21 C.F.R. § 606.60

Current through September 30, 2024

Section 606.60 - Equipment

(a) Equipment used in the collection, processing, compatibility testing, storage and distribution of blood and blood components shall be maintained in a clean and orderly manner and located so as to facilitate cleaning and maintenance. The equipment shall be observed, standardized and calibrated on a regularly scheduled basis as prescribed in the Standard Operating Procedures Manual and shall perform in the manner for which it was designed so as to assure compliance with the official requirements prescribed in this chapter for blood and blood products.

(b) Equipment that shall be observed, standardized and calibrated with at least the following frequency, include but are not limited to:

Equipment	Performance check	Frequency	Frequency of calibration
Temperature recorder	Compare against thermometer	Daily	As necessary.
Refrigerated centrifuge	Observe speed and temperature	Each day of use	Do.
Hematocrit centrifuge			Standardize before initial use, after repairs or adjustments, and annually. Timer every 3 mo.
General lab centrifuge			Tachometer every 6 mo.
Automated blood-typing machine	Observe controls for correct results	Each day of use
Hemoglobinometer	Standardize against cyanmethemoglobin standard	......do
Refractometer	Standardize against distilled water	......do
Blood container scale	Standardize against container of known weight	......do	As necessary.
Water bath	Observe temperature	......do	Do.
Rh view box	......do	......do	Do.
Autoclave	......do	Each time of use	Do.
Serologic rotators	Observe controls for correct results	Each day of use	Speed as necessary.
Laboratory thermometers			Before initial use.
Electronic thermometers			Monthly.
Vacuum blood agitator	Observe weight of the first container of blood filled for correct results	Each day of use	Standardize with container of known mass or volume before initial use, and after repairs or adjustments.

(c) Equipment employed in the sterilization of materials used in blood collection or for disposition of contaminated products shall be designed, maintained and utilized to ensure the destruction of contaminating microorganisms. The effectiveness of the sterilization procedure shall be no less than that achieved by an attained temperature of 121.5 °C (251 °F) maintained for 20 minutes by saturated steam or by an attained temperature of 170 °C (338 °F) maintained for 2 hours with dry heat.

21 C.F.R. §606.60

40 FR 53532, Nov. 18, 1975; 40 FR 55849, Dec. 2, 1975, as amended at 45 FR 9261, Feb. 12, 1980; 57 FR 11263, Apr. 2, 1992; 57 FR 12862, Apr. 13, 1992