周倩 2006年进入亿博检测技术有限公司，担任高级销售顾问。
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哪些产品要CE认证
亿博医疗器械CE认证服务机构，专业办理医疗器械CE认证，拥有资质认可的实验室，有产品想要办理CE认证可以咨询我们，咨询热线：135-4327-2815
如何知道产品要不要CE认证和打CE标志呢? 企业产品出口到欧盟和欧洲自由贸易协会的28个成员国中的任何一个，并且产品属于下列任何一类，将非常可能需要进行CE认证：
1. 燃气炉具 Appliances Burning Gaseous Fuels (AppliGas)
The "appliances burning gaseous fuels" used for cooking, heating, hot water production, refrigeration, lighting or washing and having, where applicable, a normal water temperature not exceeding 105 gC. Forced draught burners and heating bodies to be equipped with such burners will also be considered as appliances.
The "gaseous fuel" means any fuel which is in a gaseous state at a temperature of 15 gC under a pressure of 1 bar.
2.
3. 载人的索道装置 Cableway Installations to Carry Persons
The "cableway installations designed to carry persons" shall mean installations made up of several components, designed, manufactured, assembled and put into service with the object of carrying persons.
These on-site installations are used for the carriage of persons in vehicles or by towing devices, whereby the suspension and/or traction is provided by cables positioned along the line of travel. .
4. 低电压电气设备 Low Voltage Electrical Equipment
The "Electrical Equipment" means any equipment designed for use with a voltage rating of between 50 and 1000 V for alternating current (A.C.) and between 75 and 1500 V for direct current (D.C.). Therefore, it is called often "Low Voltage Electrical Equipment" which includes the vast majority of electrical equipment in everyday use.
5. 建筑产品 Construction Products
The "construction product" means any product which is produced for incorporation in a permanent manner in construction works, including both buildings and civil engineering works.
6. 使用于具有爆炸性环境中的设备和防护系统
Equipment and Protective Systems for Used in Potentially Explosive Atmospheres (Atex)
o Equipment means machines, apparatus, fixed or mobile devices, control components and instrumentation thereof and detection or prevention systems which, separately or jointly, are intended for the generation, transfer, storage, measurement, control and conversion of energy for the processing of material and which are capable of causing an explosion through their own potential sources of ignition.
o Protective systems means design units which are intended to halt incipient explosions immediately and/or to limit the effective range of explosion flames and explosion pressures. Protective systems may be integrated into equipment or separately placed on the market for use as autonomous systems.
o Components means any item essential to the safe functioning of equipment and protective systems but with no autonomous function. Explosive atmospheres Mixture with air, under atmospheric conditions, of flammable substances in the form of gases, vapours, mists or dusts in which, after ignition has occurred, combustion spreads to the entire unburned mixture.
Potentially explosive atmosphere means an atmosphere which could become explosive due to local and operational conditions. .
7. 民用爆破器材 Explosives for Civil Uses
The "Explosives" here shall mean the materials and articles considered to be such in the United Nations recommendations on the transport of dangerous goods and falling within Class 1 of those recommendations.
8. 燃烧液体或气体燃料的热水锅炉 Hot Water Boilers
The "hot-water boilers" here means a boiler fired by liquid or gaseous fuels with a rated output of between 4 kW and 400 kW (including 4 kW and 400 kW).
9. 家用电冰箱或电冷柜 Household Refrigerators & Freezers
10. 升降机 Lift
The "lift" here means an appliance serving specific levels, having a car moving along guides which are rigid and inclined at an angle of more than 15 degrees to the horizontal and intended for the transport of:
- persons,
- persons and goods,
- goods alone if the car is accessible, that is to say, a person may enter it without difficulty, and fitted with controls situated inside the car or within reach of a person inside.
11. 机械 Machinery
the "machinery" means:
o an assembly of linked parts or components, at least one of which moves, with the appropriate actuators, control and power circuits, etc., joined together for a specific application, in particular for the processing, treatment, moving or packaging of a material,
o an assembly of machines which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole,
o interchangeable equipment modifying the function of a machine, which is placed on the market for the purpose of being assembled with a machine or a series of different machines or with a tractor by the operator himself in so far as this equipment is not a spare part or a tool.
12. 航海设备 Marine Equipment
The "Marine Equipment" here means items listed in Directive 96/98/ec Annexes A.1 and A.2 which must be placed on board a ship for use in order to comply with international instruments or are voluntarily placed on board for use, and for which the approval of the flag State administration is required according to international instruments.
