Henry Ott Consultants

Electromagnetic Compatibility Consulting and Training




European Union

United States

Australian EMC Requirements Handbook

Since January 1, 1999 many products (such as ITE, ISM equipment, & household appliances) have been required to meet Australian EMC requirements.  Presently Australia has only mandatory emission requirements, immunity requirements are not mandatory.   The Australian Communications Authority (ACA) has just released a new revised Electromagnetic Compatibility Handbook (December 1999 edition) to help manufacturers, importers, and suppliers to understand and interpret the requirements.  To assure compliance with the EMC regulations, suppliers must satisfy four basic requirements.  They are: (1) establish sound technical grounds for product compliance, (2) make and hold a Declaration of Conformity, (3) prepare and keep compliance records, and (4) label the product. The signed Declaration of Conformity must be held in Australia by the supplier placing the product on the Australian market.  Compliance records (such as test reports etc.) upon which the Declaration of Conformities based do not have to be kept in Australia.  However, the compliance records must be made available, for audit or investigation purposes, within ten working days of written notice issued by the Australia Communications Authority.   Copies of all compliance records must be kept forgive years after the product ceases to be offered for sale in Australia.  The joint Australian/New Zealand EMC Standards are based upon the international CISPR Standards.  Click here for a cross reference between Australian and the equivalent international CISPR standards. The Electromagnetic Compatibility  Handbook Table of Contents is listed below: The 1999 handbook was revised and updated in 2003. The 2003 handbook however is now obsolete and has not as yet been replaced.

Information on EMC Compliance and Labeling can be found in:   http://acbcert.com/documents/misc-docs/australian-emc-requirements.pdf.

The Australian Communications Authority web page is at www.acma.gov.au.

European Union EMC

Generic Immunity Standards

Industrial Enviroments: Effective June 1, 2008 a new standard  EN 61000-6-2: 2005 will replace EN 61000-6-2:2001 as the Generic Immunity Standard for electronic equipment used in industrial environments. 

Residential/Commercial Enviroments: Effective December 1, 2009 a new standard  EN 61000-6-1: 2007 will replace EN 61000-6-1:2001 as the Generic Immunity Standard for electronic equipment used in residential/commercial environments.

RF Immunity Testing Above 1 GHz: Both of these new generic immunity standards  require radiated immunity testing up to 2.7 GHz at the following levels above 1 GHz.

    1,000 to 1,400 MHz:    Not Required
    1,400 to 2,000 MHz:    3 V/m
    2,000 to 2,700 MHz:    1 V/m

New EMC Directive (2014/30/EU)

A new updated version of the ten year old EMC Directive (2004/108/EC) was published in the  Official Journal of the European Communities on March 29, 2014 as Directive 2014/30/EU.  The new directives essential requirements (ANNEX I) remain the same, however, most other aspects of the directive have been completely rewritten.

The new directive becomes effective as of April 18, 2014, however, a transition period allows products that are compliant with the old directive to be marketed until April 20, 2016 at which time the old directive (2004/108/EC) is repealed.

The new directive can be viewed at http://old.eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2014:096:0079:0106:EN:PDF

Revised EMC Directive Standards List

 An updated list of harmonized standards under  the new EMC directive 2004/108/EC (previously 89/336/EMC) along with their effective dates was published in the Official Journal the European Communities (OJ) on January 16,  2015.  The list replaces all previous  lists  published in the OJ.  The list is available at: http://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:52015XC0116(03)&from=EN

Guideline on the Application of the EMC Directive

In 1997 the European Commission in partnership with industry and national authorities published Guidelines on The Application of Council Directive 89/336/EEC of 3 May 1989 on the Approximation of the Laws of the Member States Relating to Electromagnetic Compatibility. This document is intended to assist interested parties in the understanding and in the application of the EMC Directive. Although the document has no legal standing, it is very helpful in understanding the application of the EMC Directive to apparatus, systems, components, installations, second hand apparatus, repaired apparatue, and spare parts. This guideline was revised on February 8, 2010 and can be viewed at: http://ec.europa.eu/enterprise/sectors/electrical/files/emc_guide__updated_20100208_v3_en.pdf

Medical Equipment Directive (93/42/EEC)

In the European Union Medical Equipment is covered by the Medical Equipment Directive 93/42/EEC, not the EMC Directive. The directive was published on June 14, 1993 and can be viewed at:


Compliance Procedures and Labeling (Declaration of Conformity)

ce mark "CE" stands for European Conformity (Conformité Européene in French) and indicates that the product complies with all the applicable New Approach Directives applying to it.

Additional Useful Information

Information on all the European Union's New Approach Directives and Standards can be obtained on: http://www.newapproach.org/Directives/Default.asp

U.S. EMC Regulations 

FCC EMC Regulations

The majority of the U.S. EMC regulations are contained in the Federal Communications Commission (FCC) Rules.  The table below lists the specific Parts of the FCC Rules that are applicable to various types of products.
Product FCC Rules
Information Technology Equipment (ITE) Part 15, Radio Frequency Devices, Subpart B, Unintentional Radiators
Industrial, Scientific, & Medical Equipment (ISM) Part 18, Industrial Scientific & Medical Equipment
Terminal Equipment Connected to the Telephone Network Part 68, Connection of Terminal Equipment  to the Telephone Network*
Central Office Telecommunications Equipment GR-1089, EMC and Electrical Safety -- Generic Criteria for Network Telecommunications Equipment**
Medical Equipment Exempt from FCC Rules, Controlled by Food & Drug Administration (FDA).  See section below on Medical Equipment.
Industrial Process Control Equipment Exempt [Section 15.103(b)]
Test Equipment Exempt [Section 15.103(c)]

* Part 68 of the FCC rules is not an EMC regulation but deals with avoiding harm to the telephone network.  Terminal equipment connected to the telephone network must meet both Parts 15 and 68 of the Rules.

