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发布时间: 2018-01-31 13:51:54   审校:睿智   浏览次数:



ISO关于避孕套的工作是由ISO/TC 157技术委员会非内吸性避孕产品和STI(性传播感染)屏障避孕工具负责。该技术委员会制定的标准旨在保证避孕套尺寸合适,没有破洞,足够强韧,使用时不会裂开,在储存过程中完整包装,以达到保护的目标,并要正确地贴上标签。技术委员会还为使用避孕套的人提供基本信息,包括使用说明。


使用避孕套也能避免感染其它病毒,尤其是丙型肝炎,这是一种能破坏人类肝脏的疾病。为了将病毒传播的风险降至最低,ISO/TC 157制定了一个新的测试方法,以确认材料的阻隔性能。

ISO工作小组成员比尔·波特(Bill Potter)说:“制造商必须确保避孕套完好,能够有效阻止病毒传播,”接着补充道,校验新的或改良后的避孕套产品时,必须从三批产品中抽取样本进行检测。关于女用避孕套检测,详情请参见ISO 25841:2017(以及较早的2011年和2014年版本),以及 ISO 23409:2011关于由合成材料制成的男用避孕套。

ISO/TC 157负责的大部分产品都属于医疗器材,从一次性男用避孕套到有多种用途、可以提供长久保护的女用宫内节育器。该组正在制定这些标准,现由ISO在马来西亚的成员——马来西亚标准组织(DSM)负责该小组秘书处的工作。



Highlighting the importance of standards on World Aids Day

Today is World AIDS Day, a day to show support for people living with HIV, the Human Immunodeficiency Virus. It’s also a day to raise awareness about condom safety.

Condoms are highly effective in providing protection against HIV, that attacks the body’s immune system and can lead to AIDS, according to the World Health Organization (WHO). And to make sure that condoms indeed function in this capacity, they are manufactured and tested to the highest ISO standards to ensure that they don’t break or leak when used.

ISO’s work on condoms is carried out by technical committee ISO/TC 157 on non-systemic contraceptives and STI barrier prophylactics. The standards it develops aim to ensure that condoms fit properly, are free from holes, have adequate physical strength so as not to rip during use, are adequately packaged for protection during storage and are correctly labelled. They also give essential information for the condom user, including instructions for use.

For it to be effective, the quality of the condom is very important. Before any production, the raw material, the latex, already undergoes quality tests. Next, tests are carried out on random individual specimens from each batch. A batch typically represents 150 000 condoms under just one series number.

Condoms also protect from various viruses, not least hepatitis C, a liver-destroying disease. To minimize the risk of viral transmission, ISO/TC 157 has developed a new test procedure for confirming the barrier properties of materials.

“Manufacturers are required to confirm that these condoms are effective viral barriers,” explains Bill Potter from the ISO working group. He adds that the testing of condoms is done from three production lots during the validation stage for any new or modified products. Details of the tests are included in ISO 25841:2017 for female condoms (and the earlier 2011 and 2014 editions) and ISO 23409:2011 for male condoms made from synthetic materials.

Most of the products under the responsibility of ISO/TC 157 are classified as medical devices, and range from the single-use male condom to multiple-use female intra-uterine devices that provide long-term protection. These standards are being developed by ISO/TC 157, whose secretariat is currently held by DSM, the ISO member for Malaysia.

World AIDS Day is held on 1 December each year. It is an opportunity for people worldwide to unite in the fight against HIV, commemorate those who have passed on and celebrate how far we have come in conquering this deadly disease.

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