CDI Conversion Devices, INC. World Class Medical Supplies
Medical Power Solutions


Overview of Regulatory Agencies


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

Notes:

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.

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 vs. UL….Both agencies are accredited 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.

Class A vs. B…..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".

A CB Scheme is the international system for acceptance of test reports dealing with the safety of electrical and electronic products. It is a multilateral agreement among participating countries and certification organizations. A manufacturer utilizing a CB test report issued by one of these organizations can obtain national certification in all other member countries of the CB Scheme. The Scheme is based on the use of international (IEC) Standards. If some members' national standards are not yet completely harmonized with IEC Standards, national differences are permitted if clearly declared to all other members. The CB Scheme utilizes CB Test Certificates to attest that product samples have successfully passed the appropriate tests and are in compliance with the requirements of the relevant IEC Standard and with the declared national differences of various member countries.


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Telephone: 714-898-6551 • Facsimile: 714-894-9248
e-mail: sales@cdipower.com

All information is subject to change without notice.

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