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93/42/EEC Medical Devices Directive(MDD)
Before you can market your medical device in the EU, your product must meet the essential requirements in Annex 1 of the Medical
Devices Directive (MDD)
Scope of 93/42/EEC:
This Directive shall apply to medical devices and their accessories.
For the purposes of this Directive, accessories shall be treated as medical
devices in their own right. Both medical devices and accessories shall hereinafter be termed devices.
Definitions of 93/42/EEC:
‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination,
including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its
proper application, intended by the manufacturer to be used for human beings for the purpose of:
diagnosis, prevention, monitoring, treatment or alleviation of disease,
diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
investigation, replacement or modification of the anatomy or of a physiological process,
control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but
which may be assisted in its function by such means.
Harmonised standards under Directive 93/42/EEC:
Sterilization
– Steam sterilizers – Large sterilizers
EN 455-4:2009
Medical gloves for single use – Part 4: Requirements and testing for shelf life
determination
EN 794-3:2009
Lung ventilators – Part 3: Particular requirements for emergency and transport
ventilators
Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems
Non-invasive sphygmomanometers – Part 4: Test procedures to determine the overall system
accuracy of automated non-invasive sphygmomanometers
Tracheostomy tubes – Part 2: Paediatric tubes
Sterilizers for medical purposes – Ethylene oxide sterilizers – Requirements and test methods
Catheters other than intravascular catheters – Test methods for common properties
Dentistry -Medical devices for dentistry – Instruments
Dentistry -Medical devices for dentistry – Equipment
Dentistry -Medical devices for dentistry – Materials
Dentistry – Medical devices for dentistry – Dental implants
Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment – Lock fittings
Medical vehicles and their equipment – Road ambulances
Anaesthetic reservoir bags
Patient handling equipment used in road ambulances – Part 3: Heavy duty stretcher
Patient handling equipment used in road ambulances – Part 4: Foldable patient transfer chair
Patient handling equipment used in road ambulances – Part 5: Stretcher support
Walking aids - General requirements and test methods
collapsible containers for human blood and blood components – Part 2:
Graphical symbols for use on labels and instruction leaflets
collapsible containers for human blood and blood components – Part 3: Blood
bag systems with integrated features
Natural latex
rubber condoms – Requirements and test methods
Anaesthetic
and respiratory equipment – Laryngoscopes for tracheal intubation
hypodermic syringes for single use – Part 3: Auto-disable syringes for
fixed-dose immunization
hypodermic syringes for single use – Part 4: Syringes with re-use prevention
Respiratory
tract humidifiers for medical use – Particular requirements for respiratory
humidification systems
concentrators for medical use – Safety requirements
Inhalational
anaesthesia systems – Part 2: Anaesthetic breathing systems
Inhalational
anaesthesia systems – Part 3: Transfer and receiving systems of active
anaesthetic gas scavenging systems
Inhalational
anaesthesia systems – Part 4: Anaesthetic vapour delivery devices
Inhalational
anaesthesia systems – Part 5: Anaesthetic ventilators
Terminal units
for medical gas pipeline systems – Part 1: Terminal units for use with
compressed medical gases and vacuum
Terminal units
for medical gas pipeline systems – Part 2: Terminal units for anaesthetic gas
scavenging systems
Anaesthetic
and respiratory equipment – Heat and moisture exchangers (HMEs) for
humidifying respired gases in humans – Part 1: HMEs for use with minimum
tidal volumes of 250 ml
Anaesthetic
and respiratory equipment – Heat and moisture exchangers (HMEs) for
humidifying respired gases in humans – Part 2: HMEs for use with
tracheostomized patients having minimum tidal volumes of 250 ml
Neurosurgical
implants – Self-closing intracranial aneurysm clips
suction equipment – Part 1: Electrically powered suction equipment – Safety
requirements
suction equipment – Part 2: Manually powered suction equipment
suction equipment – Part 3: Suction equipment powered from a vacuum or
pressure source
Prosthetics –
Structural testing of lower-limb prostheses – Requirements and test methods
regulators for use with medical gases – Part 1: Pressure regulators and
pressure regulators with flow-metering devices
regulators for use with medical gases – Part 2: Manifold and line pressure
