HRN EN ISO 20417:2021
Medicinski proizvodi -- Informacije koje daje proizvođač (ISO 20417:2021, ispravljena verzija 2021-12; EN ISO 20417:2021)
| Oznaka: | HRN EN ISO 20417:2021 |
| Naslov (HR): | Medicinski proizvodi -- Informacije koje daje proizvođač (ISO 20417:2021, ispravljena verzija 2021-12; EN ISO 20417:2021) |
| Naslov (EN): | Medical Devices -- Information to be provided by the manufacturer (ISO 20417:2021, Corrected version 2021-12; EN ISO 20417:2021) |
| Napomena: | Ispravljena verzija norme dostupna je od 2022-02-28. |
| Područje primjene (EN): | 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. |
| Izdanje: | 1 |
| ICS: | 11.040.01 Medicinska oprema općenito |
| Tehnički odbor/pododbor: | TO 555, Medicinski proizvodi |
| Oznaka faze: | 60.60 - HRN dostupan |
| Glasilo (rasprava): | HZN e-Glasilo 4/2019 () |
| Glasilo (objava): | HZN e-Glasilo 5/2021 () |
| Glasilo (ispravak): | HZN e-Glasilo 2/2022 () |
| Način prihvaćanja: | pr - prihvaćanje strane norme u izvorniku |
| Cijena #1: | Cijena: 60,00 € | Jezik: en | Cjenovni razred: M | Broj stranica: 76 |
| Izvornik: | EN ISO 20417:2021 |
| Zamjenjuje: | HRN EN 1041:2013 |
| Direktiva/Uredba: | kandidat |
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