13. 医疗器械 Medical Devices
A "Medical Device" is defined in Directive (93/42/EEC) as: any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for the proper application, intended by the manufacturer to be used for human beings for the purpose of :
o diagnosis, prevention, monitoring, treatment or alleviation of a disease, an injury or a handicap.
o investigation, replacement or modification of the anatomy or of a physiological process.
o 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 by such means.
14. 主动可植入医疗器械 Active Implantable Medical Devices
The "active medical device" means any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity
The "active implantable medical device" means 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.
15. 体外诊断医疗器械 In Vitro Diagnostic Medical Devices
The "in vitro diagnostic medical device" means 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:
- concerning a physiological or pathological state, or
- concerning a congenital abnormality, or
- to determine the safety and compatibility with potential recipients, or
- to monitor therapeutic measures..
16. 非自动称量仪器 Non-automatic Weighing Instruments
A "Weighing Instrument" is defined as a measuring instrument serving to determine the mass of a body by using the action of gravity on that body. A weighing instrument may also serve to determine other mass-related magnitudes, quantities, parameters or characteristics.
A "non-automatic weighing instrument" is defined as a weighing instrument requiring the intervention of an operator during weighing.
17. 无线电及电信终端设备 Radio Equipment & Telecommunications Terminal Equipment (R&TTE)
18. 个人防护设备 Personal Protective Equipment (PPE)
The "personal protective equipment" means any device or appliance designed to be worn or held by an individual for protection against one or more health and safety hazards.
19. 简单压力容器 Simple Pressure Vessels
The "simple pressure vessel" means any welded vessel subjected to an internal gauge pressure greater than 0,5 bar which is intended to contain air or nitrogen and which is not intended to be fired.
20. 压力设备 Pressure Equipment
The "Pressure Equipment" means vessels, piping, safety accessories and pressure accessories.
Where applicable, pressure equipment includes elements attached to pressurized parts, such as flanges, nozzles, couplings, supports, lifting lugs, etc.
'Vessel` means a housing designed and built to contain fluids under pressure including its direct attachments up to the coupling point connecting it to other equipment. A vessel may be composed of more than one chamber.
'Piping` means piping components intended for the transport of fluids, when connected together for integration into a pressure system. Piping includes in particular a pipe or system of pipes, tubing, fittings, expansion joints, hoses, or other pressure-bearing components as appropriate. Heat exchangers consisting of pipes for the purpose of cooling or heating air shall be considered as piping.
'Safety accessories` means devices designed to protect pressure equipment against the allowable limits being exceeded. Such devices include:
- devices for direct pressure limitation, such as safety valves, bursting disc safety devices, buckling rods, controlled safety pressure relief systems (CSPRS), and
- limiting devices, which either activate the means for correction or provide for shutdown or shutdown and lockout, such as pressure switches or temperature switches or fluid level switches and 'safety related measurement control and regulation (SRMCR)` devices.
'Pressure accessories` means devices with an operational function and having pressure-bearing housings.
'Assemblies` means several pieces of pressure equipment assembled by a manufacturer to constitute an integrated and functional whole.
21. 休闲用船只 Recreational Craft
The "Recreational craft" means any boat of any type, regardless of the means of propulsion, from 2,5 to 24 m hull length, measured according to the appropriate harmonized standards intended for sports and leisure purposes.
22. 玩具 Toys
A "toy" shall mean any product or material designed or clearly intended for use in play by children of less than 14 years of age.
23. 跨欧洲高速列车系统 Trans-European Conventional Rail System
The "Trans-European Conventional Rail system" means the structure composed of lines and fixed installations, of the trans-European transport network, built or upgraded for conventional rail transport and combined rail transport, plus the rolling stock designed to travel on that infrastructure.
咨询服务热线：如果您想办理医疗设备CE认证或者想了解更多资讯，请点击【亿博认证】在线客服和咨询师，或者致电：135-4327-2815/189-9564-0729.
咨询服务热线：如果您想办理医疗设备CE认证或者想了解更多资讯，请点击【亿博认证】在线客服和咨询师，或者致电：135-4327-2815/189-9564-0729.
有产品办理检测认证或想了解更多详情资讯，请联系亿博检测中心:
亿博检测高级销售顾问certified engineer
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