DIAGNOSTIC INSTALLATIONS GENERAL REQUIREMENTS


§ 221.21. Diagnostic equipment requirements.

 (a)  Diagnostic systems incorporating one or more certified components shall comply with 21 CFR 1020.30—1020.33.

 (b)  Equipment registered after January 24, 2019, must comply with 21 CFR 1010.2 (relating to certification).

Authority

   The provisions of this §  221.21 amended under sections 301 and 302 of the Radiation Protection Act (35 P.S. § §  7110.301 and 7110.302); and section 1920-A of The Administrative Code of 1929 (71 P.S. §  510-20).

Source

   The provisions of this §  221.21 adopted February 1, 1972, effective February 2, 1972, 2 Pa.B. 212; amended December 18, 1987, effective December 19, 1987, 17 Pa.B. 5235; amended October 2, 1998, effective October 3, 1998, 28 Pa.B. 4894; amended October 26, 2018, effective January 24, 2019, 48 Pa.B. 6791. Immediately preceding text appears at serial page (304493).

Cross References

   This section cited in 25 Pa. Code §  221.35a (relating to fluoroscopic X-ray systems).



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