381:2016 Ophthalmic optics. Spectacle frames. Screw threads
BS EN ISO 11979-10:2018 Ophthalmic implants. Intraocular lenses. Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes
BS EN ISO 14534:2015 Ophthalmic optics. Contact lenses and contact lens care products. Fundamental requirements
BS EN ISO 8596:2018 Ophthalmic optics. Visual acuity testing. Standard and clinical optotypes and their presentation
BS ISO 19979:2018 Ophthalmic optics. Contact lenses. Hygienic management of multipatient use trial contact lenses
PD ISO/TR 22979:2017 Ophthalmic implants. Intraocular lenses. Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
BS EN ISO 18369-2:2017 Ophthalmic optics. Contact lenses. Tolerances
BS EN ISO 11986:2017 Ophthalmic optics. Contact lenses and contact lens care products. Determination of preservative uptake and release
BS EN ISO 15747:2019 Plastic containers for intravenous injections
BS EN ISO 21987:2017 Ophthalmic optics. Mounted spectacle lenses
BS EN ISO 22870:2016 Point-of-care testing (POCT). Requirements for quality and competence
BS ISO 11040-4:2015 Prefilled syringes. Glass barrels for injectables and sterilized subassembled syringes ready for filling
BS ISO 11040-6:2019 Prefilled syringes. Plastic barrels for injectables and sterilized subassembled syringes ready for filling
BS EN ISO 23500-1:2019 Preparation and quality management of fluids for haemodialysis and related therapies. General requirements
BS EN ISO 23500-2:2019 Preparation and quality management of fluids for haemodialysis and related therapies. Water treatment equipment for haemodialysis applications and related therapies
BS EN ISO 23500-3:2019 Preparation and quality management of fluids for haemodialysis and related therapies. Water for haemodialysis and related therapies
BS EN ISO 23500-5:2019 Preparation and quality management of fluids for haemodialysis and related therapies. Quality of dialysis fluid for haemodialysis and related therapies
BS EN ISO 10524-1:2019 Pressure regulators for use with medical gases. Pressure regulators and pressure regulators with flow-metering devices
BS EN ISO 10524-2:2019 Pressure regulators for use with medical gases. Manifold and line pressure regulators
BS EN ISO 10524-3:2019 Pressure regulators for use with medical gases. Pressure regulators integrated with cylinder valves (VIPRs)
BS EN ISO 22675:2016 Prosthetics. Testing of ankle-foot devices and foot units. Requirements and test methods
BS ISO 13405-1:2015 Prosthetics and orthotics. Classification and description of prosthetic components. Classification of prosthetic components
BS EN ISO 10328:2016 Prosthetics. Structural testing of lower-limb prostheses. Requirements and test methods
BS ISO 13405-2:2015 Prosthetics and orthotics. Classification and description of prosthetic components. Description of lower limb prosthetic components
BS ISO 13405-3:2015 Prosthetics and orthotics. Classification and description of prosthetic components. Description of upper limb prosthetic components
BS EN 13976-1:2018 Rescue systems. Transportation of incubators. Interface requirements
BS EN 13976-2:2018 Rescue systems. Transportation of incubators. System requirements
BS ISO 12891-1:2015 Retrieval and analysis of surgical implants. Retrieval and handling
BS EN ISO 80369-1:2018 Small-bore connectors for liquids and gases in healthcare applications. General requirements
BS EN ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices. Requirements and test methods
BS EN ISO 7864:2016 Sterile hypodermic needles for single use. Requirements and test methods
BS EN ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin
BS EN ISO 7153-1:2016 Surgical instruments. Materials. Metals
BS EN ISO 1135-5:2015 Transfusion equipment for medical use. Transfusion sets for single use with pressure infusion apparatus
BS ISO 16840-2:2018 Wheelchair seating. Determination of physical and mechanical characteristics of seat cushions intended to manage tissue integrity
BS ISO 7176-2:2017 Wheelchairs. Determination of dynamic stability of electrically powered wheelchairs
BS ISO 7176-6:2018 Wheelchairs. Determination of maximum speed of electrically powered wheelchairs
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