Q & A
What is "Medical Device CE certification" certification?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
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
(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.
What is PSE certification?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 ."
What is E-MARK certification?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
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.
What is FCC certification?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 ,
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.
What is GS certification?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.
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
What is ROHS certification?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
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,
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
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
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
What is UL certification?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.
What is ROHS certification?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.
What is CE certification?What is CE certification?
CE is written in French, English meaning "European Conformity the European Community.
"CE" is the French "Conformit é Europ é ene" acronym, meaning "in line with European (standard)."
"CE Marking", namely the CE mark, European Union, signed in 1993 Products Directive 98/68/EEC
was formally proposed, CE mark to become the EU unified compulsory product certification mark.
In other words, there is no CE mark, it can not enter the EU market.
Apply the CE mark signifies that the manufacturer declares: This product complies with European
health, safety, environmental and consumer protection laws and other relevant provisions of the basic
requirements (in practice, these laws make more directive approach to product release) . CE mark is
applied to products that can legally enter the EU single market and free circulation within the EU
European Economic Area, the European Union, the European Free Trade Association countries
(except Switzerland). Before the implementation of the CE mark, the EC countries on imports and
sales requirements are different, it is easy to form barriers to trade between them, hindering economic
integration process. In accordance with the EC May 7, 1985 in (85/C136/01) number "technical
coordination and standards for new methods of resolution" (New Approach Directives), CE mark
came into being.
EU technical information:
1 voltage is 230V / 50Hz.
2 plugs are Class I and Class II two kinds.
Q & A