** These are Telecordia (formally Bellcore, formally AT&T) standards for equipment installed in telephone central offices.  They are often refereed to as NEBS (Network Equipment Building Standards) documents. In addition telecommunications central office equipment must meet GR-63 which covers the physical properties of equipment such as heat dissipation, temperature and humidity, earthquake and shock and vibration, etc.

The FCC Rules are codified as Title 47 Telecommunications   of the Code of Federal Regulations (CFR).

For example, therefore, the EMC regulations for ISM equipment are contained in the Code of Federal Regulations, Title 47, Part 18.

To access the CFR click on the link above, then scroll down to the bottom of the page and select Title 47 - Telecommunications.  When the Title 47 page is displayed, select the range of the rules (e.g. Parts 0-19) that include the appropriate part for your product.  When the third page displays, select the specific part of the rules that is correct for your product.

Note that the CFR is revised once a year.  For Title 47, this revision occurs in the early spring of the year.  The cutoff date, however, for inclusion in the revision is October 1 of the previous year. Therefore, any changes made after October 1 will not appear in the next revision.  The CFR, therefore, can be from six months to eighteen months out of date.

Code of Federal Regulations, Title 47

The following table lists the more important sections of the FCC EMC Regulations, Parts 2 and 15, with links to the text of each section in the Code of Federal Regulations.

    Table of FCC EMC Regulations CFR Title 47. Parts 2 and 15.

Additional Useful Documents

The way a regulation (or revision to a regulation) is made public in the United States is by publication in the Federal Register.  The Federal Register is published every business day of the year and includes material from all of the federal regulatory agencies.  If it is published in the Federal Register,  it's official and you are presumed to know about it!

Another useful, but unofficial document, is the FCC's Daily Digest.  The Daily Digest provides a brief synopsis of Commission orders, news releases, and public notices, and all other FCC documents released on that business day.  A new ruling will, therefore, be first listed in the Daily Digest, than subsequently published in the Federal Register.

Still another source of useful information is the FCC Web Site.

Medical Equipment

The Food and Drug Administration (FDA) regulates medical equipment.  Although the FDA  developed EMC standards, as early as 1979, they have never adopted them as mandatory.  Rather they depend on their reviewers guideline to assure that medical devices are properly designed to be immune to EMI.  This document "Guide to Inspections of Electromagnetic Compatibility Aspects of Medical Devices Quality Systems," states the following:  "At this time the FDA does not require conformance to any EMC standards.  However, EMC should be addressed during the design of new devices, or redesign of existing devices." For more information see GUIDE TO INSPECTIONS OF ELECTROMAGNETIC COMPATIBILITY ASPECTS OF MEDICAL DEVICE QUALITY SYSTEMS.

The FDA, however, is becoming increasingly concerned about the EMC aspects of medical devices, and inspectors are requiring assurance from manufacturers that they have addressed EMC concerns during the design process, and that the device will operate properly in its intended electromagnetic environment.  The above mentioned Guide encourages manufacturers to use IEC 60601-1-2 Medical Equipment, Electromagnetic Compatibility Requirements and Tests (formally ICE 601-1-2) as their EMC standard.  IEC 60601-1-2 provides limits for both emission and immunity, including transient immunity such as ESD.

As a result, in most cases, IEC 60601-1-2 has effectively become the unofficial, de facto, EMC standard that  has to be met for medical equipment.

Additional EMC Standards of Interest

Automotive Electronics: SAE J551 is a vehicle level EMC Standard, and SAE J1113 which is a component level EMC standard. (SAE stands for Society of Automotive Engineers)

Military Equipment:  MIL-STD-461 which covers both emission and susceptibility. The latest version is MIL-STD-461F whichwas released on

Avionics:  RTCA-DO-160 which is similar to MIL-STD-461 but focuses on commercial avionics. (RTCA was organized in 1935 as the Radio Technical Commission for Aeronautics)

Canadian EMC Regulations

The Canadian EMC regulations are similar to those of the United States.  The Canadian EMC Regulations are controlled by Industry Canada.  The table below lists the Canadian EMC standards that are applicable to various types of products.


Product Standard
Digital Apparatus (ITE) ICES-003*
Industrial, Scientific, & Medical Equipment (ISM) ICES-001*
Radio Frequency Lighting Devices
Terminal Equipment Connected to the Telephone Network* CS-03**
Medical Equipment Exempt
Industrial Process Control Equipment Exempt
Test Equipment Exempt

*These standards can be accessed from the Industry Canada web page listed above,  they are under STANDARDS/Interference Causing Equipment Standards.
**This standard can be accessed from the Industry Canada web page listed above,  it is under STANDARDS/Terminal Equipment - Technical Specifications List.

Also available on the Industry Canada web page are a series of Electromagnetic Compatibility Advisory Bulletins (EMCAB).  One particularly applicable bulletin is EMCAB-3 -  Implementation and Interpretation of the Interference-Causing Equipment Standard for Digital Apparatus, ICES-003 .

The Canadian equivalent of the US Federal Register is the Canada Gazette .

Mutual Recognition Agreement

The United States and Canada have a Mutual Recognition Agreement whereby each country  agrees to accept test reports from the other country for equipment authorization.

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Henry Ott Consultants
48 Baker Road Livingston, NJ 07039
Phone: 973-992-1793,   FAX: 973-533-1442

May 27, 2016 (hwo)