ASTM F 1415 : 1992

Name: ASTM F 1415 : 1992
Brand: ASTM
Price: 62.61 GBP

Superseded

View Superseded by

Standard Specification for Pulse Oximeters

Available format(s)

Hardcopy , PDF

Superseded date

11-11-2014

Language(s)

English

Published date

01-01-2000

Publisher

American Society for Testing and Materials

CONTAINED IN VOL. 13.01, 2001 Includes requirements for the performance and safety of pulse oximeters meant for use in approximating the saturation of arterial hemoglobin, non-invasively from a light signal transmitted through the tissue, considering the pulsatile nature of volume changes with blood flow. Does not cover pulse oximeters meant for use in laboratory research applications and "bench" type oximeters that require a blood sample from a patient.

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.

Committee	F 29
DocumentType	Standard
Pages	6
ProductNote	Reconfirmed 1992
PublisherName	American Society for Testing and Materials
Status	Superseded
SupersededBy	ISO 9919:2005 ASTM F 1415 : 1992 : R2000

ISO 7250:1996	Basic human body measurements for technological design
IEC 60601-1:2005+AMD1:2012 CSV	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60079-3:1990	Electrical apparatus for explosive gas atmospheres - Part 3: Spark-test apparatus for intrinsically-safe circuits
IEC 60801-2:1991	Electromagnetic compatibility for industrial-process measurement and control equipment - Part 2: Electrostatic discharge requirements