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  5. Inspection and Field Testing of Radiation-Emitting Electronic Products: Attachment E: Specific Instructions for Television Product Inspections
  1. Guidance Documents (Medical Devices and Radiation-Emitting Products)

Inspection and Field Testing of Radiation-Emitting Electronic Products: Attachment E: Specific Instructions for Television Product Inspections

Background

The Television Product Performance Standard (the standard) was designed to protect the public from x-radiation hazards associated with early cathode-ray-tube (CRT) television sets. The radiation emitted from these products has been dramatically reduced over the years as a result of the standard, and by improvements in technology and design. The hazards of x-ray emissions from CRT televisions and video monitors are further diminished because of a well-established and conscientious industry and the increasing market for flat panel LCD and plasma displays that do not pose a radiation hazard. A minimal, but risk-based and continued presence by FDA is needed in the television industry to ensure continued compliance with radiation safety standards so long as there is a market for CRT products. This presence is limited to for-cause manufacturer inspection and laboratory inspection. No field tests are conducted on television products.

Specific Instructions

Television product manufacturers should be inspected or tested at CDRH direction. Television product manufacturers are all located overseas, and all inspections will require foreign travel. Reasons for manufacturer inspection include:

  • Manufacturers with known or suspected problems based on previous inspection or complaints
  • New manufacturers not yet inspected
  • Manufacturers introducing new CRT-based technology to the US market
  • Manufacturers with a large potion of the US market share.

WEAC laboratory analysts have knowledge of general EPRC requirements and also have specialized training in the television product performance standard. These analysts have experience planning and conducting foreign television manufacturer inspections. WEAC analysts should perform these inspections and field tests and may train additional field staff.

CDRH is responsible for review of television manufacturer inspection observations and initiating administrative or regulatory follow-up.

References

Performance Standard-Television Products
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=1020.10

Refer to the television products main page for guidance documents and additional information.

Television Product Codes

Translation of 2-Digit Code Product Name Product Code CFR Definition
TV Receivers & Products Containing Same Oscilloscope (Exempted), TV Receivers & Products, Non-Medical 94 RAY 1020.10 A device that depicts on a screen periodic changes in an electric quantity, as voltage or current, using a cathode ray tube and is not used in a medical application
TV Receivers & Products Containing Same Television Receiver, Medical Imaging, Color 94 RAZ 1020.10 A television receiver using a color cathode ray tube to display medical images in colors.
TV Receivers & Products Containing Same Television Receiver, Medical Imaging, Monochrome 94 RBA 1020.10 A television receiver using a monochrome cathode ray tube to display medical images in black and white with shades of gray or in different shades of one color.
TV Receivers & Products Containing Same Television Receiver, General Purpose, Color, Non-Medical 94 RBB 1020.10 An electronic product with no medical claims designed to receive and, using a color cathode ray tube, to display a television picture in colors from broadcast, cable, video disk player, video recorder, computer or closed circuit television signals.
TV Receivers & Products Containing Same Television Receiver, General Purpose, Monochrome, Non-Medical 94 RBC 1020.10 An electronic product with no medical claims designed to receive and, using a monochrome cathode ray tube, to display a television picture in black and white with shades of gray or in different shades of one color from broadcast, cable, video disk player, video recorder, computer or closed circuit television signals.
TV Receivers & Products Containing Same Video Monitor, Medical Imaging, Color 94 RBD 1020.10 An electronic product using a color cathode ray tube to display medical images in colors from signals from a computer or electronic medical device.
TV Receivers & Products Containing Same Video Monitor, General Purpose, Color 94 RBE 1020.10 An electronic product using a color cathode ray tube to display general images in colors from signals from a computer or electronic medical device.
TV Receivers & Products Containing Same Video Monitor, Medical Imaging, Monochrome 94 RBF 1020.10 An electronic product using a monochrome cathode ray tube to display medical images in black and white with shades of gray or in different shades of one color from signals from a computer or electronic medical device.
TV Receivers & Products Containing Same Video Monitor, General Purpose, Monochrome 94 RBG 1020.10 An electronic product using a monochrome cathode ray tube to display general images in black and white with shades of gray or in different shades of one color from signals from a computer or electronic medical device.
TV Receivers & Products Containing Same Projector, TV Receivers & Products 94 RBH 1020.10 Electronic products that use a cathode ray tube or several cathode ray tubes to generate television images which are projected on a screen either from the front or from the rear.
TV Receivers & Products Containing Same TV View Finder, TV Receivers and Products 94 RBI 1020.10 An electronic product using a cathode ray tube to display the image seen through the lens of a camcorder. To be exempt the cathode ray tube must operate under 5 kilovolts under the test conditions in the standard (Phase III).
TV Receivers & Products Containing Same Camera, Television, Surgical, Without Audio 79 FWB 1020.10  
TV Receivers & Products Containing Same Camera, Television, Surgical, With Audio 79 FWC 1020.10  
TV Receivers & Products Containing Same Camera, Television, Microsurgical, Without Audio 79 FWD 1020.10  
TV Receivers & Products Containing Same Camera, Television, Microsurgical, With Audio 79 FWE 1020.10  
TV Receivers & Products Containing Same Camera, Television, Endoscopic, Without Audio 79 FWF 1020.10  
TV Receivers & Products Containing Same Camera, Televsion, Endoscopic, With Audio 79 FWG 1020.10  
TV Receivers & Products Containing Same System, Reading, Television, Closed-Circuit 79 HJG 1020.10  
Other 94 RZZ Unknown Other electronic products using cathode ray tubes to display television images from broadcast, cable, video disk player, video recorder, computer or closed circuit television signals.

