STN EN IEC 60601-2-39
| Name: | STN EN IEC 60601-2-39 |
| Validity: | Valid |
| Number of pages: | 64 |
| Language: |
EN
|
| Paper: | 24,40€ |
| Electronic version |
a) Only read (without ability to print and copy)
21,96€ b) Without ability to print, with ability to copy (printscreen) 24,40€ c) With ability to print and copy (printscreen) 31,72€ |
| Slovak title | Zdravotnícke elektrické prístroje. Časť 2-39: Osobitné požiadavky na základnú bezpečnosť a nevyhnutné prevádzkové vlastnosti prístrojov na peritoneálnu dialýzu |
| English title | Medical electrical equipment - Part 2-39: Particular requirements for the basic safety and essential performance of peritoneal dialysis equipment |
| Release Date: | 01. 05. 2025 |
| Date of withdrawal: | |
| ICS: | 11.040.99 |
| Sorting character/National clasification code | 36 4800 |
| Level of incorporation: | idt EN IEC 60601-2-39:2025, idt IEC 60601-2-39:2024 |
| Official Journal | 04/25 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN IEC 60601-2-39:2019-11 (36 4800) |
| Note in Official Journal: | |
| Subject of the standard: | IEC 60601-2-39:2024 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PERITONEAL DIALYSIS ME EQUIPMENT, hereafter referred to as PD EQUIPMENT. It applies to PD EQUIPMENT intended for use either by medical staff or under the supervision of medical experts, including PD EQUIPMENT operated by the PATIENT, regardless of whether the PD EQUIPMENT is used in a hospital or domestic environment. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. This document does not take into consideration specific safety details of the DIALYSING SOLUTION control system of PD EQUIPMENT using regeneration of DIALYSING SOLUTION or CENTRAL DELIVERY SYSTEMS for DIALYSING SOLUTION. It does, however, take into consideration the specific safety requirements of such PD EQUIPMENT concerning ... |
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