F1ANNEX II

Annotations:

2.REQUIREMENTS FOR CHECKING BATCHES OF PREPACKAGES

2.3.Checking of the average actual contents of the individual prepackages making up a batch

2.3.3.

Criteria for acceptance or rejection of the batch of prepackages for checking the mean:

2.3.3.1.

Criteria for non-destructive testing

Number in batch

Number in sample

Criteria

Acceptance

Rejection

100 to 500 (inclusive)

30

xQn — 0.503smath
x<Qn — 0.503smath

> 500

50

xQn — 0.379smath
x<Qn — 0.379smath

2.3.3.2.

Criteria for destructive testing

Number in batch

Number in sample

Criteria

Acceptance

Rejection

Whatever the number (≥100)

20

xQn — 0.640smath
x<Qn — 0.640smath