HRN EN ISO 11197:2016
Medicinski opskrbni uređaji (ISO 11197:2016; EN ISO 11197:2016)
| Oznaka: | HRN EN ISO 11197:2016 |
| Naslov (HR): | Medicinski opskrbni uređaji (ISO 11197:2016; EN ISO 11197:2016) |
| Naslov (EN): | Medical supply units (ISO 11197:2016; EN ISO 11197:2016) |
| Područje primjene (EN): | IEC 60601-1:2005+A1:2012, 1.1 is replaced by: ISO 11197:2016 applies to the basic safety and essential performance of medical supply units, hereafter also referred to as me equipment. ISO 11197:2016 applies to medical supply units manufactured within a factory or assembled on site, including cabinetry and other enclosures, which incorporate patient care services. NOTE 1 A party that assembles on site various components intended for patient care services into an enclosure is considered the manufacturer of the medical supply unit. Hazards inherent in the intended function of me equipment or me systems within the scope of this International Standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of IEC 60601-1:2005+A1:2012 (see 201.1.4). NOTE 2 See also IEC 60601-1:2005+A1:2012, 4.2. |
| Izdanje: | 3 |
| ICS: | 11.040.10 Anestezijska, respiracijska i reanimacijska oprema |
| Tehnički odbor/pododbor: | TO 121, Anestetička i respiracijska oprema |
| Oznaka faze: | 95.99 - povlačenje HRN |
| Glasilo (rasprava): | HZN Glasilo 6/2012 () |
| Glasilo (objava): | HZN e-Glasilo 2/2016 () |
| Glasilo (povlačenje): | HZN e-Glasilo 12/2019 () |
| Način prihvaćanja: | pr - prihvaćanje strane norme u izvorniku |
| Cijena #1: | Cijena: 41,00 € | Jezik: en | Cjenovni razred: G | Broj stranica: 32 |
| Izvornik: | EN ISO 11197:2016 |
| Zamjenjuje: | HRN EN ISO 11197:2010 |
| Zamjenjena s: | HRN EN ISO 11197:2019 |
| Direktiva/Uredba: | kandidat |
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