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RULE §229.407Sterilization

(a) A studio or temporary location is required to utilize instruments that have been prepared as described in §229.409(a)-(e) of this title (relating to Tattooing and Body Piercing Instruments and Jewelry). The studio or temporary location shall use sterilization equipment that is approved by the United States Food and Drug Administration for the purpose of sterilization, and adequate in size to accommodate necessary utensils and instruments. A copy of the manufacturer's recommended procedures for operation of the sterilization unit(s) must be available for inspection by an authorized agent at the time of inspection.

(b) Each person responsible for the sterilization of instruments and jewelry shall be able to demonstrate to the department's authorized agent the correct sterilization procedures and the proper operation of autoclave and/or dry heat sterilization equipment.

(c) After each use, the reusable instruments and jewelry shall be cleansed to remove blood and tissue residue before sterilization as described in §229.409(n) of this title.

(d) Instruments and jewelry requiring sterilization shall be packed in packages approved for the sterilization unit. Instruments and jewelry shall be packed individually, or as a set provided such set is intended to be used for a single procedure. Each package shall be labeled with the date of sterilization and the initials of the person sterilizing the instruments. Packaged sterilized instruments shall be kept in a sterile condition and stored in a clean dust-tight container when not in use. Instruments and jewelry may be sterilized immediately before tattooing or body piercing without the use of sterilization packages as provided by the sterilization unit's manual. The studio must keep records in accordance with subsection (g) of this section.

(e) Each package of instruments and jewelry sterilized shall be monitored for sterilization by the use of chemical/heat sensitive indicators.

(f) Each sterilization unit used by the studio to sterilize instruments and jewelry must have a spore test performed each calendar month by an approved laboratory, and the test results be made available for inspection.

(g) Each studio or temporary location shall maintain sterilization records. The information shall be permanently recorded and made available for examination by an authorized agent in the studio for at least two years from the date of the last entry. These permanent records shall be maintained at the studio and shall include the following:

  (1) date of sterilization;

  (2) quantity and type of instruments to be sterilized; and

  (3) name or initials of the individual sterilizing the instruments.

(h) Sterilized instruments and jewelry stored in accordance with the sterilization unit owner's manual and stored in accordance with the sterilization packet manufacturer's labeling or letter provided by the manufacturer of the sterilization packets will be considered sterile for the length of time set out in the sterilization unit owner's manual or packet labeling or supporting documentation. If the studio personnel cannot provide a manual for the sterilization equipment at the time of inspection or if no length of time is set out by the sterilization unit's manual, the equipment must be stored in an approved manner and the instruments and jewelry not used within 60 days after sterilization shall no longer be considered sterile. If presterilized instruments are used, the artist shall obtain documentation from the manufacturer that describes the method of sterilization utilized by the manufacturer and the manufacturer's recommendations for storage and maintenance of sterility. This documentation shall be available for inspection by an authorized agent. The artist shall follow the manufacturer's instructions for storage and maintenance of sterility.

(i) One of the following methods of sterilization shall be used.

  (1) Autoclave--steam under pressure:

    (A) 121 degrees Celsius (250 degrees Fahrenheit) and a pressure of at least 15 pounds per square inch for not less than 30 minutes after the chamber of the autoclave has reached the required temperature and pressure; or

    (B) as specified in the manufacturer's operator's manual.

  (2) Dry heat sterilization:

    (A) 160 degrees Celsius (320 degrees Fahrenheit) for not less than one hour under atmospheric pressure after the sterilizer has reached the required temperature; or

    (B) as specified in the manufacturer's operator's manual.

Source Note: The provisions of this §229.407 adopted to be effective April 23, 2000, 25 TexReg 3272; amended to be effective January 1, 2005, 29 TexReg 11982

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