ASTM ANS/IEC 60601.2.12:2001
Medical Electrical Equipment8212;Part 2-12; Particular Requirements for the Safety of Lung Ventilators8212;Critical Care Ventilators Approved as an American National Standard with Deviations by ASTM International

Standard No.

ASTM ANS/IEC 60601.2.12:2001

Release Date

2001

Published By

American Society for Testing and Materials (ASTM)

Status

Withdraw

Scope

This clause of the General Standard applies, except as follows:

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.