The story of the ‘OK’ Quality Seal, what its criteria are – and why it guarantees the safest condoms.
In order to obtain the ‘OK’ Quality Seal, manufacturers must agree to have every batch (production unit) tested by an independent laboratory to ensure that it meets the more stringent requirements of the Association for the Condom Quality Seal and to submit the test results to the Association.
No condom is 100% effective, but condoms with the ‘OK’ Quality Seal are the safest on the market.
Dr. Johannes Gauglhofer
All requirements for manufacturers are set out in the ‘Regulations for the Condom Quality Seal’. Manufacturers are contractually obliged to comply with these requirements and, in return, they are granted the right to use the ‘OK’ Quality Seal on their products.
Each production unit (batch) must meet the Association’s strict requirements in the burst test. In contrast to the international standard, the tested condoms do not have to reach a minimum volume during the burst test, but rather are classified as ‘poor’ if the burst volume deviates too greatly from the average value of the corresponding batch.
Manufacturers may only be awarded the ‘OK’ Quality Seal if they have had the burst test carried out by an independent laboratory. This is in contrast to the requirements for the CE mark, which also allow internal quality testing.
If manufacturers are producing continuously for the Swiss market (or for the ‘OK’ Quality Seal), each batch must pass a burst test before it can be sold. In addition, the test laboratory must send the results directly to the Association before distribution. This also applies to the results of batches that have failed the test.
In the burst test, individual condoms from a random sample are inflated until they burst. The burst volume and burst pressure are measured at the moment of bursting. After examining the whole sample, the laboratory determines the batch’s average burst pressure and volume, and condoms that do not reach at least 75% of this value are classified as ‘non-compliant’. If there are too many ‘non-compliant’ condoms in a sample, the batch fails the burst test and may not be sold in Switzerland.
| The ‘OK’ Quality Seal has existed since 1990 and is registered as a trademark at the Intellectual Property Office. Manufacturers must meet strict conditions in order to use it. But it’s worth it – because the ‘OK’ Quality Seal certifies that the condom has undergone rigorous testing and is of very good quality. And since it is so well known amongst consumers, it is an important sign of trust. |
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Dr Johannes Gauglhofer is a pioneer in the field of quality assurance for condoms.
‘During the sexual revolution of the 1970s, which saw the new generation exploring themselves and their sexuality, nobody was talking about good or bad condoms. In fact, nobody in Switzerland or anywhere else was really talking about condoms at all: Men avoided them at all costs, and only a few women insisted on them as a means of contraception – if they dared to do so’, says Johannes Gauglhofer.
In the late 1970s, a Danish businessman wanted to bring condoms to the Swiss market. Since, in his home country, condoms were subject to materials testing, he contacted EMPA, the Swiss Federal Laboratories for Materials Science and Technology, in St. Gallen. Johannes Gauglhofer, then Head of the Leather and Footwear Department at EMPA, began researching this field, which had previously been uncharted territory in Switzerland. He came across the test method used in Sweden, whereby condoms are inflated by a machine until they burst.
‘The burst test identifies the weakest point of the rubber – that is, wherever the material is too thin or where a hole has destroyed the condom’s protective function,’ explains Gauglhofer. A corresponding machine was developed and the Swiss testers set out the test requirements. ‘We determined what was known as the ‘burst volume’ by inflating condoms until they burst and timing them with a stopwatch – and startling ourselves in the process. Using this measurement method we’d developed ourselves, we discovered the catastrophic quality of condoms on the Swiss market, but nobody really cared. Condoms weren’t exactly a smash hit at the time,’ says Gauglhofer with a smile.
The situation changed abruptly in the 1980s. With the emergence of AIDS, people were suddenly recognising the importance of tear-resistant condoms for the prevention of sexually transmitted diseases: At that time, a hole in the rubber or – even worse – a torn condom could be fatal. Federal government education campaigns, including the famous ‘Gummi Song’ which is still well known today, helped to increase social acceptance of condoms among the general public.
The Stiftung Konsumentenschutz (Foundation for Consumer Protection) then had condoms tested at the EMPA, and the use of the condom testing machine really took off. The results were once again unsatisfactory – only two providers met the requirements. This time, however, unlike after the first series of tests, the results were met with outrage. The Federal Office of Public Health also stepped in. There was some debate around standards for condoms and legal requirements, but these were considered to be trade barriers to imports.
This in turn led to the establishment of the Association for the Condom Quality Seal in 1989. To this day, the Association only awards the ‘OK’ Quality Seal, which is well known throughout Switzerland, to products that pass the laboratory tests and meet the stringent requirements.
Source: Swiss Association for Standardization (SNV). SNV Story No. 4: Association for the Condom Quality Seal
The first tests are carried out at EMPA (Swiss Federal Laboratories for Materials Science and Technology)
Enquiries from consumer organisations in connection with AIDS
The Foundation for Consumer Protection publishes a comparative test
The STOP AIDS campaign is launched on 2 February 1987.
The Swiss standard for condoms made from natural rubber latex is published. The implementation of this standard is voluntary for companies.
The first ‘OK’ Quality Seal for condoms is created
The ‘OK’ Quality Seal for condoms is definitively created
Swiss ordinance on condoms
European Standard EN 600 ‘Natural rubber latex male condoms’
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Switzerland adopts the European standard, which then enters into force via the Medical Devices Ordinance.
‘Safe condoms’ logo
Regulations for ‘safe-for-condoms’ lubricants
The harmonised SN EN ISO 4074 standard replaces EN 600 and is therefore also enters into force in Switzerland via the Medical Devices Ordinance. This forms the basis of the CE mark. Condoms without the CE mark may not be sold in Switzerland.