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ISO 20417:2021

Medical devices — Information to be supplied by the manufacturer
13. 4. 2021.

Опште информације

90.92     18. 12. 2023.

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 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.

Životni ciklus

TRENUTNO

OBJAVLJEN
ISO 20417:2021
90.92 Odluka o izmeni ili reviziji standarda
18. 12. 2023.

REVIDIRAN OD

PROJEKAT
ISO/DIS 20417

Nacionalna preuzimanja

SRPS EN ISO 20417:2022  
ISS

Medicinska sredstva – Informacije koje pruža proizvođač

60.60   Standard objavljen

Z210 Saznaj više