EQUIPMENT (I.T.E.), AGENCIES REQUIREMENTS, LABEL INFORMATION
AND MARKING REQUIREMENT.
Department of Health and Human Services (DHHS)
|COUNTRIES APPLICABLE TO||USA and any other countries who want to sell their products in USA|
|ORIGINATING COUNTRY( S)||USA|
|WHAT IS MEASURED OR PERTAINED TO||X-Radiation for CRT and Laser products of ITE Equipment. |
Coloberate with FDa (Food and Drug adminstration)
|VERSIONS STANDARDS||DHHS, Standards, Self, Declaration|
DHHS is the Department of Federal Government; this department deals with the Food and Drug administration who cares for the safety of the human body. In our case they would like to see the radiation emission coming out from the CRT Monitors, CD-Rom, DVD-Rom, Optical Drives and Laser Printers.
In order to get the DHHS approval we have to submit the test data to DHHS. The normal time frame to get the DHHS approval or accession Number is 40 days (after receiving the documents).
Some of the products such as CD-Rom, DVD-Rom and the Laser Printers are exempted from submittals every time, because the diode emission is less than Class I category. They need to submit only once a year in the form of annual Report. The annual Report should be submitted to DHHS before august 31st of every year.
Manufacturers of TV products incorporating cathode ray tubes must submit reports to FDa and must comply according to 21 CFR, subpart J. The compliance statement should read like" Complies with FDa Radiation Performance Standard 21 CFR Subchapter J." Please see the attachment .
Manufacturers of Laser products such as CD-Rom, Laser Printers etc. should comply according to 21 CFR, Chapter I, Subchapter J. The compliance statement should read: "Complies with 21 CFR, Chapter I, Subchapter J." (Please see below for DHHS compliance statement.) The wording in the owner’s manual is not required if you indicate in the manual that it is acceptable.
According to new rules and regulations the manufacturer need only maintain records enabling the tracing of a product via lot number or serial number to the first distribution point only.