YY/T 1536-2017Catheters other than intravascular catheters-Standard test model for evaluating the surface sliding performance (English PDF)

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

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.

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