Standard Withdrawn, Replaced   Last Updated: Aug 17, 2017 Track Document
ASTM F1415-92(2000)

Standard Specification for Pulse Oximeters (Withdrawn 2005)

Standard Specification for Pulse Oximeters (Withdrawn 2005) F1415-92R00 ASTM|F1415-92R00|en-US Standard Specification for Pulse Oximeters (Withdrawn 2005) Standard new BOS Vol. 13.02 Committee F29
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Scope

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.

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