BAS EN ISO 15223-1:2018
Medicinska sredstva - Simboli za upotrebu u označavanju medicinskih sredstava, oznake i informacije uz medicinske proizvode – Dio 1: Opći zahtjevi
Opšte informacije
Status: Povučen
Broj strana: 36
Jezik: Engleski
Izdanje: 2.
Metoda usvajanja: Proglašavanje
Datum objave: 29.08.2018
Tehnički komitet:
Direktiva:
90/385/EEC, Aktivna ugradiva medicinska sredstva;
93/42/EEC, Medicinska sredstva
98/79/EC, Medicinska sredstva u in vitro dijagnostici;
93/42/EEC, Medicinska sredstva
98/79/EC, Medicinska sredstva u in vitro dijagnostici;
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Apstrakt
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.
Životni ciklus
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Izvorni dokument i stepen usklađenosti
- EN ISO 15223-1:2016, identičan
- ISO 15223-1:2016, identičan