STN EN IEC 80601-2-71
| Name: | STN EN IEC 80601-2-71 |
| Validity: | Valid |
| Number of pages: | 46 |
| Language: |
EN
|
| Paper: | 18,90€ |
| Electronic version |
a) Only read (without ability to print and copy)
17,01€ b) Without ability to print, with ability to copy (printscreen) 18,90€ c) With ability to print and copy (printscreen) 24,57€ |
| 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. 11. 2018 |
| Date of withdrawal: | |
| ICS: | 11.040.55 |
| Sorting character/National clasification code | 36 4800 |
| Level of incorporation: | idt EN IEC 80601-2-71:2018, idt IEC 80601-2-71:2015 |
| Official Journal | 10/18 |
| Amendments | |
| Replaced by: | |
| Repleces: | |
| Note in Official Journal: | |
| Subject of the standard: | This International standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of FUNCTIONAL NIRS EQUIPMENT intended to be used by themselves, or as a part of an ME SYSTEM, for the production of FUNCTIONAL NIRS EQUIPMENT output for adjunctive diagnostic purposes, hereinafter referred to as ME EQUIPMENT. Not included within the scope of this particular standard are: a) the part of ME EQUIPMENT, if provided, that measures oxygen saturation of the haemoglobin in the micro vessels (capillaries, arterioles and venules); b) near-infrared spectroscopy (NIRS) tissue oximeter equipment, which is not intended for obtaining FUNCTIONAL NIRS EQUIPMENT output; c) pulse oximeter equipment, which is not intended for obtaining FUNCTIONAL NIRS EQUIPMENT output. The requirements for pulse oximeter equipment are found in ISO 80601-2-61. d) frequency-domain and time-domain equipment for functional near-infrared spectroscopy, which may require different test procedures than defined herein. e) FUNCTIONAL NEAR-INFRARED ... |
| Preview: | Náhľad normy (PDF) |