HRN CEN/TS 14507-1:2004
Sustavi za udisanje dušičnog oksida -- 1. dio: Sustavi dobave (CEN/TS 14507-1:2003)
| Oznaka: | HRN CEN/TS 14507-1:2004 |
| Naslov (HR): | Sustavi za udisanje dušičnog oksida -- 1. dio: Sustavi dobave (CEN/TS 14507-1:2003) |
| Naslov (EN): | Inhalational nitric oxide systems -- Part 1: Delivery systems (CEN/TS 14507-1:2003) |
| Područje primjene (EN): | This Part of CEN/TS 14507 refers to EN 60601 1:1990 Medical electrical equipment - Part 1: General requirements for safety, as amended by its amendments 1 (1991) and 2 (1995). For brevity Part 1 is referred to in this Part of CEN/TS 14507 either as the General Standard or as the General requirements. The scope given in clause 1 of the General Standard applies except that 1.1 is replaced by the following: 1.1 This Part of CEN/TS 14507 specifies particular requirements for inhalational nitric oxide delivery systems and their modules. It covers devices which can be supplied in combined units, integrated into another medical device, for example a lung ventilator, or as individual devices. This Part of CEN/TS 14507 addresses the monitoring of nitric oxide and oxygen delivery to the patient and minimization of the production of nitrogen dioxide. This Part of CEN/TS 14507 covers the requirements for inhalational nitric oxide delivery systems intended for medical use, for example, in critical care, anaesthesia, and emergency/transport environments. NOTE It is recognized that from time to time innovations and designs will appear that offer advantages and yet are not covered by specific safety-related design or performance aspects of this Part of CEN/TS 14507; such innovations are not to be discouraged. As the techniques and technologies in these innovations advance, it is essential that the safety objectives of this Part of CEN/TS 14507 are considered as minimum requirements. The requirements of clause 1.3 of the General Standard apply with the following additions: The numbering of clauses and subclauses of this Part of CEN/TS 14507 corresponds to that of the General Standard. The changes to the text of the General Standard are specified by the use of the following words: ´Replacement´ means that the clause or subclause of the General Standard is replaced completely by the text of this Part of CEN/TS 14507. (...) |
| Izdanje: | 1 |
| ICS: | 11.040.10 Anestezijska, respiracijska i reanimacijska oprema |
| Tehnički odbor/pododbor: | TO 121, Anestetička i respiracijska oprema |
| Oznaka faze: | 60.60 - HRN dostupan |
| Glasilo (rasprava): | Glasilo DZNM 4-6/2004 () |
| Glasilo (objava): | Glasilo DZNM 7-9/2004 () |
| Način prihvaćanja: | pr - prihvaćanje strane norme u izvorniku |
| Cijena #1: | Cijena: 41,00 € | Jezik: en | Cjenovni razred: G | Broj stranica: 27 |
| Izvornik: | CEN/TS 14507-1:2003 |
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