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STN EN ISO 80601-2-12

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Electronic version (pdc file)

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Name: STN EN ISO 80601-2-12
Validity: Valid
Number of pages: 172
Language:
EN
Paper: 36,30€
Electronic version a) Only read (without ability to print and copy) 32,67€
b) Without ability to print, with ability to copy (printscreen) 36,30€
c) With ability to print and copy (printscreen) 47,19€
Slovak title Zdravotnícke elektrické prístroje. Časť 2-12: Osobitné požiadavky na základnú bezpečnosť a nevyhnutné prevádzkové vlastnosti ventilátorov na intenzívnu starostlivosť (ISO 80601-2-12: 2023)
English title Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO 80601-2-12:2023)
Release Date: 01. 02. 2024
Date of withdrawal:
ICS: 11.040.10
Sorting character/National clasification code 85 2101
Level of incorporation: idt ISO 80601-2-12:2023, idt EN ISO 80601-2-12:2023
Official Journal 01/24
Amendments
Replaced by:
Repleces: STN EN ISO 80601-2-12:2020-07 (85 2101)
Note in Official Journal:
Subject of the standard: This document applies to the basic safety and essential performance of a critical care ventilator in combination with its accessories, hereafter referred to as ME equipment: 3 intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility; NOTE 2 For the purposes of this document, such an environment is referred to as a critical care environment. Ventilators for this environment are considered life-sustaining. NOTE 3 For the purposes of this document, such a critical care ventilator can provide ventilation during transport within a professional healthcare facility (i.e. be a transit-operable ventilator).
Preview: Náhľad normy (PDF)