Hrvatski normativni dokument

Oznaka: HRN EN ISO 15223-1:2016

Naslov (HR):
Medicinski proizvodi -- Simboli za upotrebu u označivanju medicinskih proizvoda i informacijama uz medicinske proizvode -- 1. dio: Opći zahtjevi (ISO 15223-1:2016, ispravljena verzija 2017-03; EN ISO 15223-1:2016)

Naslov (EN):
Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03; EN ISO 15223-1:2016)

Napomena: Ispravljena verzija norme dostupna je od 2017-05-31.

Područje primjene (EN):
ISO 15223-1:2016 identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices. It also lists symbols that satisfy the requirements of this document.
ISO 15223-1:2016 is applicable to symbols used in a broad spectrum of medical devices, which are marketed globally and therefore need to meet different regulatory requirements.
These symbols may be used on the medical device itself, on its packaging or in the associated documentation. The requirements of this document are not intended to apply to symbols specified in other standards.

Izdanje: 2

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: 95.99 - povlačenje HRN

Glasilo (rasprava): HZN e-Glasilo 5/2015 (31.10.2015.)

Glasilo (objava): HZN e-Glasilo 6/2016 (31.12.2016.)

Glasilo (ispravak): HZN e-Glasilo 5/2017 (31.05.2017.)

Glasilo (povlačenje): 10/2021 (31.10.2021.)

Način prihvaćanja: pr - prihvaćanje strane norme u izvorniku

Izvornik: EN ISO 15223-1:2016

Zamjenjuje: HRN EN ISO 15223-1:2012

Zamjenjena s: HRN EN ISO 15223-1:2021

Direktiva/Uredba: 90/385/EEC, 93/42/EEC, 98/79/EC