Tests

c)

Design not as specified. Not incompliance with applicable

codes and standards.

d)

Components not easy accessible for maintenance and

servicing. Safety devices not provided as specified.

e)

Controls and indicators missing or not as specified.

f)

Sterilizers not installed as specified.

h)

Power supply not as specified.

i)

Utilities including water, steam, drainage and air not

provided as specified.

j)

Metal used in fabrication not type specified. Has sharp

corners, burrs, dents, and deformities.

k)

Bolted connections not as specified. Missing stripped,

cross-threaded screws, bolts and nuts.

l)

Welded joints and seams are not grinded smooth to match

surfaces.

3)

Tests:

a)

Test Conditions:

(1)

Apparatus and instruments used for testing the

washer-sterilizer(s) should be so installed as not to

hinder accurate operation. The instruments should be

calibrated at least annually to assure laboratory

accuracy.

(2)

The tests should be conducted in an ambient

temperature maintained between 18 and 35 C (65 and

95 F).

b)

Test Load:

(1)

The sterilizer(s) should be loaded with two trays

containing 100 surgical instruments including

retractors, forceps, and hemostats.

(2)

A spore strip inoculated with a mixture of population

of bacillus stearothermophilus subtilus population

adjusted to surviving 120 C (250 F) for 20 seconds

and killed when exposed to 132 C (270 F) for 2

minutes, placed amid the instruments in each tray.

(3)

Install a thermocouple in the

washer-sterilizer-chamber-drain-line fitting; connect

the wire to a potentiometer.

c)

Washing and Sterilizing Test:

(1)

Program the controls for a complete wash and sterilize

cycle.

(2)

Actuate the cycle and record the time.

(3)

Actuate the potentiometer.

(4)

When the cycle-phase light indicates that the

sterilizing phase of the cycle has begun, record the

time.

(5)

Record the time when the end-of-cycle alarm first

sounds.

(6)

No more than 26 minutes should have elapsed between

the time that control was initially actuated for the

cycle and the time the end-of-cycle alarm sounded.

The potentiometer reading from the thermocouple in the

chamber-drain line should have been 132 C - 134 C

(270 F - 274 F) for not less than 3 minutes.

d)

Sterilizing Efficiency Test.

(1)

Place the instruments trays in the chamber of the

washer-sterilizer and program the controls for a 10

minute sterilizing cycle.

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