regulators
regulators for use with medical gases – Part 3: Pressure regulators
integrated with cylinder valves
regulators for use with medical gases – Part 4: Low-pressure regulators
Hoists for the
transfer of disabled persons – Requirements and test methods
single-use intravascular catheters – Part 1: General requirements
ventilators for medical use – Particular requirements for basic safety and
essential performance – Part 2: Home care ventilators for
ventilator-dependent patients
ventilators – Part 4: Particular requirements for operator-powered
resuscitators
ventilators for medical use – Particular requirements for basic safety and
essential performance – Part 6: Home-care ventilatory support devices
Biological
evaluation of medical devices – Part 1: Evaluation and testing within a risk
management process
Biological
evaluation of medical devices – Part 3: Tests for genotoxicity,
carcinogenicity and reproductive toxicity
Biological
evaluation of medical devices – Part 4: Selection of tests for interactions
with blood
Biological
evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
Biological
evaluation of medical devices – Part 6: Tests for local effects after
implantation
Biological
evaluation of medical devices – Part 7: Ethylene oxide sterilization
Biological
evaluation of medical devices – Part 9: Framework for identification and
quantification of potential degradation products
Biological
evaluation of medical devices – Part 11: Tests for systemic toxicity
Biological
evaluation of medical devices – Part 12: Sample preparation and reference
Biological
evaluation of medical devices – Part 13: Identification and quantification of
degradation products from polymeric medical devices
Biological
evaluation of medical devices – Part 14: Identification and quantification of
degradation products from ceramics
Biological
evaluation of medical devices – Part 15: Identification and quantification of
degradation products from metals and alloys
Biological
evaluation of medical devices – Part 16: Toxicokinetic study design for
degradation products and leachables
Biological
evaluation of medical devices – Part 17: Establishment of allowable limits
for leachable substances
Biological
evaluation of medical devices – Part 18: Chemical characterization of
Sterilization
of health care products – Ethylene oxide – Part 1: Requirements for
development, validation and routine control of a sterilization process for
medical devices
Sterilization
of health care products – Radiation – Part 1: Requirements for development,
validation and routine control of a sterilization process for medical devices
Sterilization
of health care products – Radiation – Part 2: Establishing the sterilization
Sterilization
of health care products – Biological indicators – Part 2: Biological
indicators for ethylene oxide sterilization processes
Sterilization
of health care products – Biological indicators – Part 3: Biological
indicators for moist heat sterilization processes
Sterilization
of health care products – Chemical indicators – Part 1: General requirements
Sterilization
of health care products – Chemical indicators – Part 3: Class 2 indicator
systems for use in the Bowie and Dick-type steam penetration test
Medical supply
Packaging for
terminally sterilized medical devices – Part 1: Requirements for materials,
sterile barrier systems and packaging systems
Packaging for
terminally sterilized medical devices – Part 2: Validation requirements for
forming, sealing and assembly processes
Sterilization
of medical devices – Microbiological methods – Part 1: Determination of a
population of microorganisms on products
Sterilization
of medical devices – Microbiological methods – Part 2: Tests of sterility
performed in the definition, validation and maintenance of a sterilization
Lasers and
laser-related equipment – Test method and classification for the laser
resistance of surgical drapes and/or patient protective covers – Part 1:
Primary ignition and penetration
Lasers and
laser-related equipment – Test method and classification for the
laser-resistance of surgical drapes and/or patient-protective covers – Part
2: Secondary ignition
Ophthalmic
implants – Intraocular lenses – Part 8: Fundamental requirements
Non active
surgical implants – Particular requirements for cardiac and vascular implants
– Part 2: Vascular prostheses including cardiac valve conduits
wheelchairs – Requirements and test methods
Electrically
powered wheelchairs, scooters and their chargers – Requirements and test
tubes intended for use with anaesthetic apparatus and ventilators
EN 12470-1:
thermometers – Part 1: Metallic liquid-in-glass thermometers with maximum
thermometers – Part 2: Phase change type (dot matrix) thermometers
