AS 5074-2009 pdf download.Natural Latex Rubber Condoms – Requirements And Test Methods.
AS 5074 specifies the minimum requirements and the test methods to be used for condoms made from natural rubber latex which are supplied to consumers for contraceptive purposes and to assist in the prevention of sexually transmitted infections.
2 Normative references
ISO 188, Rubber, vulcanized or thermoplastic — Accelerated ageing and heat resistance tests
ISO 2859-1:1999, Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed by acceptance quality limit (AOL) for lot-by-lot inspection.
3.1
acceptable quality limit
AOL
When a continuous series of lots is considered, the quality level which for the purposes of sampling inspection is the limit of a satisfactory process mean (according to Iso 2859-1)
3.2
condom
medical device used by consumers, which is intended to be retained on the penis during sexual activity, for purposes of contraception and prevention of sexually transmitted infections
NOTE If a consumer could responsibly consider a device to be a condom (due to its shape, packaging, etc.), it is considered a condom for the purpose of this International Standard.
3.3
consumer package
package, intended for distribution to a consumer, containing one or more individual containers
3.5
identification number
number, or combination of numerals, symbols or letters used by a manufacturer on consumer packages to identify uniquely the lot numbers of individual condoms contained in that package, and from which it is possible to trace those lots through all stages of packaging and distribution
NOTE When the consumer package contains only one kind of condom, then the identification number may be the same as the lot number. But if the consumer package contains several different types of condom, for instance condoms of different shapes or colours, then the identification number will be different from the lot number.
3.6
individual container
immediate wrapping of a single condom
3.7
inspection level
relationship between lot size and sample size.
NOTE For description, see ISO 2859-1:1999, 10.1.
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.AS 5074 pdf download.