It is intended for users of. This European Standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90385EEC relating to active implantable medical devices and Council Directive 9342EEC concerning medical devices.
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Information supplied by the manufacturer of medical devices. 1 medical device means any instrument apparatus appliance software implant reagent material or other article intended by the manufacturer to be used alone or in combination for human beings for one or more of the following specific medical purposes. Viele übersetzte Beispielsätze mit information supplied by the manufacturer with medical device Deutsch-Englisch Wörterbuch und Suchmaschine für Millionen von Deutsch-Übersetzungen. This document includes the generally applicable requirements for identification and labels on a medical device or accessory the packaging marking of a medical device or accessory and accompanying information.
Written printed or graphic information provided upon the medical device itself. Annex C informative Reference to the IMDRF essential principles and labelling guidance. Harmonized EN 10412008 replaces EN 10411998.
Information supplied by the manufacturer with medical device - Deutsch-Übersetzung Linguee Wörterbuch. This document specifies the requirements for information supplied by the manufacturer for a medical device or by the manufacturer for an accessory as defined in 31. Labeling includes the label instructions for use and information 42 related to the identification technical description intended purpose and proper use of the 43 medical device and IVD medical device as applicable Figure 1.
Information supplied by the manufacturer with medical devices Irish Standard IS. This standard aims to provide a central source of the common generally applicable requirements. 10 Information supplied by the manufacturer.
Medical devices Information to be supplied by the manufacturer - nears completion. This is a free 6 page sample. Annex A informative Particular guidance and rationale.
Access the full version online. Describes requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90385EEC relating to active implantable medical devices and Council Directive 9342EEC concerning medical devices. Written printed or graphic information marked on the item itself or on the packaging of each item or on the packaging of multiple items.
Sector of EN 10412008. ISO 18113-12009 defines concepts establishes general principles and specifies essential requirements for information supplied by the manufacturer of in vitro diagnostic. It does not specify the language to be used for such information nor does it specify the means by which the information is to be.
This European Standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90385EEC relating to active implantable medical devices and Council Directive 9342EEC concerning medical devices. Information supplied by the manufacturer that is provided for associated with or affixed to a. EN 10412008 NSAI 2008 No copying without NSAI permission except as permitted by copyright law.
AIMD Active implantable medical devices MDD Medical devices. ISO 20417 sets out requirements for the identification marking and labels on a medical device or accessory and the information necessary to accompany the device or accessory. In some jurisdictions Labeling is referred to as Information 41 Supplied by the Manufacturer.
Information supplied by the manufacturer of medical devices Informations fournies par le fabricant de dispositifs médicaux Bereitstellung von Informationen durch den Hersteller von Medizinprodukten This European Standard was approved by CEN on 4 July 2008. CEN andCENELEC members are bound to comply with the CENCENELEC Internal Regulations which stipulate the conditions for giving this. Sphere of EN 10412008.
Annex B informative Symbols and safety signs for marking. Information supplied by the manufacturer of medical devices. For the purposes of this Regulation the following definitions apply.
Correspondence between this document and the essential.
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