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.
“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.
Low Voltage Directive (72/23/EEC)
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 (98/37/EC)
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.
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 – 93/42/EEC
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:
CE Marking – 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
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:
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:
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 Equipment Directive 97/23/EC
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:
Pressure equipment and assemblies below the specified pressure/volume thresholds must:
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 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:
Australia/New Zealand (C-TICK)
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.
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. F2 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
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.
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 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.
US and Canadian Safety
F2 Laboratories is a full service testing organization. If your products need US and Canadian safety approvals, you may be faced with the concern over which mark do you use and what mark is accepted in the field. There are many myths that your choices are limited to certain marks issued by UL, CSA, FM, ETL, AGA, or CGA.
Setting the Record Straight
To sell your product in the United States, a laboratory that is accredited by OSHA as a Nationally Recognized Testing Laboratory (NRTL) can and should evaluate it. When your product bears a Mark from an NRTL, you are telling the Authorities having Jurisdiction (AHJ)and consumers that it complies with the applicable requirements set by ANSI, ASTM, NEMA, and UL standards.
Likewise, when you sell your product in Canada, the law requires that you have it approved by a Certification Organization (CO) accredited by the Standards Council of Canada (SCC). Once your product is evaluated against the applicable Canadian requirements, it will bear a mark specifically designated for Canada.
The Industry Canada requires that most digital devices that operate over 10 kHz be tested under ICES-003. F2 Laboratories can expedite your Industry Canada Approvals when you have your FCC testing done concurrently. Although the requirements for the Industry Canada are not identical to those of the US, many of the technical requirements are nearly the same. We can complete all the necessary paperwork to ensure your compliance in Canada.
Verification is a self-approval process required for all equipment that falls under the scope for Canada’s Interference Causing Equipment Standards (ICES). The manufacturer or importer is responsible for compliance and must maintain compliance records for at least 5 years.
Some products require “certification.” A certification application must be made to the Industry Canada for these products. F2 Laboratories can act as your agent with the Industry Canada, as well.
Total Equality – The CB Scheme
The CB Scheme (in which “CB” refers to “Certification Body”) is an international program developed by the International Electrotechnical Commission (IEC) through their program entitled the IEC System for Conformity Testing to Standards for Safety of Electrical Equipment (IECEE). The CB Scheme provides and allows for an exchange of test reports among the participating countries’ laboratories and certification organizations, which are referred to as National Certification Bodies (NCBs). Each of the participating countries’ NCB has been accredited by the IECEE.
Those countries involved in the program include:
How Does it Work?
A manufacturer applies to any of the participating NCBs for a CB Test Certificate. The NCB will perform complete testing and evaluation of the manufacturer’s product to determine conformity with the appropriate standard accepted in the Scheme. If the product is found to be in compliance with the standard, the NCB will issue a CB Test Report and CB Test Certificate.
These documents may then be presented to other participating NCBs for those nations from which the manufacturer may need additional certifications. Upon evaluation of the test documents, the other NCBs may determine that the results are sufficient to grant national certification without performing additional tests. Thus, the CB Scheme offers the manufacturer an efficient way of having product investigated to the appropriate IEC standards and to the National Deviations of participating countries in which the product is intended for market.
A CB Test Report can also be used to support your self-declaration towards the CE Marking, which is mandatory in countries of the European Union.
What Standards are Accepted in the CB Scheme?
The standards used are the various internationally recognized IEC standards for electrical equipment. The CB Scheme, however, permits each country to have some National Deviations to address local safety concerns.
The United States and its NCBs currently participate in the CB Scheme for the following categories:
Compliance with National Deviations may be evaluated by either the NCB issuing the CB Certificate and CB Test Report or by the NCB to whom the test documents are presented for recognition and acceptance.
It may help further reduce costs, completion time, sample requirements, and project complexity by having all appropriate National Deviations evaluated by the NCB who issues the CB Test Certificate and CB Test Report.