Source: http://www.law.cornell.edu/cfr/text/21/1020.32
Timestamp: 2013-06-19 14:01:15
Document Index: 423104331

Matched Legal Cases: ['art 1020', '§ 1020', '§ 1020', '§ 1020', '§ 1020', '§ 1020', '§ 1020', '§ 1020', '§ 1020', '§ 1020', '§ 1020', '§ 1020', '§ 1020', '§ 1020', '§ 1020', '§ 1020', '§ 1020', '§ 1020', '§ 1020', '§ 1020', '§ 1020', '§ 1020', '§ 1020', '§ 321', '§ 351', '§ 352', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 371', '§ 381']

21 CFR 1020.32 - Fluoroscopic equipment. | Title 21 - Food and Drugs | Code of Federal Regulations | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter J › Part 1020 › Section 1020.32	prev | next
21 CFR 1020.32 - Fluoroscopic equipment.
(a) Primary protective barrier—
(2) Measuring compliance.
(b) Field limitation—
(1) Angulation.
(2) Further means for limitation.
(3) Non-image-intensified fluoroscopy.
(4) Fluoroscopy and radiography using the fluoroscopic imaging assembly with inherently circular image receptors.
(i) For fluoroscopic equipment manufactured before June 10, 2006, other than radiation therapy simulation systems, the following applies:
(5) Fluoroscopy and radiography using the fluoroscopic imaging assembly with inherently rectangular image receptors.
(6) Override capability.
(c) Activation of tube.
(d) Air kerma rates.
(1) Fluoroscopic equipment manufactured before May 19, 1995—
(i) Equipment provided with automatic exposure rate control (AERC) shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 88 mGy per minute (vice 10 R/min exposure rate) at the measurement point specified in § 1020.32(d)(3), except as specified in § 1020.32(d)(1)(v).
(ii) Equipment provided without AERC shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 44 mGy per minute (vice 5 R/min exposure rate) at the measurement point specified in § 1020.32(d)(3), except as specified in § 1020.32(d)(1)(v).
(iii) Equipment provided with both an AERC mode and a manual mode shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 88 mGy per minute (vice 10 R/min exposure rate) in either mode at the measurement point specified in § 1020.32(d)(3), except as specified in § 1020.32(d)(1)(v).
(iv) Equipment may be modified in accordance with § 1020.30(q) to comply with § 1020.32(d)(2). When the equipment is modified, it shall bear a label indicating the date of the modification and the statement:
(B) When a mode of operation has an optional high-level control, in which case that mode shall not be operable at any combination of tube potential and current that will result in an AKR in excess of the rates specified in § 1020.32(d)(1)(i), (d)(1)(ii), or (d)(1)(iii) at the measurement point specified in § 1020.32(d)(3), unless the high-level control is activated. Special means of activation of high-level controls shall be required. The high-level control shall be operable only when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high-level control is being employed.
(2) Fluoroscopic equipment manufactured on or after May 19, 1995—
(i) Shall be equipped with AERC if operable at any combination of tube potential and current that results in an AKR greater than 44 mGy per minute (vice 5 R/min exposure rate) at the measurement point specified in § 1020.32(d)(3). Provision for manual selection of technique factors may be provided.
(ii) Shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 88 mGy per minute (vice 10 R/min exposure rate) at the measurement point specified in § 1020.32(d)(3), except as specified in § 1020.32(d)(2)(iii) :
(C) When a mode of operation has an optional high-level control and the control is activated, in which case the equipment shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 176 mGy per minute (vice 20 R/min exposure rate) at the measurement point specified in § 1020.32(d)(3). Special means of activation of high-level controls shall be required. The high-level control shall be operable only when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high-level control is being employed.
(3) Measuring compliance.
(f) Indication of potential and current.
(g) Source-skin distance.
(1) Means shall be provided to limit the source-skin distance to not less than 38 cm on stationary fluoroscopes and to not less than 30 cm on mobile and portable fluoroscopes. In addition, for fluoroscopes intended for specific surgical application that would be prohibited at the source-skin distances specified in this paragraph, provisions may be made for operation at shorter source-skin distances but in no case less than 20 cm. When provided, the manufacturer must set forth precautions with respect to the optional means of spacing, in addition to other information as required in § 1020.30(h).
(2) For stationary, mobile, or portable C-arm fluoroscopic systems manufactured on or after June 10, 2006, having a maximum source-image receptor distance of less than 45 cm, means shall be provided to limit the source-skin distance to not less than 19 cm. Such systems shall be labeled for extremity use only. In addition, for those systems intended for specific surgical application that would be prohibited at the source-skin distances specified in this paragraph, provisions may be made for operation at shorter source-skin distances but in no case less than 10 cm. When provided, the manufacturer must set forth precautions with respect to the optional means of spacing, in addition to other information as required in § 1020.30(h).
(h) Fluoroscopic irradiation time, display, and signal.
(1) Fluoroscopic equipment manufactured before June 10, 2006, shall be provided with means to preset the cumulative irradiation time of the fluoroscopic tube. The maximum cumulative time of the timing device shall not exceed 5 minutes without resetting. A signal audible to the fluoroscopist shall indicate the completion of any preset cumulative irradiation-time. Such signal shall continue to sound while x-rays are produced until the timing device is reset. Fluoroscopic equipment may be modified in accordance with § 1020.30(q) to comply with the requirements of § 1020.32(h)(2). When the equipment is modified, it shall bear a label indicating the statement:
(i) A display of the fluoroscopic irradiation time at the fluoroscopist's working position. This display shall function independently of the audible signal described in § 1020.32(h)(2)(ii). The following requirements apply:
(i) Mobile and portable fluoroscopes.
(j) Display of last-image-hold (LIH).
(4) The predetermined or selectable options for producing the LIH radiograph shall be described in the information required by § 1020.30(h). The information shall include a description of any technique factors applicable for the selected option and the impact of the selectable options on image characteristics and the magnitude of radiation emissions.
(k) Displays of values of AKR and cumulative air kerma.
(4) The AKR and cumulative air kerma shall represent the value for conditions of free-in-air irradiation at one of the following reference locations specified according to the type of fluoroscope. The reference location shall be identified and described specifically in the information provided to users according to § 1020.30(h)(6)(iii).
(i) For fluoroscopes with x-ray source below the x-ray table, x-ray source above the table, or of lateral type, the reference locations shall be the respective locations specified in § 1020.32(d)(3)(i), (d)(3)(ii), or (d)(3)(v) for measuring compliance with air-kerma rate limits.
Title 21 published on 2012-04-01no entries appear in the Federal Register after this date. This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.United States CodeUSC : Title 21 - FOOD AND DRUGS§ 321 - Definitions; generally§ 351 - Adulterated drugs and devices§ 352 - Misbranded drugs and devices§ 360e - Premarket approval21 USC § 360e–1 - Pediatric uses of devices§ 360f - Banned devices§ 360g - Judicial review§ 360h - Notification and other remedies§ 360i - Records and reports on devices§ 360j - General provisions respecting control of devices intended for human use§ 360hh - Definitions§ 360ii - Program of control§ 360jj - Studies by Secretary§ 360kk - Performance standards for electronic products21 USC § - § 360mm - Imports§ 360nn - Inspection, records, and reports21 USC § - § 360pp - Enforcement§ 360qq - Repealed. § 360rr - Federal-State cooperation§ 360ss - State standards§ 371 - Regulations and hearings§ 381 - Imports and exports