thermometers – Part 3: Performance of compact electrical thermometers (non-predictive
and predictive) with maximum device
thermometers – Part 4: Performance of electrical thermometers for continuous
measurement
thermometers – Part 5: Performance of infra-red ear thermometers (with
maximum device)
Ophthalmic
optics – Spectacle frames – Requirements and test methods
Small steam
sterilizers
processing of health care products – Part 1: General requirements
processing of health care products – Part 2: Filtration
processing of health care products – Part 3: Lyophilization
processing of health care products – Part 4: Clean-in-place technologies
processing of health care products – Part 5: Sterilization in place
processing of health care products – Part 6: Isolator systems
devices – Quality management systems – Requirements for regulatory purposes
Respiratory
therapy equipment – Part 1: Nebulizing systems and their components
Respiratory
therapy equipment – Part 2: Tubing and connectors
Respiratory
therapy equipment – Part 3: Air entrainment devices
disinfectants and antiseptics – Quantitative suspension test for the
evaluation of fungicidal activity of chemical disinfectants for instruments
used in the medical area – Test method and requirements (phase 2, step 1)
vehicles and their equipment – Air ambulances – Part 1: Requirements for
medical devices used in air ambulances
Test methods
for primary wound dressings – Part 1: Aspects of absorbency
Test methods
for primary wound dressings – Part 2: Moisture vapour transmission rate of
permeable film dressings
disinfectants and antiseptics – Quantitative suspension test for the
evaluation of bactericidal activity in the medical area – Test method and
requirements (phase 2, step 1)
Concentrates
for haemodialysis and related therapies
Rescue systems
– Transportation of incubators – Part 1: Interface conditions
Rescue systems
– Transportation of incubators – Part 2: System requirements
Non-active
medical devices – Performance requirements and test methods for absorbent
cotton gauze and absorbent cotton and viscose gauze
Ophthalmic
optics – Specifications for ready-to-wear spectacles
investigation of medical devices for human subjects – Good clinical practice
Sterilizers
for medical purposes – Low temperature steam and formaldehyde sterilizers –
Requirements and testing
disinfectants and antiseptics – Quantitative suspension test for the
evaluation of mycobactericidal activity of chemical disinfectants in the
medical area including instrument disinfectants – Test methods and
requirements (phase 2, step 1)
Tracheal tubes
designed for laser surgery – Requirements for marking and accompanying
information
disinfectants and antiseptics – Quantitative carrier test for the evaluation
of bactericidal activity for instruments used in the medical area – Test
method and requirements (phase 2, step 2)
disinfectants and antiseptics – Quantitative carrier test for the evaluation
of fungicidal or yeasticidal activity for instruments used in the medical
area – Test method and requirements (phase 2, step 2)
disinfectants and antiseptics – Quantitative carrier test for the evaluation
of mycobactericidal or tuberculocidal activity of chemical disinfectants used
for instruments in the medical area – Test method and requirements (phase 2,
Non-active
surgical implants – Implants for osteosynthesis – Particular requirements
Non-active
surgical implants – Mammary implants – Particular requirements
Non-active
surgical implants – General requirements
Surgical masks
– Requirements and test methods
Ophthalmic
optics – Spectacle lenses – Fundamental requirements for uncut finished
vessels for human occupancy (PVHO) – Multi-place pressure chamber systems for
hyperbaric therapy – Performance, safety requirements and testing
Sterilization
of health care products – General requirements for characterization of a
sterilizing agent and the development, validation and routine control of a
sterilization process for medical devices
devices – Application of risk management to medical devices
Anaesthetic
and respiratory equipment – Compatibility with oxygen
Flow-metering
devices for connection to terminal units of medical gas pipeline systems
Ophthalmic
instruments – Fundamental requirements and test methods – Part 1: General
requirements applicable to all ophthalmic instruments
containers for intravenous injections
Ophthalmic
implants – Ophthalmic viscosurgical devices
Washer-disinfectors
– Part 1: General requirements, terms and definitions and tests
Washer-disinfectors
– Part 2: Requirements and tests for washer-disinfectors employing thermal
disinfection for surgical instruments, anaesthetic equipment, bowls, dishes,
receivers, utensils, glassware, etc.
