NEN-EN-ISO 80601-2-12:2011 en

Withdrawn standard
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78 Pages
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Publication date 2011-05-01
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English
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Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
IEC 60601-1:2005, Clause 1 applies, except as follows: Subclause 1.1 of IEC 60601-1:2005, Clause 1 is replaced by: 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.
Extra information
Registration date
2020-03-01
Committee
301006
TC
CEN/TC 215
ICS code
11.040.10 Anaesthetic, Respiratory And Reanimation Equipment
Related to
ISO 80601-2-12:2011 en, IDT * EN ISO 80601-2-12:2011, IDT
Keywords
Breathing apparatus - Anaesthesiology - Anaesthetic equipment - Health services - Lungs - Lung ventilators - Medical equipment - Ventilators - Hospital equipment - Respiratory protective devices

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