HRN EN 62366:2008
Medicinski uređaji -- Primjena prikladnog oblikovanja i konstrukcije medicinskih uređaja (IEC 62366:2007; EN 62366:2008)
| Oznaka: | HRN EN 62366:2008 |
| Naslov (HR): | Medicinski uređaji -- Primjena prikladnog oblikovanja i konstrukcije medicinskih uređaja (IEC 62366:2007; EN 62366:2008) |
| Naslov (EN): | Medical devices -- Application of usability engineering to medical devices (IEC 62366:2007; EN 62366:2008) |
| Područje primjene (EN): | Specifies a process for a manufacturer to analyse, specify, design, verify and validate usability, as it relates to safety of a medical device. This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, i.e. normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use. If the usability engineering process detailed in this International Standard has been complied with and the acceptance criteria documented in the usability validation plan have been met, then the residual risks, as defined in ISO 14971, associated with usability of a medical device are presumed to be acceptable, unless there is objective evidence to the contrary. This International Standard does not apply to clinical decision-making relating to the use of a medical device. |
| Izdanje: | 1 |
| ICS: | 11.040 Medicinska oprema |
| Tehnički odbor/pododbor: | TO E62, Električna oprema u medicinskoj praksi |
| Oznaka faze: | 95.99 - povlačenje HRN |
| Glasilo (rasprava): | HZN Glasilo 5/2008 () |
| Glasilo (objava): | HZN Glasilo 6/2008 () |
| Glasilo (ispravak): | 4/2013 () |
| Glasilo (povlačenje): | 4/2018 () |
| Način prihvaćanja: | pr - prihvaćanje strane norme u izvorniku |
| Cijena #1: | Cijena: 69,00 € | Jezik: en | Cjenovni razred: O | Broj stranica: 103 |
| Izvornik: | EN 62366:2008 |
| Zamjenjuje: | HRN IEC 62366:2008 |
| Zamjenjena s: | HRN EN 62366-1:2015 |
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