Washer-disinfectors
– Part 3: Requirements and tests for washer-disinfectors employing thermal
disinfection for human waste containers
Washer-disinfectors
– Part 4: Requirements and tests for washer-disinfectors employing chemical
disinfection for thermolabile endoscopes
Symbol for use
in the labelling of medical devices – Requirements for labelling of medical
devices containing phthalates
Instrumentation
for use in association with non-active surgical implants – General
requirements
Technical aids
for disabled persons – Environmental control systems for daily living
Sleep apnoea
breathing therapy – Part 1: Sleep apnoea breathing therapy equipment
Sleep apnoea
breathing therapy – Part 2: Masks and application accessories
Sterilization
of medical devices – Information to be provided by the manufacturer for the
processing of resterilizable medical devices
Sterilization
of health care products – Moist heat – Part 1: Requirements for the
development, validation and routine control of a sterilization process for
medical devices
Transportable
liquid oxygen systems for medical use – Particular requirements
Respiratory
equipment – Infant monitors – Particular requirements
devices for conserving oxygen and oxygen mixtures – Particular requirements
Rail systems
for supporting medical equipment
fittings with a 6% (Luer) taper for syringes, needles and certain other
medical equipment – Part 1: General requirements
Medical gloves
– Determination of removable surface powder
Non-active
surgical implants – Joint replacement implants – Particular requirements
Non-active
surgical implants – Joint replacement implants – Specific requirements for
hip-joint replacement implants
Non-active
surgical implants – Joint replacement implants – Specific requirements for
knee-joint replacement implants
Needle-free
injectors for medical use – Requirements and test methods
High-pressure
flexible connections for use with medical gas systems
Ophthalmic
optics – Mounted spectacle lenses
devices utilizing animal tissues and their derivatives – Part 1: Application
of risk management
devices utilizing animal tissues and their derivatives – Part 2: Controls on
sourcing, collection and handling
devices utilizing animal tissues and their derivatives – Part 3: Validation
of the elimination and/or inactivation of viruses and transmissible
spongiform encephalopathy (TSE) agents
External limb
prostheses and external orthoses – Requirements and test methods
drapes, gowns and clean air suits, used as medical devices, for patients,
clinical staff and equipment – Test method to determine the resistance to wet
bacterial penetration
Clothing for
protection against infectious agents – Test method for resistance to dry
microbial penetration
Prosthetics –
Testing of ankle-foot devices and foot units – Requirements and test methods
system filters for anaesthetic and respiratory use – Part 1: Salt test method
to assess filtration performance
system filters for anaesthetic and respiratory use – Part 2: Non-filtration aspects
Anaesthetic
and respiratory equipment – Peak expiratory flow meters for the assessment of
pulmonary function in spontaneously breathing humans
Cardiovascular
implants – Endovascular devices – Part 1: Endovascular prostheses
Cardiovascular
implants – Endovascular devices – Part 2: Vascular stents
Anaesthetic
and respiratory equipment – Spirometers intended for the measurement of time
forced expired volumes in humans
Instruments
for surgery, scalpels with detachable blades, fitting dimensions
Non-invasive
sphygmomanometers – Part 1: Requirements and test methods for non-automated
measurement type
Electroacoustics
– Hearing aids — Part 13: Electromagnetic compatibility (EMC)
Determination
of the permanent filtration of X-ray tube assemblies
electrical equipment – Dose area product meters
electrical equipment — Part 1: General requirements for basic safety and
essential performance
Medical electrical
equipment — Part 1-2: General requirements for basic safety and essential
performance – Collateral standard: Electromagnetic compatibility –
Requirements and tests
electrical equipment — Part 1-3: General requirements for basic safety and
essential performance – Collateral Standard: Radiation protection in
diagnostic X-ray equipment
electrical equipment — Part 1-6: General requirements for basic safety and
essential performance – Collateral Standard: Usability
