EU regulation REACH certification is "Chemicals Registration, Evaluation, Authorisation

and Restriction" (REGULATION concerning the Registration, Evaluation, Authorization and

Restriction of Chemicals) for short, is the establishment of the European Union, chemical

and since June 1, 2007 implementation product regulatory system.

The new EU chemicals policy, REACH certification (Chemicals Registration, Evaluation

and Authorization), the purpose of a high level of protection of human health and the

environment while promoting innovation and green chemicals.

December 18, 2006 EU regulation (EC) No.1907/2006 registered on chemicals, evaluation,

authorization and restriction, December 18, 2006 the EU Council Directive 2006/121/EC

modified by Commission Directive 67/548/EEC (classification of dangerous substances,

packaging and labeling) on December 30, 2006 published in the official Journal.

REACH will be implemented on June 1, 2007, will replace the nearly 40 existing EU

regulations and directives, to provide a simple system with a better way to manage chemicals.

VDE certification stands for Prufstelle Testing and Certification Institute, which means

the German Institute of Electrical Engineers . Directly involved in the German national

standards , VDE consists of approximately 30,000 organizations and individual members .

These members mainly from the federal government / organizations representing each

state / industry research institutions .

VDE Testing & Certification Institute (VDE Testing and Certification Institute) is located in

Offenbach, Germany offerbach is a German Institute of Electrical Engineers Association

(Verband Deutscher Elektrotechniker, referred to as VDE) belongs, was founded in 1920 .

As a neutral and independent body . VDE laboratory based applications , according to

German VDE standards or European standard EN or IEC International Electrotechnical

Commission standards for inspection and certification of electrical products , is one of

the prestigious European certification bodies in the world 's most experienced . It is

nearly 2200 customers each year and 2,700 German companies in other countries to

complete a total of 18 000 certification program. So far, nearly 50 countries worldwide

the 200,000 kinds of electrical products have VDE mark. In many countries, VDE

certification mark is even more famous than their own certification mark , especially

importers and exporters to be recognized and valued.

After VDE laboratories in accordance with the strict standards testing and certification

of products, consumers can rest assured .

Survey results showed that: 62% of Germans already know VDE mark , which thus

became one of the most famous security token . Most people think of safety markings

on the importance of electrical supplies in Germany, people familiar with the VDE

mark has a 77% holding this attitude. 73% of German citizens considered by a neutral

body to conduct security checks "important" or " very important " for electrical products.

Certification and inspection is one of Europe's most testing organizations test

experience , is authorized by the European Union and the International CB CE Notified

Body members . In Europe and internationally , electrical products get the CENELEC

European certification system , approved CECC electronic components Harmonized

system of quality assessment in Europe , the worldwide IEC electrical products,

electronic components , such as the certification system . The product is widely used

to assess household and commercial uses , including electrical , IT equipment ,

industrial and medical technology equipment , assembly materials and electronic

components , wire and cable.

Medical equipment products to be passed CE certification, need to do work in three areas .

First, the collection and certification of products related to EU technical regulations and

European (EN) standards, through digestion, absorption, into the enterprise product

standards.

Second, enterprises in strict accordance with the above product standards organization of

production, that is, the above-mentioned technical regulations and EN standards, implement

enterprise product design and development and manufacturing of the entire process .

Third, companies must build and maintain the standard ISO9000 + ISO13485 quality system

and obtained ISO9000 + ISO13485 certification.

Medical Device CE certification should follow the EU technical regulations and EN standards.

For the EU published Directive 18 categories of industrial products from these directives

structure, they can be divided into vertical and horizontal directive instruction . Vertical

instructions are specific products for the object, such as the Medical Device Directive ;

horizontal directive applies to all kinds of products , such as electromagnetic compatibility

directive , which applies to all electrical and electronic parts and components.

For medical devices , the applicable directives has fourteenth , the first and fifth ,

namely : 93/42/EEC Medical Device Directive , 73/23/EEC Low Voltage (LVD) Directive

89/336/EEC Electromagnetic Compatibility Xing (EMC) directive .

