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
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