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YY/T 1536-2017 English PDF

YY/T 1536-2017 (YY/T1536-2017, YYT 1536-2017, YYT1536-2017)
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YY/T 1536-2017English159 Add to Cart 3 days [Need to translate] Catheters other than intravascular catheters—Standard test model for evaluating the surface sliding performance Valid YY/T 1536-2017
Standards related to: YY/T 1536-2017

BASIC DATA
Standard ID YY/T 1536-2017 (YY/T1536-2017)
Description (Translated English) Catheters other than intravascular catheters--Standard test model for evaluating the surface sliding performance
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C31
Classification of International Standard 11.040.20
Word Count Estimation 8,899
Date of Issue 2017-03-28
Date of Implementation 2018-04-01
Drafting Organization Shandong Hanson detection technology development center
Administrative Organization National Medical Infusion Equipment Standardization Technical Committee (SAC/TC 106)
Regulation (derived from) China Food & Drug Administration Announcement 2017 No. 38
Proposing organization National Medical Infusion Equipment Standardization Technical Committee (SAC/TC 106)
Issuing agency(ies) State Food and Drug Administration

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 ...