EU Directives and Harmonized Standards
Medical Devices: General (Directive 93/42/EEC)
In 1998 the European Union Medical Devices Directive became mandatory for all manufacturers selling medical devices in the European marketplace. The Medical Devices Directive is concerned with all medical devices, from sterile Gants to electronic monitoring equipment and complex MRI scanners. Companies manufacturing Class I Sterile, Class I Measuring, IIa, IIb or Class III devices that fall within the scope of the Medical Devices Directive must meet the essential requirements of that law.
Contains:
Biocompatibility of medical and dental materials and devices
Chemical disinfectants and antiseptics
Clinical investigation of medical devices
Dentistry
Electrical equipment in medical practice
Electroacoutics
Hearing aids and audiometers
Lasers and laser-related equipment
Medical alarms and signals
Medical devices utilizing tissues
Non-active medical devices
Non-active surgical implants
Ophthalmic optics
Optical radiation safety and laser equipment
Quality systems - particular requirements for the EN ISO 9000 series
Rescue systems
Respiratory and anaesthetic equipment
Risk Analysis Sterilization of medical devices
Sterilizers for medical purposes
Symbols, information - nomenclature for regulatory data exchange
Technical aids for disabled persons
Transportable gas cylinders
Medical Devices: Active Implantable (Directive 90/385/EEC)
The Active Implantable Medical Devices Directive applies to devices and their accessories. The Directive covers implantable products such as cardiac pacemakers, defibrillators, infusion pumps, diaphragm stimulators, bladder stimulators, and neurostimulators. In addition, the Directive covers accessories and software such as image-enhancing software intended for diagnostic purposes. “Active” implies that the function of these devices is dependent upon a source of electrical energy or any source of power other than that directly generated by the human body or gravity. An “Implantable Medical Device” refers to any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure. Active Implantable Devices must be designed and manufactured such that when implanted under the conditions and for the purposes laid down, they will not compromise the clinical condition or safety of patients. They must not pose any risk to the person implanting them or where applicable, to any other persons.
Contains:
Active implantable medical devices
Biocompatibility of medical and dental materials and devices
Clinical investigation of medical devices
Criteria for conformity assessment bodies
Electrical equipment in medical practice
Medical alarms and signals
Quality systems - particular requirements for the EN ISO 9000 series
Risk Analysis
Sterilization of medical devices
Sterilizers for medical purposes
Symbols, information - nomenclature for regulatory data exchange
Medical Devices: In Vitro Diagnostic (Directive 98/79/EC)
This Directive was recently introduced in the EU as the third in a series of Medical Device Directives. The purpose of the Directive is to ensure that only safe and effective products are sold in the European market, with clearly outlined regulations regarding manufacturing, import and marketing. On December 7, 2003, compliance to the IVD Directive became mandatory. This Directive defines an in vitro diagnostic medical device as any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information (a) concerning a physiological or pathological state, or (b) concerning a congenital abnormality, or (c) to determine the safety and compatibility with potential recipients, or (d) to monitor therapeutic measures. Examples include HIV test kits; blood gas analysers; multi-analyte control sera; immunoassay analysers ; blood collection tubes and specimen containers; microtitre plate readers, claimed for diagnostic use; and media for growing cultures, used for diagnostic purposes.
Contains:
Automatic operating analytical appliances inc. In Vitro Diagnostic Medical Devices
In vitro diagnostic medical devices
Safety of measuring, control and laboratory equipment
Symbols, information - nomenclature for regulatory data exchange
Medical Devices: Low Voltage Equipment/Medical Subset (EU Directive 73/23/EEC)
The Low Voltage Directive (LVD) applies to electrical equipment designed for use with a voltage rating of between 50 and 1000 V for alternating current, and between 75 and 1500 V for direct current, and whose primary safety risk is of an electrical nature. Rated voltage refers to the input or output voltage of the equipment and not voltages which are generated internally. The Directive requires manufacturers to offer safety protection against electrical hazards arising from the equipment, and protection against hazards caused by external influences on the equipment. Broadly, the scope of the Directive covers goods designed to operate within those voltage limits, including electrical appliances; lighting equipment; switch gear and control gear; electric wiring; appliance couplers and cord sets; electrical installation equipment; and electrical equipment intended for incorporation into other equipment such as transformers and motors. The LVD lays down eleven “safety objectives”, which represent the essential requirements of this Directive.
