DIN EN ISO 20417:2024-12
Medical devices - Information to be supplied by the manufacturer (ISO/DIS 20417:2024); German and English version prEN ISO 20417:2024 / Note: Date of issue 2024-11-22*Intended as replacement for DIN EN ISO 20417 (2022-03).
| Fecha edición: |
2024-12-01
En Vigor
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| Idiomas disponibles: | Alemán, Inglés |
| Resumen: | NOTE 1 There is guidance or rationale for this Clause contained in Clause A.2. 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. NOTE 2 Some authorities having jurisdiction impose different requirements for the identification, marking and documentation of a medical device or accessory. 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: |
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