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Regulatory Agencies and Compliance Requirements

Understanding product safety compliance requirements can be complex and confusing. Here is a brief overview of regulatory agencies, as well as frequently asked questions about North American and European agencies.

Overview of Regulatory Agencies

Mark Agency Concern Geography
UL UL Product Safety–Listed USA
UC UL Product Safety–Classified USA
cUC UL Product Safety–Classified Canada
UR UL Product Safety–Recognized USA
cUL UL Product Safety–Listed Canada
cUR UL Product Safety–Recognized Canada
FCC
Home or Office Use		 FCC - DoC1 RF Emissions2:
  Class B (home)
  Class A (office)		 USA
IC IC - DoC1 RF Emissions:  Class B or A2 Canada
GS TÜV Product Safety
Ergonomics		 Germany
Bauart TÜV Product Safety Germany
CE EU - DoC1 Product Safety
EMC
RF Emissions:  Class B or A2
Immunity		 European Union
VCCI VCCI RF Emissions:  Class B or A2 Japan
C-Tick SMA RF Emissions:  Class B or A2 Australia
New Zealand
TCO99 TCO Product Safety
Emissions2
Immunity
Ergonomics
Energy Savings
Ecology		 Sweden
DHHS 21CFR FDA X-Ray–CRT only USA
MPRII MPR - DoC1 Emission Characteristics: Electric Field & Magnetic Field Sweden
AR/S UL de Argentina Product Safety Argentina

1 DoC - Declaration of Conformity issued by Elo stating compliance with named standards
2 Radio Frequency (RF) Emissions Class B or A - Most Elo models meet the more strict Class B requirements.

FAQs for North America

  • What is the Code of Federal Regulations (CFR)? Answer
  • What is the Federal Communications Commission (FCC)? Answer
  • What equipment does the FCC regulate? Answer
  • Does the FCC regulate computer equipment? Answer
  • Is all computer equipment regulated by the FCC? Answer
  • What is FCC Part 15, Subpart B? Answer
  • What are Class "A" and Class "B" devices? Answer
  • How is FCC compliance verified? Answer
  • How are FCC violations discovered? Answer
  • What are the penalties for selling equipment that does not comply with FCC regulations? Answer
  • What is the Underwriters Laboratory (UL)? Answer
  • What are UL standards and why are products tested to these standards? Answer
  • What is UL 2601-1? Answer
  • What is UL 60950? Answer
  • How is U.S. product safety compliance verified? Answer
  • What is the Canadian Standards Association (CSA)? Answer
  • What is the cUL mark? Answer
  • What is CSA 22.2 No. 601.1? Answer
  • What is CSA 22.2 No. 60950? Answer
  • Which mark is better-CSA or cUL? Answer
  • What is IPX1 or IEC529/IPX1? Answer
What is the Code of Federal Regulations (CFR)?
The Code of Federal Regulations (CFR) is a compilation of regulations issued by federal departments. Title 47 (47 CFR) is the Federal Communications Commission (FCC) regulations, Title 21 is the Department of Health and Human Services (DHHS) regulations, and Title 29 is the Department of Labor regulations.
What is the Federal Communications Commission (FCC)?
The Federal Communications Commission (FCC) is the U.S. government agency that regulates and enforces the use of radio transmission frequencies.
What equipment does the FCC regulate?
The FCC regulates the use of any equipment which might intentionally or unintentionally cause radio frequency (RF) signals (radiators). It assigns frequencies and sets limits on the strength of RF signals.
Does the FCC regulate computer equipment?
Yes. High-speed circuits in computers and computer peripherals can sometimes cause both to emit unacceptable RF signal levels.
Is all computer equipment regulated by the FCC?
No. Computing devices used in: (1) transportation equipment; (2) industrial, commercial, and medical test equipment; (3) specialized medical computing devices (such as CT and MRI scanners); (4) appliances (such as microwave ovens and dishwashers); and (5) control of power systems utilized by public utilities are exempt from FCC regulation.
What is FCC Part 15, Subpart B?
FCC Part 15, Subpart B (47 CFR Part 15, Subpart B) is the section of FCC regulations that "sets out the regulations under which an intentional, unintentional, or incidental radiator may be operated." It defines digital devices, including peripheral devices, as unintentional radiators which are therefore subject to regulation.
What are Class "A" and Class "B" devices?
