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Standard Specification for Pulse Oximeters
STANDARD published on 1.1.2000
Designation standards: ASTM F1415-92
Note: WITHDRAWN
Publication date standards: 1.1.2000
SKU: NS-50210
The number of pages: 7
Approximate weight : 21 g (0.05 lbs)
Country: American technical standard
Category: Technical standards ASTM
Keywords:
alarms, anesthesia, intensive care, intraoperative use, neonatal use, oximeters, pediatrics, perioperative use, pulse oximeters, respiratory therapy, pulse oximeters
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 3.8 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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