Regulatory Agencies and Compliance Requirements

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.

The Federal Communications Commission (FCC) is the U.S. government agency that regulates and enforces the use of radio transmission frequencies.

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.

Yes. High-speed circuits in computers and computer peripherals can sometimes cause both to emit unacceptable RF signal levels.

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.

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.

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".

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.

End user complains of equipment interference. Competitor complains of unfair product claims. Trade show audits

Three levels of action (Marketing Citation, Notice of Apparent Liability, and Public Notice) can be levied. Criminal penalties can also be administered.

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.

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.

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.

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.

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.

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.

The cUL mark is Underwriters Laboratory's mark indicating compliance with Canadian product safety standards.

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.

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.

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.

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.

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.

A European Directive is a regulation imposed by the European Union, which supersedes the regulations of the member states.

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.

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.

The European Union's Medical Device Directive (93/42/EEC) defines requirements relating medical devices and their accessories.

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.

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.

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.

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.

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.

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.

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.

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.

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.

The consequence of not complying with the EU Directives is denial of product entry into any EU country.

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.

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.

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.

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.

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.

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.

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.