YY/T 1536-2017 (YYT 1536-2017)

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Related Standard	Status	PDF
YY/T 1536-2017	English	159	Add to Cart	3 days	Catheters other than intravascular catheters—Standard test model for evaluating the surface sliding performance	YY/T 1536-2017	Valid	YY/T 1536-2017

YY/T 1536-2017
Catheters other than intravascular catheters-Standard test model for evaluating the surface sliding performance
ICS 11.040.20
C31
People's Republic of China pharmaceutical industry standards
Non-intravascular catheters
Standard Test Model for Evaluation of Surface Slip Properties
2017-03-28 Posted
2018-04-01 implementation
State Food and Drug Administration released
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of this document may be patentable. The issuing agencies of this document do not bear the responsibility of identifying these patents.
This standard by the National Medical Devices Standardization Technical Committee (SAC/TC106) and focal point.
The main drafting units of this standard. Shandong Hanson testing technology development center.
Participated in the drafting of this standard. Shandong more than 100 Medical Devices Co., Ltd..
The main drafters of this standard. Yu Xiaohui, Sun Haipeng, Zhang Haijun.
introduction
One-time use of non-intravascular catheters is widely used clinically. In order to reduce the friction of the catheter into the body and reduce the suffering of patients,
To achieve lubrication, prevent infection and other effects, usually in the catheter surface coating treatment. The coated catheters will generally have their own distinct sound
Said the most common is claimed to be "super slippery." How to evaluate the one-time use of non-intravascular catheters that claim to be "ultra-slip"
Have not solved the problem.
This standard gives a standard test model for evaluating the sliding properties of disposable non-intravascular catheters, but does not provide for specific
Evaluation method. When using this model to establish the evaluation method, it is necessary to confirm the evaluation method according to the product characteristics and specific applications to obtain the subjects
Evaluation results of the school.
Non-intravascular catheters
Standard Test Model for Evaluation of Surface Slip Properties
1 Scope
This standard specifies the evaluation of one-time use of non-intravascular catheters (hereinafter referred to as the catheter) the standard sliding surface test model and model
application.
The model specified in this standard is suitable for evaluation of catheters entering the body with a lubricious coating or purported to be ultra-smooth (low resistance).
Note. Appendix A gives an example of a method for assessing catheter gliding performance using this model.
2 test model
2.1 test device
2.1.1 catheter sliding performance test device shown in Figure 1.
Size .mm
a) Clamping system b) Key dimensions of sliding clamps and clamps
c) Chute and cylinder installation d) test device assembly
Figure 1 catheter sliding performance test device schematic