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DIN EN ISO 20417:2022-03

Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12); German version EN ISO 20417:2021 / Note: To be replaced by DIN EN ISO 20417 (2024-12).

Fecha edición: 2022-03-01
En Vigor
Idiomas disponibles: Inglés, Alemán
Resumen: 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 3.1. 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. This document does not specify the means by which the information is to be supplied. Specific requirements of medical device product standards or group standards take precedence over requirements of this document.

Keywords: Accessories|Accompanying forms|Colour|Control|Data of the manufacturer|Definitions|Documentation|Dressing materials|Enterprises|Identification|Implants (surgical)|Information|Information supplied by the manufacturer|Instructions for use|In-vitro diagnostic|Labelling|Labels|Legibility|Marking|Medical devices|Medical equipment|Medical instruments|Medical products|Medical sciences|Medical technology|Packages|Product information|Products|Provision|Specification (approval)|Surgical dressings|Symbols|Terminology
ICS: 11.040.01 - Equipo médico en general
CTN:

Equivalencia Internacional

Idéntica EN ISO 20417:2021

Idéntica ISO 20417:2021

Reemplazo Normas

Reemplaza a DIN EN ISO 20417:2021-12

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