ÖNORM EN ISO 80601-2-87:2021 10 15
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Medical electrical equipment - Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators (ISO 80601-2-87:2021)
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German - English
15-10-2021
Clause 1 of IEC 60601-1:2005+AMD1:2012+AMD2:2020 applies, except as follows: Replacement: This document applies to the basic safety and essential performance of a high-frequency ventilator (HFV) in combination with its accessories, hereafter referred to as ME equipment: - 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; - intended to be operated by a healthcare professional operator; - intended for those patients who need differing levels of support from artificial ventilation including ventilator-dependent patients; and - capable of providing more than 150 inflations/min.
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