electrical equipment — Part 1-6: General requirements for basic safety and
essential performance – Collateral standard: Usability
electrical equipment — Part 1-8: 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
electrical equipment — Part 1-10: General requirements for basic safety and
essential performance – Collateral Standard: Requirements for the development
of physiologic closed-loop controllers
electrical equipment — Part 1-11: General requirements for basic safety and
essential performance – Collateral standard: Requirements for medical
electrical equipment and medical electrical systems used in the home
healthcare environment
electrical equipment — Part 2-1: Particular requirements for the safety of
electron accelerators in the range of 1 MeV to 50 MeV
electrical equipment — Part 2-2: Particular requirements for the basic
safety and essential performance of high frequency surgical equipment and high
frequency surgical accessories
electrical equipment — Part 2: Particular requirements for the safety of
short-wave therapy equipment
electrical equipment — Part 2-4: Particular requirements for the safety of
cardiac defibrillators
electrical equipment — Part 2-5: Particular requirements for the safety of
ultrasonic physiotherapy equipment
electrical equipment — Part 2: Particular requirements for the safety of
therapeutic X-ray equipment operating in the range 10 kV to 1 MV
electrical equipment — Part 2-10: Particular requirements for the safety of
nerve and muscle stimulators
Medical electrical
equipment — Part 2-11: Particular requirements for the safety of gamma beam
therapy equipment
electrical equipment — Part 2-12: Particular requirements for the safety of
lung ventilators – Critical care ventilators
electrical equipment — Part 2-13: Particular requirements for the safety and
essential performance of anaesthetic systems
electrical equipment — Part 2-16: Particular requirements for the safety of
haemodialysis, haemodiafiltration and haemofiltration equipment
electrical equipment — Part 2-17: Particular requirements for the safety of
automatically-controlled brachytherapy afterloading equipment
electrical equipment — Part 2: Particular requirements for the safety of
endoscopic equipment
electrical equipment — Part 2-19: Particular requirements for the basic
safety and essential performance of infant incubators
electrical equipment — Part 2-20: Particular requirements for the basic
safety and essential performance of infant transport incubators
electrical equipment — Part 2-21: Particular requirements for the basic
safety and essential performance of infant radiant warmers
electrical equipment — Part 2: Particular requirements for the safety of
diagnostic and therapeutic laser equipment
electrical equipment — Part 2-23: Particular requirements for the safety,
including essential performance, of transcutaneous partial pressure
monitoring equipment
electrical equipment — Part 2-24: Particular requirements for the safety of
infusion pumps and controllers
electrical equipment — Part 2-25: Particular requirements for the safety of
electrocardiographs
electrical equipment — Part 2-26: Particular requirements for the safety of
electroencephalographs
electrical equipment — Part 2-27: Particular requirements for the safety,
including essential performance, of electrocardiographic monitoring equipment
electrical equipment — Part 2: Particular requirements for the safety of
X-ray source assemblies and X-ray tube assemblies for medical diagnosis
electrical equipment — Part 2-28: Particular requirements for the basic
safety and essential performance of X-ray tube assemblies for medical
electrical equipment — Part 2-29: Particular requirements for the basic
safety and essential performance of radiotherapy simulators
Medical electrical
equipment — Part 2-30: Particular requirements for the safety, including
essential performance, of automatic cycling non-invasive blood pressure
monitoring equipment
electrical equipment — Part 2-33: Particular requirements for the safety of
magnetic resonance equipment for medical diagnosis
electrical equipment — Part 2-34: Particular requirements for the safety,
including essential performance, of invasive blood pressure monitoring
electrical equipment — Part 2: Particular requirements for the safety of
blankets, pads and mattresses, intended for heating in medical use
