Staða:
Umsagnarfrestur til - 18.2.2026Íslenskt heiti:
Lækningatæki - Upplýsingar sem framleiðanda ber að veitaEnskt heiti:
Medical devices - Information to be supplied by the manufacturer (ISO/FDIS 20417:2025)Tengdur staðall:
ISO/FDIS 20417:2025Tækninefnd:
CEN/CLC/JTC 3ICS flokkur:
11.040Auglýst:
8.1.2026Umfang (scope):
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.