Standard Specification for Cutaneous Gas Monitoring Devices for Oxygen and Carbon Dioxide
|Publication Date:||27 March 1986|
1.1 This specification covers all devices intended for use as non-invasive monitoring systems of the partial pressure of oxygen or carbon dioxide at the skin's surface. This specification covers cutaneous monitors used with adults, children, and neonates, and may include the use of these devices in fetal monitoring prior to birth.
1.2 Current technology and clinical interpretative skills limit the primary application of these devices to indicate trends in the cutaneous partial pressure of oxygen and carbon dioxide, rather than to provide an absolute measurement.
1.3 Although the principal type of monitor in use at present involves the attachment of a sensor assembly with a heater to the skin's surface, this specification applies to all devices used to monitor partial pressure of gas at the skin's surface, regardless of the technique used to accomplish measurement.
1.4 This specification applies to devices manufactured following the adoption of this standard. This specification does not apply to hemoglobin saturation oximeters or to devices applied to surfaces of the body other than the skin (that is, conjunctiva, mucosa).
1.5 The following precautionary caveat pertains only to the test method portion, Sections 10, 11, 12, and 13 of this specification: This standard may involve hazardous materials, operations, and equipment. This standard does not purport to address all of the safety problems associated with its use. It is the responsibility of whoever uses this standard to consult and establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.