EU standards support these commands are:

(1) EN60601-1 Medical Electrical Equipment Part I: General requirements for safety ;

(2) EN60601-1-1 Medical Electrical Equipment Part I: General Requirements for Safety

     and First Amended ;

(3) EN60601-2-11 Medical electrical equipment Part II : γ beam therapy equipment safety

     requirements ;

(4) EN60601-1-2 Medical Electrical Equipment Part I: General Requirements for Safety

     1.2 Parallel standard Electromagnetic compatibility - Requirements and tests.

     The first ( 1 ) , ( 2 ) , ( 3 ) criteria is Gamma Knife Low Voltage (LVD) test based on:

     No. ( 4 ) criteria is Gamma Knife electromagnetic compatibility (EMC) test basis.

In 1995, Japan enacted a new law banning products , the new regulations no longer

follows the principle of error -party liability , and the use of European and North

American practice ( innocent party liability principle ) , the party responsible for product

safety requirements for the product manufacturers, importers Manufacturers ,

distributors and so on.

April 1, 2001 , before the Japanese Electrical Appliance and Material Control Law

(DENTORI) will control the products are divided into A, B two categories, wherein,

A class includes 165 kinds of products , mainly in the power cord, fuses, switches ,

transformers , ballast , etc. ;B class includes 333 kinds of products, mainly lighting,

household appliances , office equipment. Class A products must obtain government

mandatory certification , namely T flag , and the flag is only by MITI ( MITI ) issued .

Class B product conformity shall be made ​​self-proclaimed or apply for third-party

certification , such as TUV Rheinland can mark the S flag .

After 1 April 2001 , Electrical Appliance and Material Safety Law (DENAN) replaces

DENTORI France , while Japan has abolished the T flag , the government no longer

issue certificates directly , but to authorize a third party certification body for product

conformity assessment tests.

New regulations the product is divided into " specific electrical and Materials " and "non-

specific electrical and Materials ." The " specific electrical and Materials " includes a total

of 112 kinds of products ; "non-specific electrical and Materials " includes 340 kinds of

products. To enter the Japanese market, " specific electrical and Materials " products

must obtain third-party certification , labeling PSE ( diamond ) symbol ; "non-specific

electrical and Materials " products shall be made ​​self-proclaimed or apply for third-party

certification , labeling PSE ( Round ) sign.

New law reduced the number of categories of products , more products are classified as

non- classified products " and no longer subject to DENAN constraints, and some

previously classified as "A Class " products are now classified as " specific electrical

and Materials ."

E / eMark detection is the European Common Market, on the steam locomotive spare parts

and security products, noise and emissions, are required to act in accordance with the EU】

【EEC Directives and the Economic Commission for Europe Regulation ECE Regulation】

【requirements through product meets testing requirements, namely to grant a certificate

to ensure traffic safety and environmental protection requirements.

E-Mark detection by testing different country, the number granted is different, for example,

apply to Luxembourg, the E-Mark logo E13/e13.

Applicable product range

Vehicle - that is two or three or more moving motor vehicles, such as passenger cars,

trucks, motorcycles, buses and road vehicles outside the steam locomotive components

- lights and bulbs, a variety of mirrors, tires, wheels, brakes, horn, anti-theft devices, seat

belts, automotive glass and exhaust pipe.

Steam locomotive spare parts - helmets, child safety seats, car electrical products

subsidiary.

Since October 2002, to require all vehicles, vehicle parts, and electronic products for

the car must be enforced EMC testing.

All electronic components sold in Europe must comply with the EMC Directive unified

95/54/EC, the EMC Directive 89/336/EEC the self-declaration is no longer valid. Vehicles

authorized by the EU institutions issued a notice products E / e Mark certification. In other

words, vehicle electronics and electronic components for the original CE (EMC) testing from

October 2002 onwards no longer valid. European countries must re-apply for Department of

Transportation issued E / e Mark certificate for their sales in the European market.

FCC (Federal Communications Commission, the U.S. Federal Communications

Commission ) established in 1934 by COMMUNICATIONACT is an independent U.S.

government agency , directly responsible to Congress . FCC control of radio, television ,

telecommunications, satellite and cable to coordinate domestic and international

communications. Involving the United States more than 50 states, Colombia and the

United States respective districts, to ensure life and property of the radio and wire

communications product safety , FCC 's engineering department (Office of Engineering

and Technology) is responsible for the Commission's technical support, and is

responsible for equipment accreditation matters. Many wireless applications ,

communications products and digital products to enter the U.S. market, require FCC

approval. FCC Commission to investigate and study the various stages of product

safety to find the best way to solve the problem , but FCC also include radios ,

aircraft detection.