Classification of Non-compliant Items

Emission Limit
1020.10(c) Exceeds exposure rate limit    
1020.10(c)(1) Radiation emission > 10mR in one hour Major Class A
1020.10(c)(3) Test conditions are not in accordance with requirements Minor Class B
1020.10(c)(4) Critical component warning label missing or inadequate Minor Class B

Sample Television Product Inspection Checklist

Manufacturer Identification

Manufacturer Name :  
Plant Location:  
Date(s) of Visit:  

FDA Personnel

Name Title Organization
     
     
     
     
     
LIST OF EXHIBITS
     Organization Chart      Sampling Procedures      Engineering Test Plan      Service Manual(s)
  Incoming Q. C. Test Procedures   Reaction Plan Procedures   Engineering Test Records  

Mfr's Agent agreement

(21 CFR 1005.25)

 

Instrument Calibration

Control Log

 

Labels

(ID, Cert. and Crit. Comp.)

  Vendor Test Data   Other:
  X-Radiation Test Record   Production Line Procedures   Manufacturer Distribution Records    
GENERAL EVALUATION OF THE SPECIFIC AREAS INSPECTED
Specific Area Inspected Gen. Eval.* See Attach. Details on Page Specific Area Inspected Gen. Eval.* See Attach. Details on Page
General Organization

 

 

 

 

 

 

 

Production Line Q.C. Procedures

     
Engineering Test Plan

 

 

 

 

 

 

 

Reaction Plan

     
Incoming Materials Testing Program

 

 

 

 

 

 

 

X-Radiation Test Records

     
Written Comm. Concerning Radiation Safety

 

 

 

 

 

 

 

Sampling Procedures for Production Rad. Testing

     
Manufacturer Distribution Records

 

 

 

 

 

 

 

Radiation Testing Prog. for Production Receivers

     
Instrument Calibration

 

 

 

 

 

 

 

 

     

*Legend for Evaluation: A - Satisfactory B - Questionable C - Unsatisfactory

NARRATIVE DESCRIPTION OF FINDINGS

1. PRODUCTION SUMMARY

MAXIMUM NUMBER OF PRODUCTION LINES =

Line Name Model No. Brand Rate (Sets/day) Meets Abbr. Rep. Criteria? Line Name Model No. Brand Rate (Sets/day) Meets Abbr. Rep. Criteria?
                   
                   
2. GENERAL ORGANIZATION
1. Flowchart of company functions and organization available?      
    Yes   No SeeExhibit:        
2. Corresponding official is :        
    Q.A.   Q.C.   Product Safety   Engineering
    Production   Sales   Other:        
3. Is the Compliance Testing Program separate from Production?   Yes   No
4. (Foreign companies only) Does the company have a Manufacture's Agent who lives in the U.S.? (21 CFR 1005.25)
    Yes     No          
3. ENGINEERING
1. Test Plan
a) The receiver selected for the Engineering Analysis is a:
    Prototype   Preproduction   Other:  
b) The engineering x-radiation testing is performed by:
    Q.C.   Engineering   Other:  
c) The acceptance/rejection criteria for new design is:    
d) The A/R decision is made by:  
e) Life test prior to mass production?   Yes   No
         
2. Engineering Test Records
a) Are records kept?
    Yes, where?  
    No (Explain)  
b) Type of information kept on record:  
c) Is the worst tolerance chassis retained for further testing?   Yes   No  
4. INCOMING TESTS FOR CRITICAL COMPONENTS

1. Test Summary

Components Test Performed Sampling Plan Rejection Criteria Test Method
Yes No
CRTs          
Capacitors          
H.V. Transformers          
Yoke          
Others          
           
  Yes No
2. Incoming test records on file?    
3. CRTS tested In-House?    
If yes, Registered at TEPAC?    
a) Explain the CRT test procedure:        
b) X-Radiation Instrumentation used: Model Cal. Date    
         
         
4. If CRTs are tested by vendor does the vendor provide:    
a) test data for each lot?    
b) general guarantee of Engineering X-Radiation specifications    
5. INCOMING CHECK OF REQUIRED LABELS    
1. Are the labels, which are received at the incoming area, checked for compliance with 21 CFR 1010?    
2. If yes, are the labels compared with approved labels on file?    
6. COMMUNICATIONS CONCERNING RADIATION SAFETY    
1. Are records kept?    
2. Who responds to these questions?    
7. MANUFACTURER DISTRIBUTION RECORDS    
1. Are records kept? If Yes, where are they kept?:    
2. Information kept on record:    
Dealer/Distributor name and address?    
Date distributed?    
Model and serial No.?    
3. Are records computerized?    
4. Are dealers/distributors notified of their obligation to obtain and maintain purchaser records? (for non-exempt products)    
5. Are dealers/distributors notified of the exempt products?    
     
