SS-EN ISO 80601-2-12 :2011现行
Medical Electrical Equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO 80601-2-12:2011)
出版：Standardiserings-Kommissionen I Sverige
专家解读视频
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a VENTILATOR in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT:? - intended to be attended by a professional OPERATOR for those PATIENTS who are dependent on mechanical ventilation; and? NOTE 1 Such VENTILATORS are considered a LIFE-SUPPORTING ME EQUIPMENT OR ME SYSTEM.? - intended for use in critical care environments in a professional healthcare facility or intended for use in transport within a professional healthcare facility.
