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Tuesday, July 6, 2010
THE CE MARK
http://www.F2Labs.com
The following steps are involved
STEP 1 : Identify Applicable "DIRECTIVES"
STEP 2 : Identify Applicable "Conformity Assessment Module"
Module 'A' (Internal Production control).
Applicable for products falling under EMC and Low Voltage Directives. Manufacturer's product is tested by a third party. After compliance with the tests, his production process ensures continued conformance. He maintains "Technical Documentation" as a proof of compliance. There is no mandatory involvement of European Lab (i.e. Notified Body).
Modules 'B' to 'H'
Mandatory involvement of European Lab is required which issues "Type Examination Certificate", certifies documentation (called "Technical Construction File" (TCF) and carries out inspections.
STEP 3 : Identify Applicable "Standard"
STEP 4 : Test one sample of the product. Either yourself or from test lab.
STEP 5 : Compile "Technical Documentation"
STEP 6 : Sign the EC "Declaration of Conformity"
STEP 7 : Affix "CE Mark" on the product. Everybody need to check this mark on electrical appliances.
Declaration of Conformity
The CE marking is a mandatory European marking for certain product groups to indicate conformity with the essential requirements set out in European Directives. In order to use the CE mark on a product the manufacturer must draw up a Declaration of Conformity (DoC) in which the manufacturer attests conformity with all relevant New Approach Directives (NADs) and takes sole legal responsibility. In some instances an NAD may require a Notified Body to issue a Certificate of Conformity in order to verify performance of the product or constancy of the production process (Factory Production Control) for example.
The DoC must include: manufacturer's details (name and address etc); essential characteristics the product complies; any European standards and performance data; if relevant the identification number of the Notified Body; and a legally binding signature on behalf of the organization.
Mutual recognition of conformity assessment
There are numerous 'Agreements on Mutual Recognition of Conformity Assessment' between the European Union and other countries such as the USA, Japan, Canada, Australia, New Zealand and Israel. Consequently the CE mark is now found on many products from these countries.
Turkey (which is not a member of the EEA) also requires products to show CE marking as affirmation of conformity.
Dimensions
The CE logo must be at least 5 mm high. The letters "CE" are not enough. The logo must not be modified.
EMC LAB TESTING SERVICES
F-Squared Laboratories can work with you during each phase of your design development - from your prototype phase compliance consulting to final product compliance testing and global approval management.
Our technical staff can work with you at your location for testing and approval management or test your product at our facilities. Feel free to witness your testing at one of our modern EMC facilities.
We are available to provide you with one or all of the following services for your EMC Testing Needs. Also identified below is the F-Squared EMC Testing Services Guide. For more information on the directives and requirements, click the hotlinks.
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Through our Partner Firms which are Nationally Recognized Testing Laboratories (NRTL) and accredited by the Standards Council of Canada (SCC) – we offer you a choice of on-site services.
PERFORMANCE TESTING SERVICES
F-Squared is approved by the US Government to perform product validations testing to the Energy Star requirements.
You may have heard the statement "Know by Test" before. It is how most appliance manufacturers authenticate their marketing claims or measure their product's performance against their competition's like-models.
F-Squared is an independent third party testing laboratory with years of engineering experience in the appliance-testing arena. We will work with you to develop a test program to substantiate your marketing claims, or we can test to recognized industry standards or industry programs such as:
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Why tie up your lab with costly, repetitive test procedures? Why not utilize the testing and engineering experience of F-Squared Laboratories? No test program is too big or too small! We are knowledgeable in testing a variety of both large and small appliances, such as:
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We will work closely with you throughout the testing process to ensure we meet your needs within your time frame. Our commitment to you is prompt, personal, and cost-effective service.
SAFETY TESTING SERVICES
Our safety laboratories are set-up to test/evaluate products for the United States, Canada, Europe, and International Certifications. Our safety facilities are A2LA Accredited, and our safety test data and evaluations are accepted by an OSHA accredited NRTL.
Our experienced team of engineers can develop an efficient plan for addressing your product safety standards and work with you onsite or offsite at our locations.
Design Review
Our engineers offer you product safety testing at the early design and prototype stages of your product development. This work can be done at one of our convenient locations or it can be conducted at your facility. This allows you to be part of the process and provides you with a better understanding of the requirements.
Testing Capabilities
Our technical experts can provide onsite or offsite testing services. We also provide normal or hazardous location testing. F-Squared Laboratories offers you fully equipped testing laboratories that provide a range of product safety testing for North America, Europe (CE, CB, D Mark) and other international standards and marks.
Debugging
At F-Squared Laboratories, not only do we identify the non-compliances found during an evaluation, but we also help you fix the problems. This decreases your turnaround time and gets your products to market in the timeframe that you need.
