Natural latex rubber condoms- Requirements

Natural latex rubber condoms- Requirements (abstract from ISO 4074:2002)

1、Terms and definitions

1.1 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 sexual transmitted infections.

1.2 Acceptable quality limit AQL

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.

1.3 Consumer package

Package, intended for distribution to a consumer, containing one or more individual containers.

1.4 Expiry date

Stated date after which a condom should not be used.

1.5 Identification number

Number, or combination of numerals, symbols or letters used by a manufacturer on consumer package to identify uniquely the lot number of individual condoms contained in that package, and from which it is possible to trace those lots through all stages of packaging and distribution.

1.6 Individual container

Immediate wrapping of a single condom.

1.7 Inspection level

Relation between lot size and sample size.

1.8 Lot

Collection of condoms of the same design, colour, shape, size and formulation, manufactured at essentially the same time, using the same process, raw materials of the same specifications, common equipment and packed with the same lubricant and any other additive or dressing in the same type of individual container.

1.9 Lot number

Number of combination of numerals, symbols or letters used by the manufacturer to identify a lot of individually packaged condoms, and from which it is possible to trace that lot through all stages of manufacture up to packaging.

1.10 Lot test

Test to assess the compliance of a lot.

1.11 Non-visible hole

Hole in the condom that is not visible under normal or corrected vision but is detected by leakage when rolling on absorbant paper.

1.12 Sampling plan

Specific plan which indicates the number of units of product from each lot which are to be inspected (sample size or series of sample sizes) and the associated criteria for determining the acceptability of the lot (acceptance and rejection numbers)

1.13 Shelf life

Time from date of manufacture to the claimed expiry date.

1.14 Visible hole

Hole or tear in the condom that is visible under normal or corrected vision.

2 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.

3 Design

3.1 Integral bead

The open end of the condom shall terminate in an integral bead.

3.2 Dimensions

3.2.1 Length

Taking 13 condoms from each lot, no individual length measurement shall be below 160mm.

3.2.2 Width

Taking 13 condoms from each lot, no width measurement shall deviate from the nominal width stated by the manufacturer by more than±2mm.

3.2.3 Thickness

If the thickness of the condom is specified, then it shall be determined by the method in annex F.

4 Burst volume and pressure

4.1 Untreated condoms

The bursting pressure shall be not less than1.0 kPa and the bursting volume shall be not less than:

—6.0dm3 for condoms with a width less than 50.0mm, or

—18.0 dm3 for condoms with a width greater than or equal to 50.0mm and up to 56.0 mm, or

—22.0 dm3 for condoms with a width greater than or equal to 56.0mm

The width is defined as the mean flat width of 13 condoms measured at a point (75±5) mm from the closed end.

The compliance level for each lot shall be an AQL of 1.5 for non-conforming condoms.

A non-conforming condom is defined as a condom that fails the requirement for volume, pressure, or both, or any condom that exhibits any leakage.

5 Freedom from holes

The compliance level for each lot, for the sum of condoms with visible and non-visible holes and tears, shall be an AQL of 0.25.

6 Visible defects

The compliance level for each lot, for the condoms with visible defects, namely a broken, missing or severely distorted rim and permanent creases with adhesion of the film, shall be an AQL of 0.4.

7 Package integrity

Refers to the possibility of breaches in sealed individual condom containers that may result in the leakage of lubricant. Such breaches will also cause the package to be permeable to oxygen. The compliance level for each lot shall be AQL of 2.5.

8 Sampling plans and acceptance criteria for a continuing series of lots