Contains:
| Low Voltage Equipment Collection |
| Online subscription to multiple documents |
 Subscribe |
Alarm systems
Appliance couplers
Audio, video and multimedia systems and equipment
Automatic operating analytical appliances inc. In Vitro Diagnostic Medical Devices
Basic and safety principles for man-machine interface, marking and identification
Cable management
Cable networks for television signals, sound signals and interactive services
Connecting devices
Connectors
Conversion adaptors for industrial use
Degrees of protection provided by enclosures
Devices
Electric cables
Electrical accessories
Electroacoustics
Electromagnetic fields in the human environment
Fire hazard testing
Hearing aids and audiometers
Insulation co-ordination for low-voltage equipment
Isolating and safety isolating transformers
Lamps
Low-voltage fuses
Low-voltage switchgear and controlgear assemblies
Low-voltage switchgear and controlgear including dimensional standardization Luminaires and associated equipment
Mains communicating systems
Miniature fuses
Optical radiation safety and laser equipment
Power capacitors
Power electronics
Relays
Safety of electronic equipment within the fields of Audio/Video, Info Tech & Communication Tech
Safety of machinery: electrotechnical aspects
Safety of measuring, control, and laboratory equipment
Small power transformers, reactors, supply units and similar products
Transmitting equipment for radiocommunication
Medical Devices: Low Voltage Equipment/Complete (EU Directive 73/23/EEC)
Contains the same categories as the Medical subset plus:
Automatic controls for household use
Circuit breakers and similar devices for household and similar applications
Electric arc welding equipment
Electric resistance welding
Electrical installations and protection against electric shock
Electrical installations of buildings: Protection against thermal effects
Electrical systems for electric road vehicles
Equipment and tools for live working
Gas detectors
Home and Building Electronic Systems (HBES)
Industrial electroheating equipment
Industrial plugs and socket-outlets
Measuring equipment for electrical and electromagnetic quantities
Measuring relays and protection equipment
Photoelectronic controls for road lighting
Rotating machinery
Safety of household and similar electrical appliances
Solar photovoltaic energy systems
Switches for appliances
Switches for household and similar fixed electrical installations
Wind turbine systems
Medical Devices: Electromagnetic Compatibility (EMC) (Directive 89/336/EEC)
The Directive is one of the widest in its application and all electrical products must comply. The only exceptions are for components or subassemblies with no intrinsic function (i.e. their use cannot be defined unless they are combined with other components), and certain electrical products and systems that are already covered by other Directives. The requirements of the Directive are very simple - it basically states that products must not emit unwanted electromagnetic pollution (interference). Because there is a certain amount of electromagnetic pollution in the environment, the Directive also states that products must be immune to a reasonable amount of interference. The EMC Directive applies to all electrical and electronic appliances, together with equipment and installations containing electrical and/or electronic components that are liable to cause electromagnetic disturbance, or the performance of which is liable to be affected by such disturbances.
Contains:
Alarm systems
Automatic controls for household use
Broadcasting, TV, audio
Cable networks for television signals, sound signals and interactive services
Circuit breakers and similar devices for household and similar applications
Communication, signaling and processing system
Construction equipment and building material machines - safety
DECT Digital Enhanced Cordless Telecommunications Devices
Doors, windows, shutters, building hardware and curtain walling
DRRS Digital Radio Relay System
Electric arc welding equipment
Electric resistance welding
Electric supply and earthing systems for public transport equipment and ancillary apparatus (fixed installations)
Electrical accessories
Electrical and electronic applications for railways
Electrical apparatus for detection and measurement of combustible gases to be used in industrial & commercial potentially explosive atmospheres
Electromagnetic compatibility (EMC)
Electromechanical material on board rolling stock
EMC products
Equipment for electrical energy measurement and load control
FWS Fixed Wireless Access (cf RLL, WLL, FRA)
GMDSS Global Maritime Distress and Safety system
GSM Global System for Mobile communications
HIPERLAN High Performance Radio Local Area Networks (LAN)
Home and Building Electronic Systems (HBES)
Industry trucks - safety
Low-voltage switchgear and controlgear assemblies
Low-voltage switchgear and controlgear including dimensional standardization
Luminaires and associated equipment
Mains communicating systems
Maritime navigation and radiocommunication equipment and systems
Measuring relays and protection equipment
Passenger, goods and service lifts PMR Private Mobile Radio Power electronics
Power system control and associated communications
Radio Relays Road traffic signal systems
Rotating machinery
Safety of machinery: electrotechnical aspects
Safety of measuring, control and laboratory equipment
Satellite (Cf terrestrial, aeronautical, maritime)
Short Range (radio)
Small power transformers, reactors, supply units and similar products
Switches for household and similar fixed electrical installations
System aspects TETRA TErrestrial Trunked RAdio system
Tractors and machinery for agriculture and forestry