According to the relevant parts of the United States Federal Communications Regulations

(CFR 47 part ) stipulates that where electronic products into the United States needs to

be EMC certification ( some of the relevant provisions of the special provisions of the

products ) , one of the more common authentication method , there are three :

Certification, DoC, Verification. These three product certification methods and procedures

are quite different , different products can choose the authentication method in the FCC

with the relevant requirements. Decreasing its certification rigor .

Federal Communications Commission (FCC) ---- managed import and use of radio

frequency devices, including computers, fax machines, electronic devices, radio reception

and transmission equipment, radio controlled toys, telephones, personal computers and

other products that may harm personal safety. If you want to export these products to

the United States, must be authorized by the government of the laboratory according to

FCCtechnical standards for testing and approval. Importers and customs agents to

declare each radio frequency device complies with FCC standards, the FCC license.

For the FCC certification, different products have different each of the three

authentication modes, namely: Verification, Declaration of Conformity (DoC), Certification.

erification is the manufacturers are free to take certain steps to ensure that products

meet appropriate technical standards process.

Declaration of Conformity by the responsible party to take certain steps to ensure that

products meet appropriate technical standards process.

FCC Certification is based on test data and signed application and device approval process.

GS is the meaning of German "Geprufte Sicherheit" (security certified), there are

also "Germany Safety" (German security) mean. GS certification to the German Product

Safety Act (SGS) as the basis, in accordance with the European harmonized standards

or the German industrial standard DIN EN testing of a voluntary certification is recognized

in Europe German safety certification mark.

GS certification mark indicates that the product has passed the safe use of the credibility

of an independent agency of the test. GS certification mark, although not legally required,

but it does in the product malfunctioning caused by accident, so that manufacturers are

subject to strict German (European) product safety laws. So GS certification mark is a

powerful marketing tool that can enhance customer confidence and desire to buy.

Although the GS is a German standard, but most countries in Europe agree. And at the

same time meet the GS certification, the product will meet the requirements of the EC

CE mark. Not the same and CE, GS certification mark does not legally required, but

because of security awareness has penetrated ordinary consumers, an electrical GS

certification mark may be more general in the market more competitive products.

You can apply for GS certified products:

Household appliances, such as refrigerators, washing machines, kitchen

appliances and so on.

Household machinery.

Sports goods.

Home electronics devices, such as audio-visual equipment.

Electrical and electronic office equipment such as copiers, fax machines, shredders,

computers, printers and so on.

Industrial machinery, laboratory measuring equipment. Other security-related products

such as bicycles, helmets, ladders, furniture and so on.

GS certification mark

GS Mark certification can be issued: TUVRH, TUV-SUD, VDE, NEMKO, UL-DEMKO

EU ROHS certification (Restriction of Hazardous Substances Directive) has been scheduled

for July 1, 2006 implementation, since that date, all electrical and electronic equipment sold

in Europe of restricted hazardous substances must comply with the stringent requirements

of Directive .

The Directive stipulates that the European sales of electrical and electronic products, lead

Pb, cadmium Cd, mercury Hg, hexavalent chromium Cr6 +, PBBs PBBs, PBDEs PBDEs

six hazardous substances be restricted after more harmful substances will also be

restrictions.

RoHS certification covers the range of AC1000V, DC1500V following directories listed by the

electronic and electrical products:

Large household appliances: refrigerators, washing machines, microwave ovens,

Lighting: In addition to outside the household fluorescent lighting, lighting controls

air conditioners and other.

Large household appliances: refrigerators, washing machines, micro and small household

appliances: vacuum cleaner, iron, hair dryer, oven, watches and other wave oven,

air conditioning, etc.

IT and telecommunications equipment: computers, fax machines, telephones, cell phones,

etc.

Civilian devices: radios, televisions, video recorders, musical instruments, etc.

Lighting: In addition to outside the household fluorescent lighting, lighting controls

Power Tools: drills, lathes, welding, spray, etc. (to be installed except for large-scale

industrial tools)

Toys / entertainment, sports equipment: electric cars, video game.

