Respiratory Gas Monitors Products (HS code(s): 901819); (ICS code(s): 11.040.10)

National Standard of the P.R.C., Medical Electrical Equipment-Part 2-55:Particular Requirements for the Basic Safety and Essential Performance of Respiratory Gas Monitors; (48 page(s), in Chinese)

This document specifies particular requirements for the basic safety and essential performance of a respiratory gas monitor (RGM) and the requirements are listed as follows:

·                anaesthetic gas monitoring,

·                carbon dioxide monitoring, and

·                oxygen monitoring.

NOTE 1: An RGM can be used as a stand-alone ME EQUIPMENT or integrated into other equipment, such as an anesthetic workstation or a ventilator.

This document is not applicable to an RGM intended for use with flammable anesthetic agents.