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ASTM F 1415 : 1992 : R2000

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

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withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Standard Specification for Pulse Oximeters (Withdrawn 2005)
Available format(s)

Hardcopy , PDF

Withdrawn date

01-01-2005

Language(s)

English

Published date

31-12-2010

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
7
ProductNote
Reconfirmed 2000
PublisherName
American Society for Testing and Materials
Status
Withdrawn
SupersededBy
Supersedes

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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Hardcopy - English
PDF - English
Hardcopy - English
PDF - English
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