International Organization for Standardization

International Standards for Business, Government and Society

News > 2010 > On World AIDS Day, ISO highlights importance of condom standards

News

On World AIDS Day, ISO highlights

importance of condom standards

29 November 201 O

Condoms are widely

acknowledged to
reduce the risk of HIV Related information
infection. On World
ISO/TC 157 - Non-systemic
AIDS Day,
contraceptives and STI barrier
1 December, ISO
prophylactics
highlights the
importance of
developing and Related Ii nks
implementing
World Al DS Day
International Standards for condoms to ensure their effective
performance. Condom testing contributes to
disease prevention - ISO Focus,
ISO's work on condoms is carried out by ISO technical June 2009 (PDF, 190 Kb)
committee ISO/TC 157 on non-systemic contraceptives and
STI barrier prophylactics. The standards it develops aim to
ensure that condoms fit the penis properly, are free from
holes, have adequate physical strength so as not to break Media Contact
during use, are correctly packaged for protection during
storage and are correctly labeled. Katie
Bird
Most of the products under the responsibility of ISO/TC 157 Head
are classified as medical devices, and range from the single-
use male condom to multiple-use female intra-uterine
devices.

A key standard is ISO 4074:2002, Natural rubber latex

condoms - Requirements and test methods, which
provides the basis for much of the world's trade in condoms.
ISO 4074 is widely used by procurement agencies and HIV
Communication and Content
prevention and family planning agencies, and is referenced
extensively by the World Health Organization in its Strategies
purchasing specifications for condoms. ISO

+41 22 749 0431

"Over the past decade, manufacturers of latex condoms bird@iso.org
have continued to make product improvements based on
research and development findings, and on changes in ISO
4074, which is used in buyer's purchasing specifications,"
explains Dr. Eng Long Ong, Chair of ISO/TC 157, in an
~ on the subject published in /SO Focus magazine.

He adds that part of its success relies on the involvement of

all key stakeholders, "Given the need to protect public health
and safety, medical products are subject to stringent
regulations. Condom manufacturers must ensure that their
products meet regulatory requirements for efficacy, quality
and suitability. Regulators include the US Food and Drug
Administration, the European Commission and the
procurement specifications of donor agencies providing free
or low cost condoms. The involvement of regulatory
agencies in the work of ISO/TC 157 is essential."

ISO Secretary-General Rob Steele comments, "Millions of

people have died as a result of AIDS, and millions more
continue to live with HIV. One step for tackling this epidemic
is giving people access to information about how to prevent
contagion. But another equally important step is ensuring
that people can rely on this information. If condoms are to be
effective tools for responding to the epidemic, we must make
sure that low quality products do not enter the market. ISO
standards provide requirements based on internationally
agreed levels of performance, which are available to all
countries around the world. By complying with ISO
standards, manufacturers can demonstrate to consumers
and regulators that their products are fit for use."

World AIDS Day is organized annually on 1 December by

the World AIDS Campaign to raise awareness about the
epidemic, honour those who have died, draw attention to key
issues for a successful response and inspire positive action.
This year, the theme of the event is "Universal access and
human rights." UN Secretary-General Ban Ki-moon has
warned that many countries are seeing reduced access to
essential HIV information, prevention tools, treatments and
services, and has emphasized the important need to uphold
human rights as part of the response to tackling the
epidemic.

ISO Store

ISO 4074:2002
Natural latex rubber condoms -- Requirements and test methods

Visit the ISO__ Store to buy more standards