ESR has been testing Condoms on behalf of MEDSAFE for many years. It operates the only authorized condom-testing laboratory in New Zealand.
Condoms marketed in New Zealand must comply with ISO 4074:2002(E) standard. This standard allows for testing using the relevant single, dual or multiple sampling plans found in ISO 2859-1:1999(E).
Testing covers:
- Labelling and Packaging
- Holes
- Dimensions
- Burst Volume and Pressure
- Aged (oven treated) assessment
- Force at Break (applicable to condoms claiming “Extra Strength” properties only), and
- Thickness - if identified on packaging.
Both fresh and artificially aged (to approximate 5 years shelf life) condoms are tested by air inflation to destruction, for volume and pressure. To be sold in New Zealand minimum volumes at burst must not be less than 18 litres and the pressure not less than 1 kPa.
Condoms not complying with the standard are not released onto the New Zealand market.
ESR testing accounts for approximately 2 million condoms each year.
Quality
When testing began in the late 80’s, some condom brands had very high failure rates. The worst batch had holes in 9% of the condoms. A steady and noticeable improvement in quality has been apparent over the last few years, with today less than ½ of 1% failing.
Condoms are traditionally used as a method of contraception. As they are widely used as a method of protection. against STD’s and HIV in the community, there continues to be a strong need to continue testing programmes to assure their quality and maintain public confidence in the products.
Holes are detected by filling condoms with 300ml of water, allowing them to hang for 1 minute (minimum), and then, with the water still inside, hand rolling them under pressure as a final check for holes.