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FDA detection standard of radiation type electronic products

Source: ShenZhenTobyTechnologyCo.,LtdPopularity: 654Time: 2016-04-18SMB

FDA detection standard of radiation type electronic products

Performance standards overview
21CFR1020.10 television receiver
Receiver and display for receiving a signal and converting a signal into a television image signal.
The radiation limit is: to make the receiver user adjustment knob and maintenance device in the maximum state and in one of the most effective results of the worst fault condition, the distance from the surface of the tube to the surface of the 5cm ray can not exceed 0.5mR/hr.

21CFR1020.20 cold cathode ray tube
The ray at 30cm cannot exceed 0.5mR/hr.
Requires a user warning label.

X 21CFR1020.30 ray diagnostic apparatus and its main components
Radiation source 1 meters away from the radiation within an hour can not exceed 100mR, for other parts, 5cm radiation leakage within one hour can not exceed 2mR.
X 21CFR1020.31 radiographic equipment
21CFR1020.32 fluorescence inspection equipment
X ray (CT) equipment for 21CFR1020.33 numerical control fault analysis
21CFR1020.40 bin X ray detection system
21CFR1030.10 microwave oven
21CFR1040.10 laser products and laser system
21CFR1040.11 special laser products
21CFR1040.20 lamp and lamp products
21CFR1040.30 high strength mercury vapor discharge lamp
21CFR1050.10 ultrasonic treatment equipment

Product reporting requirements overview
21CFR1010.41010.5 involves product change and exception handling
21CFR1002.20 accidental radiation
21CFR1002.10,11,12 Product Report
21CFR1002.13 product Annual Report
21CFR1002.20 does not conform to the notice
Overview of radiation management regulations

Defect of 21CFR1003.2 electronic products
21CFR1003.10/11 does not meet or defect definition
21CFR1003.30/31 from the notice of the situation
21CFR1004.1/2/3 re purchase, repair and replacement
21CFR1005.3/10 import requirements
21CFR1005.21/22/23/24/25 to improve the product has been imported to qualified
21CFR1010.2/3 certificate and identification mark

Measures to be taken in violation of the regulations on the administration of radiation
FDA A. will take the management measures
Requirements for product recall (corrective action to be approved and confirmed);
Not to approve the quality control and test plan (i.e., to prohibit the import of the product);
(along with the United States Customs) the implementation of import alert, automatic detention or stop imports;
B. measures taken by local courts in the United States
Issued a ban on interstate commerce in the transport of the goods or requirements to provide reports and certificates;
For violation of the provisions of the report, in violation of the provisions of the certification and does not meet the standard requirements to be punished (fine).