ASTM F1415-92(2000) PDF

Scope: Full Description 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.

ASTM F1415-92(2000) Referenced Document

ASTM F1463 Standard Specification for Alarm Signals in Medical Equipment Used in Anesthesia and Respiratory Care *， 1993-01-01 Update
ISO 7250 Basic human body measurements for technological design*， 1996-07-01 Update