Title 21

Volume 8 CHAPTER I SUBCHAP J

Subchapter J - Radiological Health

21:8.0.1.3.37PART 1000
PART 1000 - GENERAL
21:8.0.1.3.37.1SUBPART A
Subpart A - General Provisions
21:8.0.1.3.37.1.1.1SECTION 1000.1
     1000.1 General.
21:8.0.1.3.37.1.1.2SECTION 1000.3
     1000.3 Definitions.
21:8.0.1.3.37.2SUBPART B
Subpart B - Statements of Policy and Interpretation
21:8.0.1.3.37.2.1.1SECTION 1000.15
     1000.15 Examples of electronic products subject to the Radiation Control for Health and Safety Act of 1968.
21:8.0.1.3.37.3SUBPART C
Subpart C - Radiation Protection Recommendations
21:8.0.1.3.37.3.1.1SECTION 1000.50
     1000.50 Recommendation for the use of specific area gonad shielding on patients during medical diagnostic x-ray procedures.
21:8.0.1.3.37.3.1.2SECTION 1000.55
     1000.55 Recommendation for quality assurance programs in diagnostic radiology facilities.
21:8.0.1.3.37.3.1.3SECTION 1000.60
     1000.60 Recommendation on administratively required dental x-ray examinations.
21:8.0.1.3.38PART 1002
PART 1002 - RECORDS AND REPORTS
21:8.0.1.3.38.1SUBPART A
Subpart A - General Provisions
21:8.0.1.3.38.1.1.1SECTION 1002.1
     1002.1 Applicability.
21:8.0.1.3.38.1.1.2SECTION 1002.2
     1002.2 [Reserved]
21:8.0.1.3.38.1.1.3SECTION 1002.3
     1002.3 Notification to user of performance and technical data.
21:8.0.1.3.38.1.1.4SECTION 1002.4
     1002.4 Confidentiality of information.
21:8.0.1.3.38.1.1.5SECTION 1002.7
     1002.7 Submission of data and reports.
21:8.0.1.3.38.2SUBPART B
Subpart B - Required Manufacturers' Reports for Listed Electronic Products
21:8.0.1.3.38.2.1.1SECTION 1002.10
     1002.10 Product reports.
21:8.0.1.3.38.2.1.2SECTION 1002.11
     1002.11 Supplemental reports.
21:8.0.1.3.38.2.1.3SECTION 1002.12
     1002.12 Abbreviated reports.
21:8.0.1.3.38.2.1.4SECTION 1002.13
     1002.13 Annual reports.
21:8.0.1.3.38.3SUBPART C
Subpart C - Manufacturers' Reports on Accidental Radiation Occurrences
21:8.0.1.3.38.3.1.1SECTION 1002.20
     1002.20 Reporting of accidental radiation occurrences.
21:8.0.1.3.38.4SUBPART D
Subpart D - Manufacturers' Records
21:8.0.1.3.38.4.1.1SECTION 1002.30
     1002.30 Records to be maintained by manufacturers.
21:8.0.1.3.38.4.1.2SECTION 1002.31
     1002.31 Preservation and inspection of records.
21:8.0.1.3.38.5SUBPART E
Subpart E - Dealer and Distributor Records
21:8.0.1.3.38.5.1.1SECTION 1002.40
     1002.40 Records to be obtained by dealers and distributors.
21:8.0.1.3.38.5.1.2SECTION 1002.41
     1002.41 Disposition of records obtained by dealers and distributors.
21:8.0.1.3.38.5.1.3SECTION 1002.42
     1002.42 Confidentiality of records furnished by dealers and distributors.
21:8.0.1.3.38.6SUBPART F
Subpart F - Exemptions From Records and Reports Requirements
21:8.0.1.3.38.6.1.1SECTION 1002.50
     1002.50 Special exemptions.
21:8.0.1.3.38.6.1.2SECTION 1002.51
     1002.51 Exemptions for manufacturers of products intended for the U.S. Government.
21:8.0.1.3.39PART 1003
PART 1003 - NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY
21:8.0.1.3.39.1SUBPART A
Subpart A - General Provisions
21:8.0.1.3.39.1.1.1SECTION 1003.1
     1003.1 Applicability.
21:8.0.1.3.39.1.1.2SECTION 1003.2
     1003.2 Defect in an electronic product.
21:8.0.1.3.39.1.1.3SECTION 1003.5
     1003.5 Effect of regulations on other laws.
21:8.0.1.3.39.2SUBPART B
Subpart B - Discovery of Defect or Failure To Comply
21:8.0.1.3.39.2.1.1SECTION 1003.10
     1003.10 Discovery of defect or failure of compliance by manufacturer; notice requirements.
21:8.0.1.3.39.2.1.2SECTION 1003.11
     1003.11 Determination by Secretary that product fails to comply or has a defect.
21:8.0.1.3.39.3SUBPART C
Subpart C - Notification
21:8.0.1.3.39.3.1.1SECTION 1003.20
     1003.20 Notification by the manufacturer to the Secretary.
21:8.0.1.3.39.3.1.2SECTION 1003.21
     1003.21 Notification by the manufacturer to affected persons.
21:8.0.1.3.39.3.1.3SECTION 1003.22
     1003.22 Copies of communications sent to purchasers, dealers or distributors.
21:8.0.1.3.39.4SUBPART D
Subpart D - Exemptions From Notification Requirements
