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ASTM F1415

1992 Edition, July 31, 1992

Complete Document

Standard Specification for Pulse Oximeters

Includes all amendments and changes through Reapproval Notice

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Product Details
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Detail Summary

Superseded By: ISO 9919

Additional Comments:
W/D S/S BY ISO 9919
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Product Details:

  • Revision: 1992 Edition, July 31, 1992
  • Published Date: January 2000
  • Status: Superseded By:
  • Superseded By: ISO 9919
  • Document Language: English
  • Published By: ASTM International (ASTM)
  • Page Count: 7
  • ANSI Approved: No
  • DoD Adopted: No

Description / Abstract:

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.