YY/T 0754-2009: Particular requirements of the safety and essential performance for blood pressure transmission tubes for use with invasive blood pressure monitoring equipment

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Scope

This Standard specifies particular requirements of the safety and essential performance for
blood pressure transmission tubes for use with invasive blood pressure monitoring equipment
(it is referred to as "blood pressure transmission tubes" in this Standard). The tube involved in
this Standard transmits human blood pressure to the blood pressure sensor in an invasive
connection method by an intravascular catheter (for instance connecting the pressure
measurement tube of a central venous catheter to this tube).
This Standard does not involve requirements for other functions on the blood pressure
transmission tubes that are not directly related to blood pressure monitoring. For example, it
has a blood sample collection function.
The particular requirements for electrical safety and performance of sensors used in invasive
blood pressure monitoring devices are specified in other standards.

Basic Data

Standard ID	YY/T 0754-2009 (YY/T0754-2009)
Description (Translated English)	Particular requirements of the safety and essential performance for blood pressure transmission tubes for use with invasive blood pressure monitoring equipment
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C31
Classification of International Standard	11.040.20
Word Count Estimation	10,182
Date of Issue	2009-11-15
Date of Implementation	2010-12-01
Quoted Standard	GB/T 1962.2; GB 8368; YY 0286.4-2006; YY 0466; YY 0585.2-2005
Regulation (derived from)	Industry standard filing Notice 2010 No. 2 (No. 122 overall)
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies the use of invasive blood pressure monitoring equipment transfer line (the standard referred to as "blood pressure transmission pipeline") requirements for safety and performance. This standard involves intravascular catheter tubing is connected to invasive way (such as through the central venous catheter pressure piping and the piping connections) will be transmitted to the human blood pressure blood pressure sensor. This standard does not involve blood pressure monitor blood pressure transmission pipelines and other functions not directly related to the request. As with blood sampling function. Invasive blood pressure monitoring equipment with sensor electrical safety and performance requirements for the other standards.