This specification includes requirements for the safety and performance of pulse oximeters 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.
Formerly under the jurisdiction of Committee F29 on Anesthetic and Respiratory Equipment, this specification was withdrawn in May 2005 and replaced with the adoption of ISO 9919 as an American National Standard. Available from www.astm.org.
Область применения1.1 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.