ISO 23409 Male Condoms - Requirements and Test Methods for Condoms Made from Synthetic Materials

The standard “ISO 23409 Male condoms - Requirements and test methods for condoms made of synthetic materials” published by the International Organization for Standardization (ISO) describes the minimum requirements and test methods applicable to male condoms manufactured from synthetic materials or blends of synthetic materials and natural rubber latex used for contraceptive purposes and to help prevent sexually transmitted infections.

For the purposes of this standard, in addition to the terms and definitions given in “DIN ISO 2859-1 Sampling procedures for inspection according to specifications - Part 1: Sampling schemes indexed to the acceptance quality limit (AQL) for batch inspection”, the following definitions apply:

• The acceptance quality limit refers to the quality level that is the worst tolerable process average when a continuous series of batches are presented for acceptance sampling.
• The male condom is a medical device designed to cover and hold the penis during sexual activity, used by consumers for contraception and prevention of sexually transmitted infections.
• The expiration date is the date after which a condom is no longer suitable for use.
• An identification number is a number or combination of numbers, symbols or letters used by a manufacturer on consumer packages to uniquely identify the batch numbers of individual condoms contained in that package, making it possible to trace those batches through all stages of production, packaging and distribution.
• The individual container is the primary package containing a single condom.
• Inspection level is the relationship between lot size and sample size.
• A lot is a collection of condoms of the same design, color, shape, size and formula, produced at essentially the same time, using the same process, raw materials of the same specifications and common equipment, and packaged in the same type of individual container with the same lubricant and any additives.
• Lot testing is the test applied to evaluate the suitability of the lot.
• A hidden hole is a hole in a condom that is not visible under normal or corrected vision, but is detected by an appropriate water leak test or electrical test.
• A visible hole is a hole in a condom that can be seen under normal or corrected vision when testing for holes when the condom is filled with water or electrolyte.
• Synthetic material is any base material other than 100 percent natural rubber latex used in making condoms. The term applies to both condoms made entirely from synthetic materials and condoms made from blends of synthetic and latex.

Condoms are mass-produced products produced in very large quantities. Inevitably, there will be some variation between individual condoms and a small portion of condoms in each production run that may not meet the requirements of this standard. Furthermore, many of the test methods described in this standard are destructive. For these reasons, the only practicable method of assessing compliance with this standard is to test a representative sample from a lot or series of lots.

Basic sampling plans are included in ISO 2859-1. ISO/TR 8550 applies for guidance on the selection of an acceptance sampling system, scheme or plan for the examination of individual items in a batch.

When the quality of condoms needs to be continuously verified, it is recommended that the interested party also directs their attention to the manufacturer's quality system, rather than focusing solely on the evaluation of the final product.

Sampling plans should be selected to provide an acceptable level of consumer protection. Appropriate sampling plans are provided in the annexes to the standards (Annexes A and B).

Annex A describes sampling plans based on the ISO 2859-1 standard and is most suitable for manufacturers or purchasers assessing the conformity of a continuing batch series. The current level of full consumer protection is based on a transition to strict control if deterioration in quality is detected. Transitional rules cannot provide full protection for the first two batches tested, but become increasingly effective as the number of batches in a batch increases. These sampling plans are recommended when five or more batches are tested.

Annex B describes sampling plans based on the ISO 2859-1 standard recommended for the evaluation of isolated lots. These sampling plans, when used in conjunction with the transition rules, provide approximately the same level of consumer protection as those given in Annex A. It is recommended that these sampling plans be used for the evaluation of fewer than five lots, for example, in dispute cases, for arbitration purposes, for type testing, for qualification purposes or for short runs of continuous lots.

Our organization has a strong staff that closely follows the developments in the world in the field of science and technology and constantly improves itself. Among the numerous test, measurement, analysis and evaluation studies provided for businesses in various sectors, there are also test services in accordance with the standard “ISO 23409 Male condoms - Requirements and test methods for condoms made of synthetic materials”.