ISO Standards

ISO, whose full name is the "International Organisation for Standardisation", is an independent, non-governmental international organisation composed of representatives from over 170 countries and regions. Since its establishment in 1946, ISO has developed over 26,000 international standards.

ISO standards are international consensus standards developed by experts worldwide.

Think of them as a standardised formula that describes the "best way of doing something". They cover a wide range of activities, from manufacturing products and managing processes to delivering services and supplying materials, helping businesses and organisations operate and produce in the most effective way possible.

Every ISO standard is shaped by experts who know their fields inside out. Hailing from all corners of the globe, they may be manufacturers, sellers, buyers, customers, trade associations, users, or regulators, ensuring a deep understanding of industry realities and what users truly need.

Over the years, ISO standards have been adopted by countless industries worldwide, steadily raising the quality and efficiency of products and services.

ISO has a wide variety of standards. Here are some examples:

• Quality management standards: Improve operational efficiency and reduce errors and defects in production
• Environmental management standards: Reduce environmental impact, cut pollution and waste, and support sustainability
• Occupational health and safety standards: Lower the risk of workplace accidents
• Energy management standards: Help reduce energy consumption
• Food safety standards: Prevent food contamination
• Information security standards: Protect sensitive information from threats and leaks

International standards ensure that the products and services you use every day are safe, reliable, and of high quality. They also guide businesses in adopting sustainable and ethical production methods, allowing you to make informed choices and enhancing your overall experience with products and services.

To keep ISO standards up to date and relevant, ISO holds annual meetings that bring together leading standards bodies, industry leaders, policymakers, and international experts from around the world. This professional international platform focuses on the latest global trends of technological and industrial development. The meeting plays a vital role in shaping the future direction of standardisation, fostering knowledge exchange, and reviewing ISO’s technical strategies. Through collaboration and consensus-building, the annual meeting continuously strengthens the global credibility and impact of ISO standards.

Yes, they do! To ensure ISO standards remain relevant and effective, the International Organisation for Standardisation regularly reviews existing standards and carries out large-scale updates when necessary. This process is called "Revision". It involves thousands of global experts, public consultations and rigorous review procedures.

Once the revision is completed, a new version of the standard is published. The new version improves existing content, removes outdated requirements, and may introduce new ones, keeping the standard up-to-date with modern technology, market needs and scientific advancements.

Just like how we mark documents as “Version 1” or “Version 2”, ISO standards use the year of publication to indicate different versions.

For example, with ISO 4074:

• The version published in 2014 is named "ISO 4074:2014"
• The version published in 2015 is named "ISO 4074:2015"

The newer the year, the more recent the version.

After a new version is officially published, manufacturers and companies are given a buffer period to implement the changes and adapt to the new requirements. This period is called "Transition".

The transition period is generally 3 years. During this time, the previous version is still accepted. Manufacturers and companies can gradually update their processes, documentation, and product testing methods before fully transitioning to the latest standard by the end of the transition period.

Our latex condoms comply with ISO 4074:2015, the international safety standard for natural rubber latex male condoms, while our polyurethane (PU) condoms comply with ISO 23409:2011, the international safety standard for male condoms made from synthetic materials.

ISO 4074 is an international standard developed by ISO that specifies the requirements and test methods for male condoms made from natural rubber latex.

This standard ensures that natural rubber latex male condoms are safe, reliable, and effective for contraception and protection against sexually transmitted infections (STls) such as HIV/AIDS. It is reviewed every five years to incorporate the latest scientific evidence, address emerging technological advancements, and maintain its relevance and alignment with evolving regulatory and public health requirements.

