Objavljen
NOTE 1 There is guidance or rationale for this Clause in A.2.1.
This document specifies the requirements for information supplied by the manufacturer for a medical device or 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.
POVUČEN
ISO 20417:2021
OBJAVLJEN
ISO 20417:2026
60.60
Standard objavljen
17. 3. 2026.
Medicinska sredstva – Informacije koje pruža proizvođač
50.60 Završetak postupka odobravanja definitivnog teksta nacrta standarda
Medicinska sredstva – Informacije koje pruža proizvođač
50.60 Završetak postupka odobravanja definitivnog teksta nacrta standarda