electrical equipment — Part 2: Particular requirements for the safety of
equipment for extracorporeally induced lithotripsy
electrical equipment — Part 2-37: Particular requirements for the basic
safety and essential performance of ultrasonic medical diagnostic and
monitoring equipment
electrical equipment — Part 2-38: Particular requirements for the safety of
electrically operated hospital beds
electrical equipment — Part 2-39: Particular requirements for basic safety
and essential performance of peritoneal dialysis equipment
electrical equipment — Part 2-40: Particular requirements for the safety of
electromyographs and evoked response equipment
electrical equipment — Part 2-41: Particular requirements for the safety of
surgical luminaires and luminaires for diagnosis
electrical equipment — Part 2-41: Particular requirements for basic safety
and essential performance of surgical luminaires and luminaires for diagnosis
electrical equipment — Part 2-43: Particular requirements for the safety of
X-ray equipment for interventional procedures
electrical equipment — Part 2-43: Particular requirements for basic safety
and essential performance of X-ray equipment for interventional procedures
electrical equipment — Part 2-44: Particular requirements for the basic
safety and essential performance of X-ray equipment for computed tomography
electrical equipment — Part 2-45: Particular requirements for the safety of
mammographic X-ray equipment and mammographic stereotactic devices
electrical equipment — Part 2-46: Particular requirements for the safety of
operating tables
electrical equipment — Part 2-47: Particular requirements for the safety,
including essential performance, of ambulatory electrocardiographic systems
electrical equipment — Part 2-49: Particular requirements for the safety of
multifunction patient monitoring equipment
Medical electrical
equipment — Part 2-50: Particular requirements for the basic safety and
essential performance of infant phototherapy equipment
electrical equipment — Part 2-51: Particular requirements for safety,
including essential performance, of recording and analysing single channel
and multichannel electrocardiographs
electrical equipment — Part 2-52: Particular requirements for basic safety
and essential performance of medical beds
electrical equipment — Part 2-54: Particular requirements for the basic
safety and essential performance of X-ray equipment for radiography and
radioscopy
Diagnostic
X-ray imaging equipment – Characteristics of general purpose and mammographic
anti-scatter grids
Electroacoustics
– Audiological equipment — Part 1: Pure-tone audiometers
Audiometers —
Part 2: Equipment for speech audiometry
Electroacoustics
– Audiometric equipment — Part 3: Test signals of short duration
Audiometers —
Part 4: Equipment for extended high-frequency audiometry
Radiotherapy
equipment – Coordinates, movements and scales
Radiotherapy
equipment – Coordinates, movements and scales
electrical equipment – Dosimetric instruments used for non-invasive
measurement of X-ray tube voltage in diagnostic radiology
electrical equipment – Requirements for the safety of radiotherapy treatment
planning systems
electrical equipment – Characteristics of digital X-ray imaging devices —
Part 1: Determination of the detective quantum efficiency
electrical equipment – Characteristics of digital X-ray imaging devices —
Part 1-2: Determination of the detective quantum efficiency – Detectors used
in mammography
electrical equipment – Characteristics of digital X-ray imaging devices —
Part 1-3: Determination of the detective quantum efficiency – Detectors used
in dynamic imaging
Medical device
software – Software life-cycle processes
devices – Application of usability engineering to medical devices
electrical equipment — Part 2-35: Particular requirements for the basic
safety and essential performance of heating devices using blankets, pads and
mattresses and intended for heating in medical use
electrical equipment — Part 2-58: Particular requirements for the basic
safety and essential performance of lens removal devices and vitrectomy
devices for ophthalmic surgery
electrical equipment — Part 2-59: Particular requirements for the basic
safety and essential performance of screening thermographs for human febrile
temperature screening
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