IEC 60601-2-12:2001
Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators; Critical care ventilators

Standard No.

IEC 60601-2-12:2001

Release Date

2001

Published By

International Organization for Standardization (ISO)

Status

Withdraw

Latest

IEC 60601-2-12:2001

Replace

ISO 10651-1:1993 IEC/FDIS 60601-2-12:2001

Scope

Addition:This Particular Standard specifies the safety requirements for VENTILATORS@ as defined in 2.1.125@ intended for use in critical care settings.Continuous positive airway pressure (CPAP) devices@ sleep apnea therapy devices@ support-care VENTILATORs@ emergency and transport VENTILATORs@ jet and high frequency VENTILATORs and oscillators are outside the scope of this Particular Standard@ nor are devices that may be used within hospitals@ intended solely to augment the ventilation of spontaneously breathing PATIENTS. Standards for other types of VENTILATORs@ e.g. high frequency jet and oscillation ventilators@ are under consideration.Requirements for VENTILATORs intended for anaesthetic applications are given in IEC 60601-2-13.

IEC 60601-2-12:2001 history

• 2001 IEC 60601-2-12:2001 Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators; Critical care ventilators
• 1988 IEC 60601-2-12:1988 Medical electrical equipment; part 2: particular requirements for the safety of lung ventilators for medical use

IEC 60601-2-12:2001 Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators; Critical care ventilators has been changed from ISO 10651-1:1993 Lung ventilators for medical use; part 1: requirements.