ASTM F 1415 : 1992
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Standard Specification for Pulse Oximeters
Hardcopy , PDF
11-11-2014
English
01-01-2000
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.
Committee |
F 29
|
DocumentType |
Standard
|
Pages |
6
|
ProductNote |
Reconfirmed 1992
|
PublisherName |
American Society for Testing and Materials
|
Status |
Superseded
|
SupersededBy |
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.
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 |
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