8. INSTRUMENT CALIBRATION    
1. Is the qualitative meter given a periodic (30 day) check for proper operation?    
2. Are the actual readings for each tube recorded?    
3. The date of the CST-l source used for the thirty-day check is:
4. Is it adjusted?    
5. Is the quantitativeinstrument checked to a source traceable to a NBS standard?    
6. Is there a system for reminding personnel that an instrument is due to be calibrated?    
7. Are there alternative x-radiation instruments available should the instruments in use require repair or calibration?    
9. SAMPLING PROCEDURES FOR PRODUCTION RADIATION TESTING Yes No
1. The samples for production testing are selected by:  
2. From: Each production line?    
Each shift?    
Each model?    
End of production line?    
Warehouse?    
3. Sample size:    
4. Lot size:    
5. How determined?    
6. Normal amount of production:    
7. Rejection criteria:  
Unit:   mR/hr Lot :   mR/hr  
10. REACTION PLAN UPON REJECTION (review actual rejection cases)    
1. Who is notified by the test technician?        
2. Who examines the cause?        
3. Disposition of the rejected lot while examining cause:        
4. Who issues the order to stop shipment and/or production?        
5. Are other lots (previous and/or subsequent) subjected to increased testing?    
6. Have there been any failures?    
If yes,was it documented ?    
7. Does the Reaction plan appear to be adequate?    

11. X-RADIATION TEST RECORDS

1. Where are records kept?            
2. Are they maintained for five years?   Yes   No  
3. How are they filed? (model, date, etc.)    

4. What information is recorded?

  Model/Chassis   Test Date   Technician   Beam Current   All Sides
  Serial #   Fault   High Voltage   X-Radiation   Background
 

5. Are any records in excess of the rejection limit?

  Yes, disposition of rejected units/lots:  
  No  
     

 

12. PRODUCTION LINE PROCEDURES Yes No
1. Shielding    
a) Is special shielding checked for proper placement?    
2. Sealed Controls    
a) Are they checked?    
b) Checking Method:   Visual   Mechanical
c) Do seals appear to be permanent?    
3. Labels    
a) Is the presence of labels being checked on line?    
b) Are labels readily viewable?    
c) Are they permanently affixed?    
13. PRODUCTION LINE PROCEDURES AND OPERATIONAL SAFETY TESTS
1) Chassis Number      
Yes No Yes No Yes No
2) B+ measured?            
% Checked % % %
Meter Calibration Current?            
Instructions Available?            
3) H.V. measured?            
% Checked % % %
Meter Calibration Current?            
Instructions Available?            
4) Hold Down/Safety Circuit Subassembly        
Finished product        
Instructions available?            

 

Comments:

14. RADIATION TESTING PROGRAM FOR PRODUCTION SETS

1. Test Instrumentation

Instruments Manufacturer Model Calibrated Operational Checks
Last Due Yes No
Qualitative Johnson TVX-1        
Quantitative Victoreen 440 RF/C        
Voltmeter            
Ammeter            
H.V. Meter            
2. Demonstration Test Number 1

a) Identification of receiver tested:

Chassis No.       Color   Black and White
CRT No.   Model No.  
Serial No.      
Sample selected by:  
Sample selected from:  

b) Labeling Information:

Label Viewable Obscured Missing Adhesion
Certification        
Date of manufacturer.        
Place of Manufacturer.        
Critical Component Warning        

c) Test Conditions:

Input voltage:    
User controls adjusted?     Yes   No        
Service controls adjusted?   Yes   No        
List adjusted controls:    
Describe worst-case failure:  
           
Usable Picture?   Yes   No  
Test pattern:  

d) Test Results:

Max. Qualitative:   counts/min at   kV and   ï�µA
Location:   Background:   counts/min
Max. Quantitative:   mR/hr at   kV and   ï�µA
Location:   Scan Rate:     inches/sec
Comments:

3. Demonstration Test Number 2

 

a) Identification of receiver tested:

Chassis No.       Color   Black and White
CRT No.   Model No.  
Serial No.      
Sample selected by:  
Sample selected from:  

b) Labeling Information:

Label Viewable Obscured Missing Adhesion
Certification        
Date of manufacturer.        
Place of Manufacturer.        
Critical Component Warning        

c) Test Conditions:

Input voltage:    
User controls adjusted?     Yes   No        
Service controls adjusted?   Yes   No        
List adjusted controls:    
Describe worst-case failure:  
           
Usable Picture?   Yes   No  
Test pattern:  

d) Test Results:

Max. Qualitative:   counts/min at   kV and   mA
Location:   Background:   counts/min
Max. Quantitative:   mR/hr at   kV and   mA
Location:   Scan Rate:     inches/sec
  Comments: