ASTM F 1415 Standard Specification for Pulse Oximeters
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ASTM F 1415 Document Information:
Title
Standard Specification for Pulse Oximeters
ASTM International
Publication Date:
Jul 31, 1992
Scope:
1. 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 3.2.9 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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