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Framework for clinical evaluation of devices for adult male circumcision
世界卫生组织成年男性包皮环切器械临床评估框架文件

Framework for clinical evaluation of devices for adult male circumcision

February 2011


7 March 2011

Framework for Clinical Evaluation of Devices for Adult Male Circumcision

The purpose of this document is to provide a framework for the clinical assessment of male circumcision devices for adult male circumcision in programs to expand male circumcision for HIV prevention. The document gives background on male circumcision and why it is recommended for HIV prevention. Next, it presents a review of the potential for male circumcision devices (once shown to be acceptable, safe and effective in the target population) to facilitate rapid expansion of adult male circumcision services in resourcelimited settings. This is followed by a summary of different medical device regulatory systems with special reference to male circumcision devices in the country of origin, the country of use of the device, as well as considerations for sponsors of research and/or programmes.

Source: WHO (http://www.who.int/hiv/pub/malecircumcision/framework_devices/en/index.html)
 
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