PTP’s Health Physics Courses - the best in hands-on radiation safety training

 

    > by Agency   > FDA   > Complianceshow list of document types

Compliance Testing Procedures Companion Documents

Resource Manual for Compliance Test Parameters of Diagnostic X-ray Systems (July 1999)

Compliance Program for Field Compliance Testing of Cabinet X-ray Equipment (CP 7386.004); Final Guidance for Industry and FDA Staff (February 2001)

Routine Compliance Testing Procedures for Diagnostic X-ray Systems

Introduction

Part I

General Information (Form FDA 3071)

Edit Checks

Field Test Record

Part II

Above X-Ray Source Radiographic Systems (Form FDA 2784)

Edit Checks

Calculation Techniques

Field Test Record

Supplement 1 - Wall Cassette

Edit Checks Supplement 1

Calculation Techniques Supplement 1

Chiropractic Systems Supplement 2

Edit Checks Supplement 2

Part III

Undertable X-ray Source Fluoroscopic and Spot Film Systems (Form FDA 2786)

Edit Checks

Calculation Techniques

Field Test Record

Part IV

Mobile Radiographic Systems (Form FDA 2783)

Edit Checks

Calculation Techniques

Field Test Record

Part V

Dental Radiographic Systems (Form FDA 2785)

Edit Checks

Calculation Techniques

Field Test Record

Part VI

Above X-ray Source Fluoroscopic and Spot Film Systems (Form FDA 3069)

Edit Checks

Calculation Techniques

Field Test Record

Part VII

Peak Kilovoltage Determination - Radiographic Systems (KVA) (Form FDA 3068)

Edit Checks

Calculation Techniques

Field Test Record

Peak Kilovoltage Determination - Radiographic Systems (KVB)

Parts VIII and IX (also Parts VI, and VII are repeated)

Part VI Above Table Source Fluoroscopic and Spot Film Systems Form FDA 3069; Part VII, Peak Kilovoltage Determination Radiographic Systems Form 3068 (page 21); Part VIII, Mammographic Systems Form FDA 3070 (page 33); Part IX, Vertically Mounted Cassette Holder Form 3261(page 53);

Parts X and XI

Part X: C-Arm Fluoroscopic and Spot-Film Systems Form FD 3260; (page 72) Part XI Head and Neck Radiographic Systems Form 3296

Appendices A, B, C and Equipment Descriptions

Appendix A, Guidance for Completing the Field Test Record; Appendix B , Tripod Setup (page 6); Appendix C Estimation of Anode Heating (page 8); Equipment Descriptions: Part I , Equipment List (page 12); Part II , Test Stand Drawings (page 14); Part III, Instruction Manual for the 1015F X-ray Monitor (page 39); Part IV, Light Localizer Measurements (page 52); Part V, Exposure and Development Procedures for Linagraphic Paper (page 56); Part VI, Operators Manual For GM Ratemeters (page 58);