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Glavni meni

ISO 20417:2026

Medical devices — Information to be supplied by the manufacturer
17. 3. 2026.

Опште информације

60.60     17. 3. 2026.

ISO

ISO/TC 210

Međunarodni standard

11.040.01  

engleski   francuski  

Kupovina

Objavljen

Jezik na kome želite da primite dokument.

Apstrakt

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.

Životni ciklus

PRETHODNO

POVUČEN
ISO 20417:2021

TRENUTNO

OBJAVLJEN
ISO 20417:2026
60.60 Standard objavljen
17. 3. 2026.

Nacionalna preuzimanja

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