Equipment used in commercial settings is considered Class "A". Class "B" digital devices are those intended for use in the home. FCC limits for RF radiation differ depending on the application of the digital device. The test distances for RF radiation are approximately three times closer for Class "B" than Class "A".
How is FCC compliance verified?
FCC-certified labs test and provide data to verify compliance with FCC regulations. Manufacturers must mark their product to indicate compliance with the relevant section(s). Once tested, a product may not be altered in any way that would invalidate the results.
How are FCC violations discovered?
End user complains of equipment interference. Competitor complains of unfair product claims. Trade show audits
What are the penalties for selling equipment that does not comply with FCC regulations?
Three levels of action (Marketing Citation, Notice of Apparent Liability, and Public Notice) can be levied. Criminal penalties can also be administered.
What is the Underwriters Laboratory (UL)?
The Underwriters Laboratory (UL) is a private company that drafts standards for use in certifying product safety in the U.S. UL also tests products to verify compliance with those standards.
What are UL standards and why are products tested to these standards?
The U.S. Department of Labor's Occupational Safety and Health Administration (OSHA) regulations require all electrical equipment used in industrial settings be approved to product safety standards. "Approved" means tested and verified to generally accepted UL or American National Standards Institute (ANSI) testing standards.
What is UL 2601-1?
UL 2601-1 is entitled "Medical Electrical Equipment - Part 1: General Requirements For Safety." It is a standard written by Underwriters Laboratories (UL) harmonized to the international standard IEC 60601-1 with the same title.
What is UL 60950?
UL 60950 is entitled "Safety of Information Technology Equipment, Including Electrical Business Equipment." It is a standard written by Underwriters Laboratories (UL) harmonized to the international standard IEC 60950 with the same title. This is a bi-national standard with CSA.
How is U.S. product safety compliance verified?
Any approved Nationally Recognized Testing Laboratory (NRTL) may verify compliance to approved product safety standards and allow use of its agency mark to indicate compliance. UL is one NRTL, others include ETL, FM, and MET. Once verified, a product may not be altered in any way that would invalidate the approved configuration.
What is the Canadian Standards Association (CSA)?
The Canadian Standards Association (CSA) is a private company that drafts standards for use in certifying product safety., The standards must be accepted by the Standards Council of Canada (SCC) in order to become a national standard of Canada. CSA also tests products to verify compliance with those standards.
What is the cUL mark?
The cUL mark is Underwriters Laboratory's mark indicating compliance with Canadian product safety standards.
What is CSA 22.2 No. 601.1?
CSA 22.2 No. 601-1 is entitled "Medical Electrical Equipment - Part 1: General Requirements For Safety." This standard is written by Canadian Standards Association (CSA) and is harmonized to the international standard IEC 60601-1 with the same title.
What is CSA 22.2 No. 60950?
CSA 22.2 No. 60950 is entitled "Safety of Information Technology Equipment, Including Electrical Business Equipment." This standard is written by Canadian Standards Association (CSA) harmonized to the international standard IEC 60950 with the same title. This is a bi-national standard with UL.
Which mark is better-CSA or cUL?
Neither. Both agencies are accredited by the SCC and have reciprocal agreements for the acceptance of test results. Therefore both marks indicate compliance with Canadian product safety standards. The advantage of UL is the ability to obtain U.S. and Canadian compliance with one submittal.
What is IPX1 or IEC529/IPX1?
IEC529 and the most recent IEC60529 is an international standard that describes a system to classify the degrees of protection provided by enclosures of electronic equipment. IPX1 indicates tested safety from vertically dripping water. For a medical product IPX1 indicates DRIP-PROOF, a higher than ORDINARY level of protection from drips, leaks, and spills.

