STN EN IEC 80601-2-71
| Name: | STN EN IEC 80601-2-71 |
| 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 2-71: Osobitné požiadavky na základnú bezpečnosť a nevyhnutné prevádzkové vlastnosti prístrojov na funkčnú spektroskopiu v blízkej infračervenej oblasti (NIRS) |
| English title | Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment |
| Release Date: | 01. 05. 2025 |
| Date of withdrawal: | |
| ICS: | 11.040.55 |
| Sorting character/National clasification code | 36 4800 |
| Level of incorporation: | idt EN IEC 80601-2-71:2025, idt IEC 80601-2-71:2025 |
| Official Journal | 04/25 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN IEC 80601-2-71:2018-11 (36 4800) |
| Note in Official Journal: | |
| Subject of the standard: | IEC 80601-2-71:2025 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of FUNCTIONAL NIRS EQUIPMENT, as defined in 201.3.205, intended to be used by itself, or as a part of an ME SYSTEM hereinafter referred to as ME EQUIPMENT. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, 7.2.13 and 8.4.1. This document is not applicable to – equipment for the measurement of oxygen saturation of the haemoglobin in the micro vessels (capillaries, arterioles and venules), i.e. tissue oximeters; – frequency-domain and time-domain equipment for functional near-infrared spectroscopy; – equipment for the measurement of changes in the concentration of chromophores other than oxy- and deoxy-haemoglobin; – equipment for the measurement of changes in the concentration of oxy- and deoxy-haemoglobin in tissues ... |
| Preview: | Náhľad normy (PDF) |