§ 610.22 — Device Integrity

The 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).