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ASTM F1415-92(2000)

Current Revision

Standard Specification for Pulse Oximeters (Withdrawn 2005)

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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.


SDO ASTM: ASTM International
Document Number F1415
Publication Date Jan. 1, 2000
Language en - English
Page Count 7
Revision Level 92(2000)
Supercedes
Committee F29.11
Publish Date Document Id Type View
Jan. 1, 2000 F1415-92R00 Revision
Jan. 1, 2000 F1415-92 Revision