STN EN IEC 60601-2-16
| Name: | STN EN IEC 60601-2-16 |
| Validity: | Valid |
| Number of pages: | 112 |
| Language: |
EN
|
| Paper: | 31,80€ |
| Electronic version |
a) Only read (without ability to print and copy)
28,62€ b) Without ability to print, with ability to copy (printscreen) 31,80€ c) With ability to print and copy (printscreen) 41,34€ |
| Slovak title | Zdravotnícke elektrické prístroje. Časť 2-16: Osobitné požiadavky na základnú bezpečnosť a nevyhnutné prevádzkové vlastnosti hemodialyzačných, hemodiafiltračných a hemofiltračných prístrojov |
| English title | Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment |
| Release Date: | 01. 05. 2025 |
| Date of withdrawal: | |
| ICS: | 11.040.20, 11.040.25 |
| Sorting character/National clasification code | 36 4800 |
| Level of incorporation: | idt EN IEC 60601-2-16:2025, idt IEC 60601-2-16:2025 |
| Official Journal | 04/25 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN IEC 60601-2-16:2019-11 (36 4800) |
| Note in Official Journal: | |
| Subject of the standard: | IEC 60601-2-16:2025 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT, hereafter referred to as HAEMODIALYSIS EQUIPMENT. It applies to HAEMODIALYSIS EQUIPMENT intended for use either by medical staff or under the supervision of medical experts, including HAEMODIALYSIS EQUIPMENT operated by the PATIENT, regardless of whether the HAEMODIALYSIS 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 DIALYSIS FLUID control system of HAEMODIALYSIS EQUIPMENT using regeneration of DIALYSIS FLUID or CENTRAL DELIVERY SYSTEMS for DIALYSIS FLUID. It does, however, take into ... |
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