Hrvatski normativni dokument

Oznaka: HRN EN ISO 15223-1:2021

Naslov (HR):
Medicinski proizvodi -- Simboli koji se upotrebljavaju s podacima koje osigurava proizvođač -- 1. dio: Opći zahtjevi (ISO 15223-1:2021; EN ISO 15223-1:2021)

Naslov (EN):
Medical devices -- Symbols to be used with information to be supplied by the manufacturer -- Part 1: General requirements (ISO 15223-1:2021; EN ISO 15223-1:2021)

Područje primjene (EN):
This document specifies symbols used to express information supplied for a medical device. This document is applicable to symbols used in a broad spectrum of medical devices, that are available globally and need to meet different regulatory requirements.
These symbols can be used on the medical device itself, on its packaging or in the accompanying information. The requirements of this document are not intended to apply to symbols specified in other standards.

Izdanje: 3

ICS:

• 01.080.20 Grafički simboli za upotrebu na posebnoj opremi
• 11.040.01 Medicinska oprema općenito

Tehnički odbor/pododbor: TO 555, Medicinski proizvodi

Oznaka faze: 60.60 - HRN dostupan

Glasilo (rasprava): HZN e-Glasilo 3/2020 (31.03.2020.)

Glasilo (objava): HZN e-Glasilo 10/2021 (31.10.2021.)

Način prihvaćanja: pr - prihvaćanje strane norme u izvorniku

Izvornik: EN ISO 15223-1:2021

Zamjenjuje: HRN EN ISO 15223-1:2016

Direktiva/Uredba: (EU) 2017/746, (EU) 2017/745