Document ID: chunk:federal_register_of_legislation:F2005L03990:reg:60:p6
Version: federal_register_of_legislation:F2005L03990
Segment Type: reg
Provision Reference: reg 60 (pt 6/9)
Character Range: 81828–84423

impactor shall strike the tibia so that the horizontal centre line of the impactor falls within 0,5° of a horizontal line parallel to the femur load cell simulator at time-zero. The impactor shall be guided to exclude significant lateral, vertical or rotational movement at time-zero .
1.3.6.  Allow a period of at least 30 minutes between successive tests on the same leg.
1.3.7.  The data acquisition system, including transducers, shall conform to the specifications for CFC 600, as described in annex 8.
1.4.  Performance specification
1.4.1. When each tibia is impacted at 2.1  0,3 m/s in accordance with paragraph 1.3., the impact force, which is the product of the pendulum mass and the deceleration, shall be 2.3  0,3 kN.

2.  UPPER FOOT IMPACT TEST
2.1.  The objective of this test is to measure the response of the Hybrid III foot and ankle to well-defined, hard-faced pendulum impacts.
2.2.  The complete Hybrid III lower leg assembly, left (86-5001-001) and right (86-5001-002), equipped with the foot and ankle assembly, left (78051-614) and right (78051-615), shall be used, including the knee assembly. The load cell simulator (78051-319 Rev A) shall be used to secure the knee-cap assembly (78051-16 Rev B) to the test fixture.
2.3.  Test procedure
2.3.1.  Each leg assembly shall be maintained (soaked) for 4 hours prior to the test at a temperature of 22  3°C and a relative humidity of 40  30 per cent. The soak period shall not include the time required to reach steady state conditions.
2.3.2. a) Clean the impact surface of the skin and also the impactor face with isopropyl alcohol or equivalent prior to the test.
 b) Align the impactor accelerometer with its sensitive axis parallel to the direction of impact at contact with the foot.
2.3.3.  Mount the leg assembly to the fixture shown in Figure 1a. The test fixture shall be secured rigidly to prevent movement during the impact test. The centre line of the femur load cell simulator (78051-319) shall be vertical  0,5°. Adjust the mount such that the line joining the knee clevis joint and the ankle attachment bolt is horizontal  3° with the heel resting on two sheets of low-friction (PTFE) material. Ensure that the tibia flesh is located towards the knee end of the tibia. Adjust the ankle such that the plane of the underside of the foot is vertical  3°. Adjust the knee and ankle joint to 1,5  0,5 g range before each test.
2 3.4.  The rigid impactor comprises a horizontal cylinder diameter 50  2 mm and a pendulum support arm diameter 19  1 mm (Figure 3a). The cylinder has a mass of 1,25  0,02 kg