ASTM F 1415 : 1992

CONTAINED IN VOL. 13.01, 2001 Includes requirements for the performance and safety of pulse oximeters meant for use in approximating the saturation of arterial hemoglobin, non-invasively from a light signal transmitted through the tissue, considering the pulsatile nature of volume changes with blood flow. Does not cover pulse oximeters meant for use in laboratory research applications and "bench" type oximeters that require a blood sample from a patient.

1.1 The scope given in Clause 1 of IEC 601-1 applies except that 1.1 shall be replaced by the following:

1.1.1 This specification includes requirements for the safety and performance of pulse oximeters, as defined in 3.8 intended for use in approximating the saturation of arterial hemoglobin, non-invasively, from a light signal transmitted through the tissue, taking into account the pulsatile nature of volume changes with blood flow.

1.2 The field of application includes, but is not limited to: intraoperative and perioperative use; adult critical care application; pediatric and neonatal application; and general determination of saturation on hospitalized and non-hospitalized patients.

1.3 Pulse oximeters intended for use in laboratory research applications and "bench" type oximeters that require a blood sample from the patient are outside the scope of this specification.