Chemicals Regulation Directorate, Health and Safety Executive, Bootle, Merseyside, UK.
J Hosp Infect. 2011 Mar;77(3):189-92. doi: 10.1016/j.jhin.2010.09.036. Epub 2010 Dec 30.
Disinfectants (including sporicides) used in the healthcare setting fall within the scope of the European Biocidal Products Directive (98/8/EC). The active substances used in these products will be evaluated as part of an EU wide review programme, to determine whether they can be used in biocidal products without undue risks to humans, animals and the environment, and that these products will be effective. Following the review of an active substance, biocidal products containing the active substance will become subject to regulatory controls in all EU Member States. This paper discusses how the Directive operates, both through the review programme and the authorisation of biocidal products at the Member State level, together with the requirements to provide data on the efficacy of both the active substances and end-use biocidal products.
用于医疗保健环境的消毒剂（包括杀孢子剂）属于欧洲生物杀灭产品指令（98/8/EC）的范围。这些产品中使用的活性物质将作为欧盟范围内审查计划的一部分进行评估，以确定它们是否可以在不对人类、动物和环境造成不当风险的情况下用于生物杀灭产品，并且这些产品将是有效的。在对一种活性物质进行审查后，含有该活性物质的生物杀灭产品将在所有欧盟成员国受到监管控制。本文讨论了指令如何通过审查计划以及在成员国一级对生物杀灭产品进行授权来运作，以及提供关于活性物质和最终用途生物杀灭产品功效的数据的要求。
