STN EN ISO 20417
| Označenie: | STN EN ISO 20417 |
| Platnosť: | Zrušená |
| Počet strán: | 84 |
| Jazyk: |
EN
|
| Listinná verzia: | 28,80€ |
| Elektronická verzia: |
a) Bez možnosti tlače, prenosu textu a obrázkov:
25,92€ b) Bez možnosti tlače, s prenosom textu a obrázkov: 28,80€ c) S možnosťou tlače, prenosu textu a obrázkov: 37,44€ |
| Slovenský názov: | Zdravotnícke pomôcky. Informácie poskytované výrobcom (ISO 20417: 2021) |
| Anglický názov: | Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021) |
| Dátum vydania: | 01. 09. 2021 |
| Dátum zrušenia: | 01. 03. 2022 |
| ICS: | 11.040.01 |
| Triediaci znak: | 85 5201 |
| Úroveň zapracovania: | idt EN ISO 20417:2021, idt ISO 20417:2021 |
| Vestník: | 08/21 |
| Zmeny: | |
| Nahradzujúce normy: | STN EN ISO 20417:2022-03 (85 5201) |
| Nahradené normy: | STN EN 1041+A1:2014-01 (85 5201) |
| Poznámka vo Vestníku: | |
| Predmet normy: | 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. |
| Náhľad normy: | Náhľad normy (PDF) |