Documentation Preparation
Once we have completed testing, F-Squared Laboratories can provide you with completed test reports which include test data, photos, construction reviews, supporting documentation, and technical files.
Consulting Services
Our compliance consulting team is ready to help your product each phase of the way from prototype to shipment.
Educational Services
We deliver training on critical compliance information and knowledge transfer to improve efficiencies, save time, and save money on new products.
Field Labeling Services
Our service provides you with on-the-spot testing, evaluation and labeling of your products.
FIELD EVALUATION vs FIELD CERTIFICATION
Field Evaluation
This is a practical and acceptable alternative to traditional product certification. Our service provides you with on-the-spot testing, evaluation and labeling of your products. The testing and evaluation is non-destructive, and is based on published requirements accepted by the Authorities having Jurisdiction (AHJ).
This is a practical and acceptable alternative to traditional product certification. Our service provides you with on-the-spot testing, evaluation and labeling of your products. The testing and evaluation is non-destructive, and is based on published requirements accepted by the Authorities having Jurisdiction (AHJ).
Complying products will be immediately labeled with a distinctive, serialized label per the AHJ requirements. For the U.S., the technical requirements are described in the National Electric Code (NEC) and other applicable requirements specified by the AHJ.
In Canada, the technical requirements are described in the Canadian Electrical Code, CSA Model Code SPE-1000 and for medical/lab/x-ray equipment, the applicable parts of the relevant CSA standards.
When should I choose Field Evaluation?
Choose Field Evaluation if any one or more of the following situations are:
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Field Certification
This is a customized field certification service performed at your location. Products are evaluated to the full requirements of the applicable USA and/or Canadian standards(s). A Certificate of Compliance and a controlled number of serialized labels bearing the NRTL certification mark will be issued for products found compliant to the applicable requirements. Additional labels may be issued upon confirmation that the additional batches are identical to the tested sample(s).
Advantages:
* Faster – Less Expensive – More Convenient – Less Paperwork – No Annual Fees *
When should I choose Field Certification?
Choose Field Certification if in addition to one or more of the above conditions, one or more of the following is also applicable:
You or your customer requires a Certification Mark on the product.
The quantities, although limited, are high and the shipments are repetitive, making this a more cost-effective service.
When should I choose Field Certification over Traditional Certification?
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CLICK FOR MORE INFORMATION
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THE EMC DIRECTIVE
The EMC Directive was adopted in 1989 and then amended in 1992 (92/31/ECC) and 1993 (93/68/EEC). It is regarded as one of the most complex "new approach" directives, as it affects almost all electronic manufacturers and products (including battery-supplied products going to the European Union).
The EMC Directive applies to apparatus, systems, equipment, and installations containing electrical or electronic components.
Definitions
The EMC Directive applies to apparatus, systems, equipment, and installations containing electrical or electronic components.
Definitions
"Apparatus" is defined as a final product with an intrinsic function intended for the final user and intended to be placed on the European Union market as a single commercial unit.
"Equipment" is equivalent to "apparatus."
"System" is defined as several apparatus combined to fulfill a specific function and intended to be placed on the European market as a single functional unit.
"Installation" is defined as several apparatus or systems combined at a given place to fulfill a specific function, and not intended to be placed on the European market as a single functional unit.
"Electromagnetic Compatibility" (EMC) is defined as the combination of electromagnetic emissions and immunity.
An "emission" is defined as electromagnetic energy emitted by a device/product over a power line or through the air.
"Immunity" is defined as the ability of a device/product to not be influenced by the application of electromagnetic energy from external sources.
THE LOW VOLTAGE DIRECTIVE
The Low Voltage Directive (LVD) was adopted in 1973 and has been in effect since 1975. In 1993, it was amended by the Council of the European Communities (93/68/EEC), which rendered it as a "new approach" directive.
The scope of this directive covers "electrical equipment" designed for use with a voltage rating of 50-1000 V AC and 75 - 1500 V DC. However, some countries within the European Union are interpreting the voltage requirements from 0 - 1000 V AC and 0 - 1500 V DC.
THE MACHINERY DIRECTIVE
CE Marking under the Machinery Directive became mandatory as of January 1, 1995. Between the publication of the directive in 1989 and now, the directive has gone through many amendments making it difficult for the manufacturer to determine a single comprehensive set of requirements.
In 1998, the EC introduced directive 98/37/EC, which is a consolidation of the previous directives into one document although it makes no changes whatsoever in the actual requirements.
98/37/EC supersedes and replaces the earlier directives, and this is the number that should be referenced on the declarations and as the citation for the Machinery Directive.
