ASTM-F1415:1992 Edition

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F1415-92 Standard Specification for Pulse Oximeters

Published By	Publication Date	Number of Pages
ASTM	1992	6

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Category: ASTM

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Description

ASTM F1415-92

Historical Standard: Standard Specification for Pulse Oximeters

ASTM F1415

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.

Keywords

alarms; anesthesia; intensive care; intraoperative use; neonatal use; oximeters; pediatrics; perioperative use; pulse oximeters; respiratory therapy; pulse oximeters

ICS Code

ICS Number Code n/a

DOI: 10.1520/F1415-92

Additional information