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
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.
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)
| Product | Standard |
| Digital Apparatus (ITE) | ICES-003* |
| Industrial, Scientific, & Medical Equipment (ISM) | ICES-001* |
| Radio Frequency Lighting Devices |
ICES-005 |
| 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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