ISO 4074 evaluates the quality of condoms through a series of rigorous tests, including:

Physical & Mechanical Performance Tests

• Bursting Test : It is to measure the condom strength. Keep the condom inflated until it bursts and the bursting pressure will be measured, which implies the amount of force that the condom can withstand. The minimum standards for bursting volume and bursting pressure are 18 dm³ and 1.0 kPa, respectively
• Tensile Test : It is also to measure the condom strength. Slice a band from the shaft of the condom and stretches until it breaks. The force required to break the condom and the amount of elongation at breakage will be measured

Integrity Tests (Freedom from Holes)

• Water Leak Test (Electrical Conductivity Test) : Condoms are filled with water and inspected for leaks using electrical detection
• Water Leak Test (Hanging Test) : It is to detect the pinholes on the condom. It involves filling a condom with water and visually checking for leaks
• Water Leak Test (Rolling Test) : It involves the hanging condom used in the previous test. Tie its base and roll it over the absorbent paper with hand pressure. Any stains on the absorbent paper will imply that there are pinholes on the condom. It is possible to discover holes that the previous test cannot detect

ISO 4074 is a well-established and mature international standard with a long history. Since its first publication in 2002, it has evolved through multiple editions. The current latest version is the 4^th edition, published in 2026.

ISO 23409 is an international standard developed by ISO that specifies the minimum requirements and the test methods applicable to male condoms produced from synthetic materials or blends of synthetic materials and natural rubber latex.

The test methods are largely aligned with those of ISO 4074. Through a series of rigorous assessments, the standard evaluates the quality of condoms to ensure their safety, reliability, and effectiveness in contraception and protection against sexually transmitted infections (STls) such as HIV/AIDS. The standard is reviewed every five years to ensure it reflects the latest scientific research, technological developments, and evolving regulatory and public health needs.

18 dm³ Bursting Volume (18 Litres)
Latex condoms that pass the burst test must be able to hold up to 18 litres of air without bursting. That’s roughly equivalent to the volume of 9 standard 2-litre soda bottles, which is enough to fill a small kitchen rubbish bin.

1.0 kPa Bursting Pressure
After being inflated with 18 litres of air, a passing latex condom must still withstand at least 1.0 kPa of internal pressure without bursting. To give you a sense of the force: 1.0 kPa is like having a 10 kg weight pressing down on the area of your palm (about 10 × 10 cm).

In other words, latex condoms that meet the ISO 4074 standard can handle being inflated into a "balloon big enough to hold 9 large soda bottles" while enduring the pressure equivalent to a "10 kg weight on your hand" and still not burst.

ISO does not directly evaluate or measure the contraception rate of condoms. Instead, ISO 4074 and ISO 23409 focus on establishing the best possible manufacturing conditions and quality controls to produce reliable condoms. When a condom fully meets all the requirements of these standards, it demonstrates that the product has been made to a consistently high level of quality, making it dependable for effective contraception as well as helping to prevent HIV/AIDS and other sexually transmitted infections (STIs) when used correctly.

The most common method for measuring the effectiveness of different contraceptive methods is the Pearl Index. Developed by American biologist Raymond Pearl in 1933, this index calculates the number of unintended pregnancies per 100 women using a particular contraceptive method over one year.

Pearl Index = (Number of pregnancies × 12) × 100 ÷ (Number of women in the study × Duration of study in months)

The lower the Pearl Index, the more reliable the contraceptive method.

(Example: If a condom has a Pearl Index of 13, this means that out of 100 women relying on that condom as their primary method of contraception for one year, 13 will become pregnant.)

The Pearl Index is further divided into two distinct indicators: Perfect-use and Typical-use.

Perfect-use vs. Typical-use

• Perfect-use : Refers to the effectiveness of a contraceptive method over one year when used correctly and consistently during every act of intercourse. Male condoms have a perfect-use contraception rate of approximately 98%*
• Typical-use : Reflects real-world effectiveness, accounting for human error (e.g., not using the condom throughout intercourse, incorrect application, or reuse). Male condoms have a typical-use contraception rate of approximately 87%*

Important note: No methods can currently guarantee 100% protection. However, condoms are the only method that can effectively provide both contraception and protection against sexually transmitted infections (STIs) such as HIV/AIDS at the same time.