Recognized Consensus Standards

Recognition List Number: 019 Publication Date: 12/19/2007

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 1-65: ISO 21647:2004, Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors. (Anesthesias)

Date of Standard: 2004.

Address of Standards Organization:

International Organization for Standardization (ISO)*

1, Rue de Varembe

Case Postale 56

CH 1211 Geneva 20, 0

SWITZERLAND

CDRH Office and Division Associated with Recognized Standards:

	OFFICE OF DEVICE EVALUATION (ODE)

Devices Affected:

respiratory gas monitor (RGM) - medical electrical equipment intended to measure the gas level(s) or partial pressure(s) in respiratory gases, for example, anesthetic gas monitoring, carbon dioxide monitoring, and oxygen monitoring.The RGM consists of a complete monitor including accessories, sensor, and sampling tube (in the case of a diverting respiratory gas monitor) specified by the manufacturer

Processes Affected:

510(k), PMA, PDP, IDE, HDE, Design Control Input

Type of Standard:

International, Vertical

Extent of Recognition:

Complete standard and any annexes.

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
§868.1400	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Class 2	CCK

Regulation Number	Device Name	Device Class	Product Code
§868.1500	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Class 2	CBQ

Regulation Number	Device Name	Device Class	Product Code
§868.1620	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Class 2	CBS

Regulation Number	Device Name	Device Class	Product Code
§868.1690	Analyzer, Gas, Nitrogen, Gaseous-Phase	Class 2	CCI

Regulation Number	Device Name	Device Class	Product Code
§868.1700	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Class 2	CBR

Regulation Number	Device Name	Device Class	Product Code
§868.1720	Analyzer, Gas, Oxygen, Gaseous-Phase	Class 2	CCL