21:8.0.1.3.39.4.1.1SECTION 1003.30
     1003.30 Application for exemption from notification requirements.
21:8.0.1.3.39.4.1.2SECTION 1003.31
     1003.31 Granting the exemption.
21:8.0.1.3.40PART 1004
PART 1004 - REPURCHASE, REPAIRS, OR REPLACEMENT OF ELECTRONIC PRODUCTS
21:8.0.1.3.40.0.1.1SECTION 1004.1
     1004.1 Manufacturer's obligation to repair, replace, or refund cost of electronic products.
21:8.0.1.3.40.0.1.2SECTION 1004.2
     1004.2 Plans for the repair of electronic products.
21:8.0.1.3.40.0.1.3SECTION 1004.3
     1004.3 Plans for the replacement of electronic products.
21:8.0.1.3.40.0.1.4SECTION 1004.4
     1004.4 Plans for refunding the cost of electronic products.
21:8.0.1.3.40.0.1.5SECTION 1004.6
     1004.6 Approval of plans.
21:8.0.1.3.41PART 1005
PART 1005 - IMPORTATION OF ELECTRONIC PRODUCTS
21:8.0.1.3.41.1SUBPART A
Subpart A - General Provisions
21:8.0.1.3.41.1.1.1SECTION 1005.1
     1005.1 Applicability.
21:8.0.1.3.41.1.1.2SECTION 1005.2
     1005.2 Definitions.
21:8.0.1.3.41.1.1.3SECTION 1005.3
     1005.3 Importation of noncomplying goods prohibited.
21:8.0.1.3.41.2SUBPART B
Subpart B - Inspection and Testing
21:8.0.1.3.41.2.1.1SECTION 1005.10
     1005.10 Notice of sampling.
21:8.0.1.3.41.2.1.2SECTION 1005.11
     1005.11 Payment for samples.
21:8.0.1.3.41.3SUBPART C
Subpart C - Bonding and Compliance Procedures
21:8.0.1.3.41.3.1.1SECTION 1005.20
     1005.20 Hearing.
21:8.0.1.3.41.3.1.2SECTION 1005.21
     1005.21 Application for permission to bring product into compliance.
21:8.0.1.3.41.3.1.3SECTION 1005.22
     1005.22 Granting permission to bring product into compliance.
21:8.0.1.3.41.3.1.4SECTION 1005.23
     1005.23 Bonds.
21:8.0.1.3.41.3.1.5SECTION 1005.24
     1005.24 Costs of bringing product into compliance.
21:8.0.1.3.41.3.1.6SECTION 1005.25
     1005.25 Service of process on manufacturers.
21:8.0.1.3.42PART 1010
PART 1010 - PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL
21:8.0.1.3.42.1SUBPART A
Subpart A - General Provisions
21:8.0.1.3.42.1.1.1SECTION 1010.1
     1010.1 Scope.
21:8.0.1.3.42.1.1.2SECTION 1010.2
     1010.2 Certification.
21:8.0.1.3.42.1.1.3SECTION 1010.3
     1010.3 Identification.
21:8.0.1.3.42.1.1.4SECTION 1010.4
     1010.4 Variances.
21:8.0.1.3.42.1.1.5SECTION 1010.5
     1010.5 Exemptions for products intended for United States Government use.
21:8.0.1.3.42.2SUBPART B
Subpart B - Alternate Test Procedures
21:8.0.1.3.42.2.1.1SECTION 1010.13
     1010.13 Special test procedures.
21:8.0.1.3.42.3SUBPART C
Subpart C - Exportation of Electronic Products
21:8.0.1.3.42.3.1.1SECTION 1010.20
     1010.20 Electronic products intended for export.
21:8.0.1.3.43PART 1020
PART 1020 - PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS
21:8.0.1.3.43.0.1.1SECTION 1020.10
     1020.10 Television receivers.
21:8.0.1.3.43.0.1.2SECTION 1020.20
     1020.20 Cold-cathode gas discharge tubes.
21:8.0.1.3.43.0.1.3SECTION 1020.30
     1020.30 Diagnostic x-ray systems and their major components.
21:8.0.1.3.43.0.1.4SECTION 1020.31
     1020.31 Radiographic equipment.
21:8.0.1.3.43.0.1.5SECTION 1020.32
     1020.32 Fluoroscopic equipment.
21:8.0.1.3.43.0.1.6SECTION 1020.33
     1020.33 Computed tomography (CT) equipment.
21:8.0.1.3.43.0.1.7SECTION 1020.40
     1020.40 Cabinet x-ray systems.
21:8.0.1.3.44PART 1030
PART 1030 - PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO FREQUENCY EMITTING PRODUCTS
21:8.0.1.3.44.0.1.1SECTION 1030.10
     1030.10 Microwave ovens.
21:8.0.1.3.45PART 1040
PART 1040 - PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS
21:8.0.1.3.45.0.1.1SECTION 1040.10
     1040.10 Laser products.
21:8.0.1.3.45.0.1.2SECTION 1040.11
     1040.11 Specific purpose laser products.
21:8.0.1.3.45.0.1.3SECTION 1040.20
     1040.20 Sunlamp products and ultraviolet lamps intended for use in sunlamp products.
21:8.0.1.3.45.0.1.4SECTION 1040.30
     1040.30 High-intensity mercury vapor discharge lamps.
21:8.0.1.3.46PART 1050
PART 1050 - PERFORMANCE STANDARDS FOR SONIC, INFRASONIC, AND ULTRASONIC RADIATION-EMITTING PRODUCTS
21:8.0.1.3.46.0.1.1SECTION 1050.10
     1050.10 Ultrasonic therapy products.