AS 5074:2009 pdf free download – Natural latex rubber condoms – Requirements and test methods
4 Quality verification
Condoms are mass-produced articles manufactured in very large quantities. Inevitably there will be some variation between individual condoms, and a small proportion of condoms in each production run may not meet the requirements in this International Standard. Further, the majority of the test methods described in this International standard are destructive. For these reasons the only practicable method of assessing compliance with this International Standard is by testing a representative sample from a lot or series of lots. Basic sampling plans are given in ISO 2859-1 . Reference should be made to ISO/TR 8550 for guidance on the selection of an acceptance sampling system, scheme or plan for the inspection of discrete items in a lot. When on-going verification is required of the quality of condoms, it is suggested that, instead of concentrating solely on evaluation of the final product, the party concerned also directs his attention to the manufacturer’s quality system. In this connection it should be noted that the ISO 9000 series (see Bibliography) covers the provision of an integrated quality system. Sampling plans shall be selected to provide an acceptable level of consumer protection. Suitable sampling plans are given in annexes A and B.
a) Annex A describes sampling plans based on ISO 2859-1 and is most applicable to manufacturers or purchasers assessing the compliance of a continuing series of lots. The full level of consumer protection available depends upon the switch to tightened inspection if a deterioration in quality is detected. The switching rules cannot offer full protection for the first two lots tested, but become progressively more effective as the number of lots in a series increases. The sampling plans in annex A are recommended when five or more lots are being tested.
b) Annex B describes sampling plans, based on ISO 2859-1 , that are recommended for the assessment of isolated lots. The sampling plans in annex B provide approximately the same level of consumer protection as those given in annex A when used with the switching rules. It is recommended that these sampling plans be used for the assessment of fewer than five lots, for example in cases of dispute, for referee purposes, for type testing, for qualification purposes or for short runs of continuing lots.
c) Handling and storage conditions shall be documented before drawing the samples.
It is necessary to know the lot size in order to derive from ISO 2859-1 the number of condoms to be tested. The lot size will vary between manufacturers and is regarded as part of the process and quality controls used by the manufacturer.
5.3.2 Width
When tested by the method given in annex E, taking 1 3 condoms from each lot, no width measurement shall deviate from the nominal width stated by the manufacturer by more than . The width shall be measured at the narrowest part of the condom within from the open end, or at a point specified by the manufacturer within the same area. NOTE The width for determination of the requirements for burst volume as in 6.1 may be measured at the same time.