标准号：BS EN 1041:2008+A1:2013
标准名称：Information supplied by the manufacturer of medical devices（医疗器械制造商提供的信息）
标准格式：PDF
标准大小：2.48M
标准介绍：This European Standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical devices and Council Directive 93/42/EEC concerning medical devices. It doesnot specify the language to be used for such information,nor does it specify the means by which the information is to be supplied. It is also intended to complement the specific requirements of the cited EU Directives on medical devices by providing guidance on means by which certain requirements can be met. If a manufacturer follows these means, they will provide a presumption ofconformity with the relevant Essential Requirements regarding information to be supplied.
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