be based on monitoring of time and temperature at the base, the middle and at the top of the stockpile, with a representative number of monitoring points (at least four monitoring points in the basal zone, which are located at a maximum of 10 cm above the base and at a maximum of 10 cm below the top, one monitoring point in the middle half way between base and the top of stockpile, and four monitoring points in the marginal zone at the top of the pile, which are located at a maximum of 10 cm below the surface and at a maximum of 10 cm below the top of the stockpile);

An upper and lower limit test shall be obligatory in respect of preserving agents and an upper limit test for any other excipient component liable to affect adversely physiological functions; an upper and lower limit test shall be obligatory in respect of the excipient if it is liable to affect the bio-availability of an active substance, unless bio-availability is guaranteed by other appropriate tests.

An upper and lower limit test shall be obligatory in respect of preserving agents and an upper limit test for any other excipient constituent liable to affect adversely physiological functions; an upper and lower limit test shall be obligatory in respect of the excipient if it is liable to affect the bio-availability of an active substance, unless bio-availability is guaranteed by other appropriate tests.

An upper and lower limit test shall be obligatory in respect of preserving agents and an upper limit test for any other excipient constituent liable to affect adversely physiological functions; an upper and lower limit test shall be obligatory in respect of the excipient if it is liable to affect the bio-availability of an active substance, unless bio-availability is guaranteed by other appropriate tests.

// Examination of the stability of the properties of pressure gauges // // The tests consist in subjecting pressure gauges to: // // (a) a pressure exceeding the upper limit of the measuring range by 25 % for 15 minutes; // // (b) 1 000 pulses produced by a pressure varying from 0 to 90-95 % of the upper limit of the measuring range; // // (c) 10 000 cycles of a pressure varying slowly from approximately 20 % to approximately 75 % of the upper limit of the measuring range at a frequency not exceeding 60 cycles per minute; // // (d) an ambient temperature of - 20 °C for six hours and a temperature of + 50 °C for six hours.

The deductible, which is the first few hundred thousand dollars that the applicant pays, and more dangerously, the upper limit that would apply, would mean that the insurer would add the premium to the deductible, and in some cases the amount over the limit.