DIN EN 1041:2013-12
Information supplied by the manufacturer of medical devices; German version EN 1041:2008+A1:2013
| Fecha edición: |
2021-12-01
Anulada
|
|---|---|
| Fecha de anulación: | 2021-12-01 |
| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This 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 does not 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 of conformity with the relevant Essential Requirements regarding information to be supplied. This standard does not cover requirements for provision of information for in vitro diagnostic medical devices, which are covered by other labelling standards (see Bibliography). |
| Keywords: | Accessories|Colour|Control|Data of the manufacturer|Definitions|Dressing materials|Enterprises|Implants (surgical)|Information|Instructions for use|In-vitro diagnostic|Legibility|Marking|Medical devices|Medical equipment|Medical instruments|Medical products|Medical sciences|Medical technology|Product information|Products|Provision|Specification (approval)|Surgical dressings|Symbols|Terminology |
| ICS: | 11.120.01 - Productos farmacéuticos en general, 11.040.01 - Equipo médico en general, 01.110 - Documentación técnica de los productos |
| CTN: | |
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Reemplazo Normas |
Reemplaza a DIN EN 1041:2008-11 Reemplaza a DIN EN 1041/A1:2013-01 Es reemplazada por DIN EN ISO 20417:2021-12 |