FAQs for Europe

  • What is the European Union (EU)? Answer
  • What is a European Directive? Answer
  • What is the Low Voltage Directive (LVD)? Answer
  • What is the EMC Directive? Answer
  • What is the Medical Device Directive (MDD)? Answer
  • How do you verify compliance with an EU Directive? Answer
  • What are relevant European standards? Answer
  • What is IEC 60601-1? Answer
  • What is IEC 60601-1-2? Answer
  • What is EN 60601-1? Answer
  • What is EN 60601-1-2? Answer
  • What is EN 60950? Answer
  • What is EN 55022? Answer
  • What is EN 55011? Answer
  • What is the consequence of not complying with EU Directives? Answer
  • What is a Notified Body? Answer
  • Does it make any difference what Notified Body you use? Answer
  • What is TÜV? Answer
  • What is the significance of the GS mark? Answer
  • What is the TÜV/Bauart mark? Answer
  • What is the CE mark? Answer
  • What is IPX1 or IEC529/IPX1? Answer
What is the European Union (EU)?
The European Union (EU) is a family of democratic European countries joined together to promote economic unity among members. The EU was formerly known as the Common Market and has removal of technical trade barriers as a key goal.
What is a European Directive?
A European Directive is a regulation imposed by the European Union, which supersedes the regulations of the member states.
What is the Low Voltage Directive (LVD)?
The LVD (73/23/EEC) defines mechanical and electrical protection requirements relating to the safe use of electrical equipment operating between 50 and 1000 VAC, and between 75 and 1500 VDC.
What is the EMC Directive?
The EMC Directive (86/361/EEC) defines protection requirements relating to electromagnetic compatibility.  Conformance" which accompanies the product packing information. The Directive may or may not require verification by a Notified Body. The LVD, EMC and MDD Directives permit products to indicate conformity by the CE mark. MDD products may also require a Notified Body mark.
What is the Medical Device Directive (MDD)?
The European Union's Medical Device Directive (93/42/EEC) defines requirements relating medical devices and their accessories.
How do you verify compliance with an EU Directive?
Most directives only state the "essential requirements" of the regulation and refer to the use of "relevant standards". Relevant standards are those generally accepted technical standards that specify how to test products to verify compliance. An EU "Notified Body" uses the applicable relevant standards to perform the tests. Upon successful completion of the tests, the Notified Body may grant permission to the manufacturer to use the Notified Body's mark on its product. Once tested, a product may not be altered in any way that would invalidate the results.
What are relevant European standards?
These are standards developed or adopted by The International Electrotechnical Commission (IEC), the European Committee for the Electrotechnical Standardization (CENELEC), and the International Special Committee on Radio Interference (CISPR) (subcommittee of the IEC). Standards of other European organizations may be used as the relevant standards when performing regulatory compliance testing for the EU.
What is IEC 60601-1?
IEC 60601-1 is entitled "Medical Electrical Equipment - Part 1: General Requirements For Safety." This standard written by the International Electrotechnical Commission (IEC) is the general electrical safety standard for medical electrical products worldwide.
What is IEC 60601-1-2?
IEC 60601-1-2 is entitled "Medical Electrical Equipment - Part 1-2: General Requirements For Safety - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests." This standard written by the International Electrotechnical Commission (IEC) is the EMC standard applied to medical electrical equipment sold products worldwide.
What is EN 60601-1?
EN 60601-1 is entitled "Medical Electrical Equipment - Part 1: General Requirements For Safety". This standard written by the European Union (EU) is harmonized to the international standard IEC 60601-1 with the same title, and is the general electrical safety standard for medical electrical product sold within the European Union.
What is EN 60601-1-2?
IEC 60601-1-2 is entitled "Medical Electrical Equipment - Part 1-2: General Requirements For Safety - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests." This standard written by the European Union (EU) is the EMC standard applied to medical electrical equipment sold within the European Union and is harmonized to the international standard IEC 60601-2 with the same title.
What is EN 60950?
EN 60950 is entitled "Safety Of Information Technology Equipment, Including Electrical Business Equipment". It is a CENELEC-approved standard and is published as one of many relevant standards for the Low Voltage Directive. Prior to adoption by CENELEC, it was published as an IEC standard and referenced as IEC 950.
What is EN 55022?
EN 55022 is entitled "Emission Limits for Information Technology Equipment" (ITE). It is a CENELEC-approved standard and is published as one of many relevant standards for the EMC Directive. Prior to adoption by CELELEC, it was published as a CISPR standard and referenced as CISPR 22.
What is EN 55011?
EN 55011 is entitled "Limits and Methods of Measurement of Radio Disturbance Characteristics of ISM Radio-Frequency Equipment". It sets the emission limits for industrial, scientific, and medical RF equipment. EN 55011 is a CENELEC-approved standard and is published as one of many relevant standards for the EMC Directive. Prior to adoption by CENELEC, it was published as a CISPR standard and referenced as CISPR 11.
What is the consequence of not complying with EU Directives?
The consequence of not complying with the EU Directives is denial of product entry into any EU country.
What is a Notified Body?
A Notified Body is a testing agency authorized by the EU to verify compliance with (a) specific Directive(s). Directives may refer to the agency as a Notified Lab, Competent Body, or Authorized Body.
Does it make any difference what Notified Body you use?
No, provided the testing agency is notified for the Directives for which the product is being tested. The reputation and quality of the agency may, however, have an impact on the end customer.
What is TÜV?
There are many TÜV German product testing agencies, many of which are Notified Bodies for many EU directives. They verify compliance with EU directives and German regulatory requirements by testing to the relevant standards.
What is the significance of the GS mark?
The GS mark indicates product is compliant with German regulatory requirements. It may also indicate additional compliance with other standards. The GS mark is used only with complete end-products, such as desktop monitors.
What is the TÜV/Bauart mark?
The TÜV/Bauart mark is the TÜV testing agency mark which indicates a component product has been tested to comply with all applicable European standards. This applies to sub-assemblies such as kiosk and frame monitors, and components such as controllers and screens.
What is the CE mark?
For those EU Directives that permit it, the CE mark indicates product compliance with standards indicated in the "Certificate of Conformance" which accompanies the product packing information. The Directive may or may not require verification by a Notified Body. The LVD, EMC and MDD Directives permit products to indicate conformity by the CE mark. MDD products may also require a Notified Body mark.
What is IPX1 or IEC529/IPX1?
IEC529 and the most recent IEC60529 is an international standard that describes a system to classify the degrees of protection provided by enclosures of electronic equipment. IPX1 indicates tested safety from vertically dripping water. For a medical product IPX1 indicates DRIP-PROOF, a higher than ORDINARY level of protection from drips, leaks, and spills.