Definitions
For the purpose of this directive, machinery is defined as "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 . . ."
The term "machinery" also covers the "assembly of machines which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole."
THE MEDICAL DEVICES DIRECTIVE
One of the “new approach” directives, the European Union’s Medical Devices Directive has been in effect since January 1, 1995, and enforced since June 15, 1998.
This directive applies to any instrument or apparatus, whether used alone or in combination for the purpose of “diagnosis, prevention, monitoring, treatment, alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap; or, investigation, replacement, or modification of the anatomy. This directive does not apply to active implantable devices or in-vitro diagnostic devices, which are covered under separate directives. It does, however, include computers and software that are used primarily for medical purposes.
The device or apparatus must meet all specified requirements as they relate to performance, health, and safety. The device must not compromise the health and safety of the patient, the user, or any other persons, and risks must be deemed acceptable when considering the benefits to the patient. The product must meet established requirements regarding safety in design, adequate product marking and instructions of use, compatibility with other materials with which it may come in contact, and protection against contamination from a radioactive, infectious, or microbial source. More details regarding these requirements may be found in Annex I of the Medical Devices Directive.
For the purpose of conformity assessment procedures, the directive groups medical devices into four product classes based on the potential risks associated with the device and its intended purpose. Annex IV of the Medical Devices Directive provides greater detail on how to classify the product and the factors that determine that classification. The classifications, however, are as follows:
This directive applies to any instrument or apparatus, whether used alone or in combination for the purpose of “diagnosis, prevention, monitoring, treatment, alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap; or, investigation, replacement, or modification of the anatomy. This directive does not apply to active implantable devices or in-vitro diagnostic devices, which are covered under separate directives. It does, however, include computers and software that are used primarily for medical purposes.
The device or apparatus must meet all specified requirements as they relate to performance, health, and safety. The device must not compromise the health and safety of the patient, the user, or any other persons, and risks must be deemed acceptable when considering the benefits to the patient. The product must meet established requirements regarding safety in design, adequate product marking and instructions of use, compatibility with other materials with which it may come in contact, and protection against contamination from a radioactive, infectious, or microbial source. More details regarding these requirements may be found in Annex I of the Medical Devices Directive.
For the purpose of conformity assessment procedures, the directive groups medical devices into four product classes based on the potential risks associated with the device and its intended purpose. Annex IV of the Medical Devices Directive provides greater detail on how to classify the product and the factors that determine that classification. The classifications, however, are as follows:
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CE MARKING - THE ATEX DIRECTIVE
The ATEX Directive came into effect on a voluntary basis on March 1, 1996. Mandated compliance to this "new approach" directive is required by July 1, 2003 for all products placed on the European market.
Currently, manufacturers still have the choice of complying with either the "new" or old approach requirements until June 30, 2003. In addition, Certificates of Conformity issued under the old approach directive and marked with the Epsilon-x (Ex) will remain valid until June 30, 2003.
Scope of the Directive
Currently, manufacturers still have the choice of complying with either the "new" or old approach requirements until June 30, 2003. In addition, Certificates of Conformity issued under the old approach directive and marked with the Epsilon-x (Ex) will remain valid until June 30, 2003.
Scope of the Directive
This directive covers electrical and mechanical equipment and protective systems, which may be used in potentially explosive atmospheres.
The term "equipment" is defined as "any item which contains or constitutes a potential ignition source and which requires special measures to be incorporated in its design and/or its installation in order to prevent the ignition source from initiating an explosion in the surrounding area."
The term "equipment" also incorporates safety and control devices installed outside the hazardous area but having an explosion protection function.
"Protective Systems" are defined as items that prevent an explosion that has been initiated from spreading or causing damage. These include flame arresters, quenching systems, pressure relief panels, and fast-acting shut-off valves.
The directive explicitly excludes the following types of equipment:
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The ATEX Directive specifies the Essential Health and Safety requirements. The essential requirements must be met by equipment and protective systems intended to be used in potentially explosive atmospheres.
The Essential Safety Requirements (ESR) can be divided basically into three groups:
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Annex II of the ATEX Directive provides a fully detailed list of the ESR.
Depending upon the category of equipment and the ones for which the equipment is intended to be used, the manufacturer might also be required to have a quality system in place, such as ISO 9003 or ISO 10005. More specifics on this issue can be found in the directive.
Equipment covered by the ATEX Directive must also meet the requirements of other relevant directives such as the EMC Directive, Low Voltage Directive, and Machinery Directive.
THE PRESSURE DIRECTIVE
The European Parliament and the European Council adopted the Pressure Equipment Directive in May 1997. As of May 2002, it will become mandatory throughout the European Union. At that time, manufacturers of pressure equipment who want to CE Mark their products will need to comply with the PED as well as the Essential Safety and EMC Directives.
