|
| Q: |
What is
the Code of Federal Regulations
(CFR)? |
| A: |
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. |
|
| Q: |
What is
the Federal Communications
Commission (FCC)? |
| A: |
The Federal
Communications Commission (FCC)
is the U.S. government agency
that regulates and enforces the
use of radio transmission
frequencies. |
|
| Q: |
What
equipment does the FCC regulate? |
| A: |
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.
|
|
| Q: |
Does
the FCC regulate computer
equipment? |
| A: |
Yes. High-speed
circuits in computers and
computer peripherals can
sometimes cause both to emit
unacceptable RF signal levels.
|
|
| Q: |
Is all
computer equipment regulated by
the FCC? |
| A: |
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. |
|
| Q: |
What is
FCC Part 15, Subpart B? |
| A: |
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. |
|
| Q: |
What
are Class "A" and Class "B"
devices? |
| A: |
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". |
|
| Q: |
How is
FCC compliance verified? |
| 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. |
|
| Q: |
How are
FCC violations discovered? |
| A: |
End user
complains of equipment
interference. Competitor
complains of unfair product
claims. Trade show audits |
|
| Q: |
What
are the penalties for selling
equipment that does not comply
with FCC regulations? |
| A: |
Three levels of
action (Marketing Citation,
Notice of Apparent Liability,
and Public Notice) can be
levied. Criminal penalties can
also be administered. |
|
| Q: |
What is
the Underwriters Laboratory
(UL)? |
| A: |
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.
|
|
| Q: |
What
are UL standards and why are
products tested to these
standards? |
| A: |
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. |
|
| Q: |
What is
UL 2601-1? |
| A: |
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. |
|
| Q: |
What is
UL 60950? |
| A: |
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. |
|
| Q: |
How is
U.S. product safety compliance
verified? |
| A: |
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. |
|
| Q: |
What is
the Canadian Standards
Association (CSA)? |
| A: |
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.
|
|
| Q: |
What is
the cUL mark? |
| A: |
The cUL mark is
Underwriters Laboratory's mark
indicating compliance with
Canadian product safety
standards. |
|
| Q: |
What is
CSA 22.2 No. 601.1? |
| A: |
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. |
|
| Q: |
What is
CSA 22.2 No. 60950? |
| A: |
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.
|
|
| Q: |
Which
mark is better-CSA or cUL? |
| A: |
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.
|
|
| Q: |
What is
IPX1 or IEC529/IPX1? |
| A: |
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.
|
|
| Q: |
What is the European
Union (EU)? |
| A: |
The European Union (EU)
consists of 15 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. |
|
| Q: |
What is a European
Directive? |
| A: |
A European Directive is a
regulation imposed by the
European Union, which supersedes
the regulations of the member
states. |
|
| Q: |
What is the Low
Voltage Directive (LVD)? |
| A: |
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. |
|
| Q: |
What is the EMC
Directive? |
| A: |
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.
|
|
| Q: |
What is the Medical
Device Directive (MDD)? |
| A: |
The European Union's Medical
Device Directive (93/42/EEC)
defines requirements relating
medical devices and their
accessories. |
|
| Q: |
How do you verify
compliance with an EU Directive? |
| A: |
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. |
|
| Q: |
What are relevant
European standards? |
| A: |
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. |
|
| Q: |
What is IEC 60601-1? |
| A: |
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.
|
|
| Q: |
What is IEC
60601-1-2? |
| A: |
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. |
|
| Q: |
What is EN 60601-1? |
| A: |
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. |
|
| Q: |
What is EN
60601-1-2? |
| A: |
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. |
|
| Q: |
What is EN 60950? |
| A: |
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. |
|
| Q: |
What is EN 55022? |
| A: |
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. |
|
| Q: |
What is EN 55011? |
| A: |
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. |
|
| Q: |
What is the
consequence of not complying
with EU Directives? |
| A: |
The consequence of not
complying with the EU Directives
is denial of product entry into
any EU country. |
|
| Q: |
What is a Notified
Body? |
| A: |
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. |
|
| Q: |
Does it make any
difference what Notified Body
you use? |
| A: |
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. |
|
| Q: |
What is TÜV? |
| A: |
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. |
|
| Q: |
What is the
significance of the GS mark? |
| A: |
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.
|
|
| Q: |
What is the TÜV/Bauart
mark? |
| A: |
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.
|
|
| Q: |
What is the CE mark? |
| A: |
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. |
