F1ANNEX II
2.REQUIREMENTS FOR CHECKING BATCHES OF PREPACKAGES
2.2.Checking of the actual contents of a prepackage
2.2.1.Non-destructive testing
Non-destructive testing shall be carried out in accordance with a double sampling plan as shown in the table below:
The first number of prepackages checked shall be equal to the number of units in the first sample, as indicated in the plan:
if the number of defective units found in the first sample is less than or equal to the first acceptance criterion, the batch shall be considered acceptable for the purpose of this check,
if the number of defective units found in the first sample is equal to or greater than the first rejection criterion, thebatch shall be rejected,
if the number of defective units found in the first sample lies between the first acceptance criterion and the first rejection criterion, a second sample shall be checked, the number of units in which is indicated in the plan.
The defective units found in the first and second samples shall be added together and:
if the aggregate number of defective units is less than or equal to the second acceptance criterion, the batch shall be considered acceptable for the purpose of this check,
if the aggregate number of defective units is greater than or equal to the second rejection criterion, the batch shall be rejected.
Number in batch | Samples | Number of defective units | |||
---|---|---|---|---|---|
Order | Number | Aggregate number | Acceptance criterion | Rejection criterion | |
100 to 500 | 1st | 30 | 30 | 1 | 3 |
2nd | 30 | 60 | 4 | 5 | |
501 to 3 200 | 1st | 50 | 50 | 2 | 5 |
2nd | 50 | 100 | 6 | 7 | |
3 201 and over | 1st | 80 | 80 | 3 | 7 |
2nd | 80 | 160 | 8 | 9 |
Substituted by Commission Directive of 28 September 1978 adapting to technical progress the Annexes to Council Directives 75/106/EEC and 76/211/EEC on prepackaging (78/891/EEC).