Until that time, manufacturers will have a choice between applying the PED or continuing with the application of existing legislation. The Pressure Equipment Directive has been established for the elimination of technical barriers to trade, and is formulated under the “New Approach to Technical Harmonization and Standards” and to harmonize national laws for the design, manufacture, testing and conformity assessment of pressure equipment.
The Directive is only for use with equipment with a maximum allowable pressure greater than 0.5 bar above atmospheric pressure (i.e., 1.5 bar of absolute pressure).
Under the Community Regime of the Directive, pressure equipment and assemblies above specified pressure and/or volume thresholds must:
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Pressure equipment and assemblies below the specified pressure/volume thresholds must:
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The PED concerns manufacturers of items such as vessels' pressurized storage containers, heat exchangers, steam generators, boilers, industrial piping, safety devices and pressure accessories. These types of items are widely used in process industries such as oil and gas, pharmaceutical, plastics and rubber, food and beverage, glass and paperboard and energy production industries.
The assessment and conformity procedures are different for each category of equipment, ranging from self-certification hazard up to full ISO 9000 Quality Management and/or Notified Body type examination for category IV equipment.
In order to determine how the directive will apply to specific items of pressure equipment, a manufacturer needs to classify his equipment into one of four (I to IV) conformity assessment categories with I being the lowest hazard risk and IV being the highest hazard risk.
THE NOISE DIRECTIVE - 2000/14/EC
Noise in the environment has become a major issue. It has been proven that loud noises at work can cause stress, along with a number of hearing problems including tinnitus and irreversible hearing damage. Due to these concerns, the European Union has published "The Noise Directive", which becomes mandatory on January 3, 2002. This Directive replaces nine current European Directives that presently cover separate machine groups.
The Noise Directive covers only equipment that is marketed or built for use as an entire unit, suitable for its intended utilization. Non-powered attachments that are marketed or utilized separately are excluded, except for hand held concrete-breakers and picks, as well as hydraulic hammers.
The Noise Directive covers only equipment that is marketed or built for use as an entire unit, suitable for its intended utilization. Non-powered attachments that are marketed or utilized separately are excluded, except for hand held concrete-breakers and picks, as well as hydraulic hammers.
The Directive currently applies to 57 types of equipment ranging from large hydraulic excavators to lawn mowers and trimmers. One important element of this new Directive is that, in addition to the CE mark, it will require manufacturers of such equipment to measure the noise emissions and place labels showing the "Guaranteed" noise level of each machine. The Directive also sets noise limits for 22 of the 57 categories, laid down to apply in two stages. As with other European Directives, this Directive requires the same documentation, such as the Declaration of Conformity and Technical File with the appropriate technical information that demonstrates conformity.
Equipment subject to noise limits and noise marking:
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C-TICK - AUSTRALIA AND NEW ZEALAND
The C-Tick Mark is required for electrical/electronic equipment sold in Australia as directed by the Australian Communications Authority (ACA). This requirement became mandatory January 1, 1999.
Effective that same date, New Zealand adopted the Australian EMC framework, thereby forming a Trans-Tasman Compliance Framework. As a result, the C-Tick Mark currently accepted in Australia is now accepted in New Zealand.
FCC - FEDERAL COMMUNICATIONS COMMISSION
The Federal Communications Commission (FCC) requires that all digital devices (including Information Technology, Industrial, Scientific, and Medical Equipment) that operate with internal clock rates over 9 kHz be tested under one or more of the sections outlined in CFR Title 47, Parts 15, 18, 68, and 90. F-Squared Laboratories has filed our test site with the FCC and has been accredited by A2LA in order to provide these services to our customers.
Declaration of Conformity
Declaration of Conformity
In May 1996, the FCC allowed manufacturers of personal computers and peripherals to issue Declarations of Conformity (DoC's) in order to proclaim compliance of their products to Part 15. This was introduced as a way for manufacturers to get their products to market faster. Once the test report has been issued by an accredited test laboratory, the manufacturer can sell products immediately.
Certification
Some products, such as transmitters, are required to be certified by the FCC. Certification requires that an application be made to the FCC. The product may not be sold/marketed until the approval process is completed and the Certification is granted by the FCC. Not only can we do all your testing, but we can act as your agent with the FCC. We will complete the test report and application for you, and provide any follow-up support that is necessary until you receive your certification.
Verification
Verification is a self-approval process. The equipment must be tested and the manufacturer must then maintain the test report and submit it to the FCC upon request. This process is typically used for Class A products such as business computers, TV and FM receivers, and Industrial, Scientific, and Medical Equipment.
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