Medical Devices: radiation therapy, ECG testing, analysis equipment, etc.

Monitor / control devices: smoke detectors, incubators, plant monitoring and control

machines with.

Which, RoHS Directive currently applicable 8,9 two.

RoHS certification (2002/95/EC) on the maximum allowable concentration of harmful

substances (threshold): Cd threshold of 100ppm; Pb, Hg, Cr6 +, PBB, PBDE threshold

1000ppm; their testing method also requires countries to coordinate.

First, the system certification,: EST electrical products testing laboratory harmful

substances according to the requirements of the EU Directive 2002/95/EC on six kinds

of relevant hazardous substances were detected.

The second is to prepare the listing of components and finished products certification,

namely ROHS integration.

ROHS prohibited chemical substances testing and certification services.

Scientific and technological progress brings convenience, but also increasing waste

electrical and electronic equipment! Developing countries around the world in a positive

environmental regulations did not dare to expect to make harmful substances in the waste

to minimize environmental impact, and requires all manufacturing suppliers assume related

responsibilities.

English is Underwriters Laboratories UL (Underwriter Laboratories Inc.) Shorthand. UL safety

test of America's most authoritative, but also engage in safety testing and identification of

large private institutions. It is an independent, non-profit, do testing for public safety

professional organizations. It uses scientific testing methods to study identified a variety

of materials, devices, products, equipment, construction of life, property damage and

whether the extent of harm; determined to write, issue the appropriate standards and help

reduce and prevent life loss of property information, while carrying out the facts research

business. In short, it is mainly engaged in product safety certification and safety certificate

to operate the business, with the ultimate aim is to market a considerable level of product

safety for human health and property is guaranteed to contribute. Product safety

certification as to eliminate technical barriers to international trade an effective means, UL,

to promote the development of international trade also played an active role.

UL was founded in 1894, the initial phase of UL Fire Lord in the insurance sector by

providing funds to maintain the action until 1916, UL was completely self-sustaining.

After nearly a century of development, UL has become a world-known certification body,

its own set of strict management system of the organization, standards development and

product certification procedures. UL by a security experts, government officials, consumers,

education, utilities, insurance and standards department council composed of

representatives of management and daily work by the president, vice president handling.

Currently, UL has five laboratories in the United States, headquartered in Northbrook town

north of Chicago, while Taiwan and Hong Kong were set up appropriate laboratory.

EU ROHS certification - Restriction of Hazardous Substances Directive.

EU ROHS certification (Restriction of Hazardous Substances Directive) has been scheduled for

July 1, 2006 implementation, since that date, all electrical and electronic equipment sold in Europe

of restricted hazardous substances must comply with the stringent requirements of Directive .

The Directive stipulates that the European sales of electrical and electronic products, lead Pb,

cadmium Cd, mercury Hg, hexavalent chromium Cr6 +, PBBs PBBs, PBDEs PBDEs six hazardous

substances be restricted after more harmful substances will also be restrictions.

RoHS certification covers the range of AC1000V, DC1500V following directories listed by the electronic

and electrical products:

1. A large household appliances: refrigerators, washing machines, microwave ovens,

    air conditioners and other.

2. Small household appliances: vacuum cleaner, iron, hair dryer, oven, watches, etc.

3. IT and telecommunications equipment: computers, fax machines, telephones, cell phones, etc.

4. Civilian devices: radios, televisions, video recorders, musical instruments, etc.

5. Lighting: In addition to household fluorescent lighting outside, lighting control devices.

6. Power tools: drills, lathes, welding, spray, etc. (to be installed except for large-scale industrial tools).

7. Toys / entertainment, sports equipment: electric cars, video game.

8. Medical devices: radiation therapy, ECG testing, analysis equipment, etc.

9. The monitoring / control devices: smoke detectors, incubators, plant monitoring and control machines.

Which, RoHS Directive currently applicable 8,9 two.

RoHS certification (2002/95/EC) on the maximum allowable concentration of harmful substances

(threshold): Cd threshold of 100ppm; Pb, Hg, Cr6 +, PBB, PBDE threshold 1000ppm; their testing

method also requires countries to coordinate.