Product |
Active implantable medical devices |
Rev. |
18/12/2020 |
Scope of |
Directive 1990/385/CEE of 20/06/1990
Directive 2007/47/EC of 5 September 2007
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Scope of application |
Applies to active implantable medical devices. The active medical device is connected for its operation to a source of electrical energy or to any other source of electrical energy or to any other source of energy other than that produced directly by the human body or by gravity. Active implantable medical device is any active medical device intended to be fully or partially implanted by surgical or medical intervention in the human body or by medical intervention in a natural orifice and intended to remain there after surgery
amending Council Directive 90/385 / EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42 / EEC relating to medical devices, and Directive 98/8 / EC relating to placing on the market of biocidal products
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Legislative Decree |
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Ministerial Decree |
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Main Voluntary Technical Standards |
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Contatts |
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Keywords |
Active implantable medical devices
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