Section 610.22 - Device integrityThe integrity of a device will be evaluated with respect to:
(a) The extent to which device manufacture is standardized by means of drawings, specifications, and other fabrication and quality assurance controls;(b) The degree of sensitivity of device effectiveness to deterioration under exposure to normal operating conditions.(c) The susceptibility of the device to deterioration of effectiveness under abnormal operating conditions;(d) The effect upon its surroundings of device malfunction which may be reasonably anticipated to occur in actual use; and(e) The extent to which test data support (b), (c) and (d).